A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified February 2026 by Novartis Pharmaceuticals
Sponsor
Novartis Pharmaceuticals
Information Provided by (Responsible Party)
Novartis Pharmaceuticals
Clinicaltrials.gov Identifier
NCT03701334
Other Study ID Numbers:
CLEE011O12301C
First Submitted
September 20, 2018
First Posted
October 9, 2018
Last Update Posted
March 31, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

The trial will include pre and postmenopausal women and men with HR-positive, HER2-negative EBC, with an Anatomic Stage Group III, IIB or a subset of Stage IIA cases, after adequate surgical resection, radiotherapy (if indicated), adjuvant or neoadjuvant chemotherapy (if indicated), and who are deemed to be eligible for adjuvant ET for at least 60 months of duration.

Approximately 5,000 patients will be randomized (using an Interactive Response Technology system \[IRT\]) into two treatment arms in a 1:1 ratio to:

• Investigational arm:

\~ Ribociclib 400 mg by mouth once daily on days 1 to 21 of a 28-day cycle, for 36 months since randomization (approximately 39 cycles).

And

\~ ET consisting of:

* For postmenopausal women: letrozole 2.5 mg by mouth once daily continuously or anastrozole 1 mg by mouth once daily continuously.

* For premenopausal women and men: letrozole 2.5 mg by mouth once daily continuously or anastrozole 1 mg by mouth once daily continuously, combined with goserelin 3.6 mg subcutaneously once every 4 weeks.

Duration of ET in the trial will be 60 months from the randomization date.

• Control arm:

\~ ET: Same as in the Investigational arm.

In both arms, ET will be administered according to the local clinical guidelines and current local prescribing information. Subsequent ET (or any other anti-cancer treatment) given after the protocol-required 60 months of ET (or after premature discontinuation of ET in the trial) will be administered according to the Investigator's clinical judgment and is not considered a trial treatment.

Randomization will be stratified by the following factors:

* Menopausal status: premenopausal women and men vs. postmenopausal women

* AJCC 8th edition Anatomic Stage Group: Anatomic Stage Group II vs. Anatomic Stage Group III

* Prior neoadjuvant/adjuvant chemotherapy: yes vs. no

* Geographical region: North America/Western Europe/Oceania vs. rest of the world

Enrollment of patients with Anatomic Stage Group II is capped at approximately 2,000 patients.

The trial will include screening, treatment, and follow up phases. The trial includes an exploratory component that requires collection of tumor and blood samples (except for patients enrolled in China).

Condition or DiseaseIntervention/Treatment
Early Breast Cancer
Drug: RibociclibOther: Endocrine Therapy (ET)

Study Design

Study TypeInterventional
Actual Enrollment5101 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)
Study Start DateDecember 6, 2018
Actual Primary Completion Date4yrs 5d from now
Actual Study Completion Date4yrs 5d from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Ribociclib + Endocrine Therapy (ET)
Eligible participants will receive Ribociclib 400 mg once daily on days 1 to 21 of a 28-day cycle, followed by 7 days off ribociclib (Days 22 to 28). And Endocrine Therapy (ET) consisting of: * For postmenopausal women: \- Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously. * For premenopausal women and men: * Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously, combined with: * Goserelin 3.6 mg subcutaneously once every 4 weeks.
Drug: Ribociclib
Ribociclib orally taken at 400 mg on days 1 to 21 of a 28-day cycle
Endocrine Therapy (ET)
Eligible participants will receive Endocrine Therapy (ET) consisting of: * For postmenopausal women: \- Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously. * For premenopausal women and men: * Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously, combined with: * Goserelin 3.6 mg subcutaneously once every 4 weeks.
Other: Endocrine Therapy (ET)
Endocrine Therapy (ET) will be administered according to the local clinical guidelines and current local prescribing information

Outcome Measures

Primary Outcome Measures
  1. Invasive Disease-Free Survival (iDFS)
    Invasive Disease-Free Survival (iDFS) is defined as the time from the date of randomization to the date of the first event of local invasive breast recurrence, regional invasive recurrence, distant recurrence, death (any cause), contralateral invasive BC, or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin). iDFS will be assessed locally using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials).
Secondary Outcome Measures
  1. Recurrence-free survival (RFS)
    Recurrence-free survival (RFS) is defined as the time from date of randomization to date of first event of local invasive breast recurrence, regional invasive recurrence, distant recurrence, or death (any cause) and will be assessed using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials).
  2. Distant disease-free survival (DDFS)
    Distant disease-free survival (DDFS) is defined as the time from date of randomization to date of first event of distant recurrence, death (any cause), or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin) and will be assessed using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials).
  3. Overall Survival (OS)
    Overall Survival (OS) is defined as the time from date of randomization to date of death due to any cause.
  4. Change from baseline in the global health status Quality of life scale score as assessed by EORTC QLQ-C30
    The EORTC QLQ-C30 contains functional scales, symptom scales, single items scale and a global health status/QoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
  5. Change from baseline in the physical functioning sub-scale score as assessed by EORTC QLQ-C30
    The EORTC QLQ-C30 contains functional scales, symptom scales, single items scale and a global health status/QoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
  6. Trough Concentration on Day 15 (Ctrough,D1) of ribociclib
    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of participants. Ctrough,D15 of ribociclib will be listed and summarized using descriptive statistics.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Inclusion Criteria 1. Signed and dated Patient Informed Consent Form (PICF) obtained prior to any trial-specific screening procedure. 2. Patient is ≥ 18 years-old at the time of PICF signature. 3. Patient is female with known menopausal status at the time of randomization or initiation of adjuvant ET (whichever occurs earlier), or male. Postmenopausal status is defined as:
Patient underwent bilateral oophorectomy, or
Age ≥ 60 years, or
Age \< 60 years and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene or ovarian suppression) and Follicle-stimulating hormone (FSH) and plasma estradiol are in the postmenopausal ranges per local normal ranges.
If taking tamoxifen or toremifene and age \<60 years, then FSH and plasma estradiol level in postmenopausal ranges. Notes
In women who are premenopausal at the beginning of adjuvant chemotherapy, amenorrhea is not a reliable indicator of menopausal status as ovarian function may still be intact or resume despite anovulation/amenorrhea. For these women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol per local clinical guidelines are required for determination of postmenopausal status.
All women who do not meet the criteria for postmenopausal status are considered premenopausal for the purpose of this trial. 4. Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis (i.e. date of the pathology report that confirmed the BC diagnosis) within 18 months prior to randomization. Patient with a multicentric and/or multifocal tumor is eligible if all histopathologically examined lesions meet the pathologic criteria in inclusion criteria 5 and 6. 5. Patient has breast cancer that is positive for ER and/or PgR according to the local laboratory as determined on the most recently analyzed tissue sample. 6. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the HER2-negative status (based on the most recently analyzed tissue sample tested by a local laboratory). 7. Patient (except those enrolled in China) has available archival tumor tissue from the surgical specimen, for submission to a central laboratory (Note: in patients that underwent neoadjuvant systemic therapy and had a pathologic complete response, archival tumor tissue at the time of the initial diagnosis or before the administration of neoadjuvant therapy is mandatory). 8. Patient, after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:
Anatomic Stage Group III, or
Anatomic Stage Group IIB, or
Anatomic Stage Group IIA (subset) Notes:
For patients whose tumors are Anatomic Stage IIA, N0:
If Grade is 1 or unknown (Gx), patient is not eligible.
If Grade 2, the gene expression test results (by Oncotype DX, Prosigna/PAM50, MammaPrint or EndoPredict EPclin) or Ki67 levels should be used if obtained as per local practice (i.e. are not mandatory for the purpose of the trial). Results must be available at screening.
Patients that received neoadjuvant treatment must meet the above criteria (for stage, and if Stage IIA, N0, also for grade and Ki67 or gene expression test) in any presurgical staging/sample and/or in the surgical specimen.
Categorization into the AJCC 8th edition Anatomic Stage Groups requires determination of the T, N and M categories. ALND is the preferred method for axillary lymph node staging, however SLN dissection can be used to determine the N category in the following cases:
No metastasis in SLN (patient is considered as pN0).
Only micrometastasis in SLN (patient is considered as pN1mi).
Patients with T1-2 and no clinically-evident nodes prior to surgery, no neoadjuvant chemotherapy, at least one macrometastasis in 1 or 2 SLNs, no matted nodes or gross extranodal disease at the time of SLN dissection (patient is considered as pN1). In all other cases, ALND is required to determine the N category. 9. If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according to the institutional guidelines, prior to screening. 10. If indicated, patient has completed adjuvant radiotherapy according to the institutional guidelines, prior to screening. 11. Patient has no contraindication for the adjuvant ET in the trial and is planned to be treated with ET for 5 years (since randomization date) or more. 12. Patient may have already received any standard neoadjuvant and/or adjuvant ET at the time of PICF signature, but randomization should occur within 12 months of the initial start date of ET. Ovarian suppression or short term ET for fertility preservation is not considered neoadjuvant/adjuvant ET. If patient was receiving tamoxifen or toremifene as adjuvant ET, a washout period of 5 half-lives (i.e. 35 days) prior to randomization is required (during that period patient can take AI). 13. Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 14. Patient has adequate bone marrow and organ function as defined by the following local laboratory values:
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
Platelets ≥ 100 × 109/L
Hemoglobin ≥ 9.0 g/dL
Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m2 according to the Modification of Diet in Renal Disease (MDRD) formula
Alanine transaminase (ALT) \< 2.5 × Upper Limit Normal (ULN)
Aspartate transaminase (AST) \< 2.5 × ULN
Total serum bilirubin \< ULN; or total bilirubin ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN in patients with well documented Gilbert's Syndrome
International normalized ratio (INR) ≤ 1.5 (unless the patient is receiving anticoagulants and the INR is within the therapeutic range of intended use for that anticoagulant within 7 days prior to randomization)
Patient must have the following laboratory values within normal limits or corrected to within normal limits with supplements (the local laboratory value should be documented within normal limits after the correction) before randomization:
Potassium
Magnesium
Total Calcium (corrected for serum albumin) 15. Standard 12-lead ECG values assessed by a central laboratory, as:
QTcF interval (QT interval using Fridericia's correction) at screening \< 450 milliseconds (msec)
Resting heart rate 50-90 beats per minute (determined from the ECG) 16. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures. 17. Women of childbearing potential (CBP), defined as all women physiologically capable of becoming pregnant (see Inclusion Criterion #18 for additional information), must have confirmed negative serum pregnancy test (for β-hCG) within 14 days prior to randomization. 18. Women of CBP must be willing to use highly effective methods of contraception. Contraception must continue during the trial treatment and for 21 days after stopping the treatment. Highly effective contraception methods include:
Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before taking trial treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
Male partner sterilization (at least 6 months prior to randomization). For female patients on the trial the vasectomized male partner should be the sole partner for that patient. If vasectomy of the male partner is the highly effective method of contraception chosen, the success of the vasectomy should be medically confirmed according to local practice.
Placement of an intrauterine device (IUD). Notes:
Use of oral (estrogen and progesterone), transdermal, injected, implanted, hormone containing intrauterine system or any other hormonal method of contraception is not allowed in this trial.
Women are considered of CBP unless: they have had ≥ 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks prior to randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment she is considered not of CBP.
After the end of trial treatment, patients should use effective contraception according to local guidelines.
Exclusion Criteria
Inclusion Criteria 1. Signed and dated Patient Informed Consent Form (PICF) obtained prior to any trial-specific screening procedure. 2. Patient is ≥ 18 years-old at the time of PICF signature. 3. Patient is female with known menopausal status at the time of randomization or initiation of adjuvant ET (whichever occurs earlier), or male. Postmenopausal status is defined as:
Patient underwent bilateral oophorectomy, or
Age ≥ 60 years, or
Age \< 60 years and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene or ovarian suppression) and Follicle-stimulating hormone (FSH) and plasma estradiol are in the postmenopausal ranges per local normal ranges.
If taking tamoxifen or toremifene and age \<60 years, then FSH and plasma estradiol level in postmenopausal ranges. Notes
In women who are premenopausal at the beginning of adjuvant chemotherapy, amenorrhea is not a reliable indicator of menopausal status as ovarian function may still be intact or resume despite anovulation/amenorrhea. For these women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol per local clinical guidelines are required for determination of postmenopausal status.
All women who do not meet the criteria for postmenopausal status are considered premenopausal for the purpose of this trial. 4. Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis (i.e. date of the pathology report that confirmed the BC diagnosis) within 18 months prior to randomization. Patient with a multicentric and/or multifocal tumor is eligible if all histopathologically examined lesions meet the pathologic criteria in inclusion criteria 5 and 6. 5. Patient has breast cancer that is positive for ER and/or PgR according to the local laboratory as determined on the most recently analyzed tissue sample. 6. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the HER2-negative status (based on the most recently analyzed tissue sample tested by a local laboratory). 7. Patient (except those enrolled in China) has available archival tumor tissue from the surgical specimen, for submission to a central laboratory (Note: in patients that underwent neoadjuvant systemic therapy and had a pathologic complete response, archival tumor tissue at the time of the initial diagnosis or before the administration of neoadjuvant therapy is mandatory). 8. Patient, after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:
Anatomic Stage Group III, or
Anatomic Stage Group IIB, or
Anatomic Stage Group IIA (subset) Notes:
For patients whose tumors are Anatomic Stage IIA, N0:
If Grade is 1 or unknown (Gx), patient is not eligible.
If Grade 2, the gene expression test results (by Oncotype DX, Prosigna/PAM50, MammaPrint or EndoPredict EPclin) or Ki67 levels should be used if obtained as per local practice (i.e. are not mandatory for the purpose of the trial). Results must be available at screening.
Patients that received neoadjuvant treatment must meet the above criteria (for stage, and if Stage IIA, N0, also for grade and Ki67 or gene expression test) in any presurgical staging/sample and/or in the surgical specimen.
Categorization into the AJCC 8th edition Anatomic Stage Groups requires determination of the T, N and M categories. ALND is the preferred method for axillary lymph node staging, however SLN dissection can be used to determine the N category in the following cases:
No metastasis in SLN (patient is considered as pN0).
Only micrometastasis in SLN (patient is considered as pN1mi).
Patients with T1-2 and no clinically-evident nodes prior to surgery, no neoadjuvant chemotherapy, at least one macrometastasis in 1 or 2 SLNs, no matted nodes or gross extranodal disease at the time of SLN dissection (patient is considered as pN1). In all other cases, ALND is required to determine the N category. 9. If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according to the institutional guidelines, prior to screening. 10. If indicated, patient has completed adjuvant radiotherapy according to the institutional guidelines, prior to screening. 11. Patient has no contraindication for the adjuvant ET in the trial and is planned to be treated with ET for 5 years (since randomization date) or more. 12. Patient may have already received any standard neoadjuvant and/or adjuvant ET at the time of PICF signature, but randomization should occur within 12 months of the initial start date of ET. Ovarian suppression or short term ET for fertility preservation is not considered neoadjuvant/adjuvant ET. If patient was receiving tamoxifen or toremifene as adjuvant ET, a washout period of 5 half-lives (i.e. 35 days) prior to randomization is required (during that period patient can take AI). 13. Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 14. Patient has adequate bone marrow and organ function as defined by the following local laboratory values:
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
Platelets ≥ 100 × 109/L
Hemoglobin ≥ 9.0 g/dL
Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m2 according to the Modification of Diet in Renal Disease (MDRD) formula
Alanine transaminase (ALT) \< 2.5 × Upper Limit Normal (ULN)
Aspartate transaminase (AST) \< 2.5 × ULN
Total serum bilirubin \< ULN; or total bilirubin ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN in patients with well documented Gilbert's Syndrome
International normalized ratio (INR) ≤ 1.5 (unless the patient is receiving anticoagulants and the INR is within the therapeutic range of intended use for that anticoagulant within 7 days prior to randomization)
Patient must have the following laboratory values within normal limits or corrected to within normal limits with supplements (the local laboratory value should be documented within normal limits after the correction) before randomization:
Potassium
Magnesium
Total Calcium (corrected for serum albumin) 15. Standard 12-lead ECG values assessed by a central laboratory, as:
QTcF interval (QT interval using Fridericia's correction) at screening \< 450 milliseconds (msec)
Resting heart rate 50-90 beats per minute (determined from the ECG) 16. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures. 17. Women of childbearing potential (CBP), defined as all women physiologically capable of becoming pregnant (see Inclusion Criterion #18 for additional information), must have confirmed negative serum pregnancy test (for β-hCG) within 14 days prior to randomization. 18. Women of CBP must be willing to use highly effective methods of contraception. Contraception must continue during the trial treatment and for 21 days after stopping the treatment. Highly effective contraception methods include:
Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before taking trial treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
Male partner sterilization (at least 6 months prior to randomization). For female patients on the trial the vasectomized male partner should be the sole partner for that patient. If vasectomy of the male partner is the highly effective method of contraception chosen, the success of the vasectomy should be medically confirmed according to local practice.
Placement of an intrauterine device (IUD). Notes:
Use of oral (estrogen and progesterone), transdermal, injected, implanted, hormone containing intrauterine system or any other hormonal method of contraception is not allowed in this trial.
Women are considered of CBP unless: they have had ≥ 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks prior to randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment she is considered not of CBP.
After the end of trial treatment, patients should use effective contraception according to local guidelines. Exclusion Criteria 1. Patient has received any CDK4/6 inhibitor. 2. Patient has received prior treatment with tamoxifen, raloxifene or AIs for reduction in risk ("chemoprevention") of breast cancer and/or treatment for osteoporosis within the last 2 years prior to randomization. Patient is concurrently using hormone replacement therapy. 3. Patient has received prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin. 4. Patient with a known hypersensitivity to any of the excipients of ribociclib and/or ET (e.g. rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption, and soy allergy). 5. Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery. 6. Patient is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET (see Inclusion Criterion #12). 7. Patient has had major surgery, chemotherapy or radiotherapy within 14 days prior to randomization. 8. Patient has not recovered from clinical and laboratory acute toxicities related to prior anti-cancer therapies to a NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 4.03 Grade ≤1 at day of randomization. Exceptions to this criterion: patients with any grade of alopecia, amenorrhea, grade 2 neuropathy are allowed to enter the trial or other toxicities not considered a safety risk for the patient as per Investigator's discretion, are allowed to enter the trial. 9. Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 2 years before randomization. Note: Patients with adequately treated, basal or squamous cell skin carcinoma or curatively resected cervical cancer in situ are eligible. 10. Patient has known history of human immunodeficiency virus (HIV) infection (testing is not mandatory, unless required by local regulation). 11. Patient has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (testing is not mandatory, unless required by local regulation). 12. Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following:
History of documented myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft within 6 months prior to trial entry.
Documented cardiomyopathy.
Left Ventricular Ejection Fraction (LVEF) \< 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) (testing not mandatory)
Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
Risk factors for Torsades de Pointes (TdP) including uncorrected hypocalcemia, hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
Concomitant medication(s) with a known risk to prolong the QT interval and/or known to cause TdP that cannot be discontinued or replaced by safe alternative medication (e.g. within 5 half-lives or 7 days prior to starting trial treatment).
Inability to determine the QTcF interval.
Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, high-grade Atrioventricular (AV) block (e.g. bifascicular block, Mobitz type II and third degree AV block).
Uncontrolled arterial hypertension with systolic blood pressure \> 160 mmHg. 13. Patient is currently receiving any of the following substances within 7 days before randomization:
Concomitant medications, herbal supplements, and/or fruits (e.g. grapefruit, pummellos, starfruit, Seville oranges) and their juices that are known as strong inhibitors or inducers of CYP3A4/5
Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5 14. Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting trial treatment, or has not fully recovered from side effects of such treatment. Note: The following uses of corticosteroids are permitted: a short duration (\<5 days) of systemic corticosteroids; any duration of topical applications (e.g. for rash), inhaled sprays (e.g. for obstructive airways diseases), eye drops or local injections (e.g. intra-articular). 15. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the oral trial treatments (e.g. uncontrolled ulcerative diseases, uncontrolled nausea, vomiting or diarrhea, malabsorption syndrome, or small bowel resection). 16. Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, liver cirrhosis or any other significant liver disease, active untreated or uncontrolled fungal, bacterial or viral infections, active infection requiring systemic anti-bacterial therapy, etc.) or limit life expectancy to ≤5 years. 17. Participation in other studies involving investigational drug(s) within 30 days prior to randomization or within 5 half-lives of the investigational drug(s) (whichever is longer), or participation in any other type of medical research judged not to be scientifically or medically compatible with this trial. If the patient is enrolled or planned to be enrolled in another study that does not involve an investigational drug, the agreement of the Medical Monitor is required to establish eligibility. 18. Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.

Contacts and Locations

Sponsors and CollaboratorsNovartis Pharmaceuticals
Locations
University of Alabama at Birmingham-Kirklin Clinic | Birmingham Alabama, United States, 35294-0006Cancer Treatment Centers of America | Goodyear Arizona, United States, 85338St Bernards Medical Center | Jonesboro Arkansas, United States, 72401Comprehensive Blood and Cancer | Bakersfield California, United States, 93309UCLA Beverly Hills | Beverly Hills California, United States, 90212UCLA Burbank | Burbank California, United States, 91505Encino Research Center | Encino California, United States, 91436St. Jude Heritage Medical Group | Fullerton California, United States, 92835UCLA Hematology Oncology | Laguna Hills California, United States, 92653Southern CA Oncology Rsrch Alliance | Los Angeles California, United States, 90057Stanford University Medical Center | Palo Alto California, United States, 94304-1509UCLA Pasadena HC Hemato Onco | Pasadena California, United States, 941105UCLA Porter Ranch Hemato and Onco | Porter Ranch California, United States, 91326Cancer Care Associates Medical Grp | Redondo Beach California, United States, 90277Sharp Memorial Hospital | San Diego California, United States, 92123UCSF | San Francisco California, United States, 94115Central Coast Medical Oncology Corporation | Santa Maria California, United States, 93454UCLA Santa Monica Hematology Oncology | Santa Monica California, United States, 90404Lundquist Inst BioMed at Harbor | Torrance California, United States, 90509-2910UCLA Valencia | Valencia California, United States, 91355Valley Breast Care | Van Nuys California, United States, 91405UCLA Cancer Center Westlake Village | Westlake Village California, United States, 91361University Of Colorado Hospital | Aurora Colorado, United States, 80045Rocky Mountain Cancer Centers | Denver Colorado, United States, 80218Hospital of Central Connecticut | New Britain Connecticut, United States, 06052Yale University School Of Medicine | New Haven Connecticut, United States, 06520Norwalk Hospital | Norwalk Connecticut, United States, 06856Eastern Connecticut Hematology and Oncology Associates | Norwich Connecticut, United States, 06360Holy Cross Hospital-Ft. Lauderdale | Fort Lauderdale Florida, United States, 33308Florida Cancer Specialists | Fort Myers Florida, United States, 33901Memorial Cancer Institute | Hollywood Florida, United States, 33021Baptist MD Anderson Cancer Center | Jacksonville Florida, United States, 32207University of Miami | Miami Florida, United States, 33136Orlando Health Clinical Trials | Orlando Florida, United States, 32806Florida Cancer Specialists-North | St. Petersburg Florida, United States, 33705Florida Cancer Specialists Pan | Tallahassee Florida, United States, 32308Florida Cancer Specialists | West Palm Beach Florida, United States, 33401Winship Cancer Institute of Emory University | Atlanta Georgia, United States, 30322Southeastern Regional Medical Center | Newnan Georgia, United States, 30265Cancer Treatment Centers of America | Zion Illinois, United States, 60099Cancer Care Center | New Albany Indiana, United States, 47150University of Kansas Cancer Center | Westwood Kansas, United States, 66205Cancer Center of Kansas | Wichita Kansas, United States, 67214-3728Norton Cancer Institute | Louisville Kentucky, United States, 40202Mercy Medical Center | Baltimore Maryland, United States, 21202Massachusetts General Hospital | Boston Massachusetts, United States, 02114University of Michigan Cancer Center | Ann Arbor Michigan, United States, 48109Fairview Health Services | Maple Grove Minnesota, United States, 55369Metro Minnesota CCOP | Saint Louis Park Minnesota, United States, 55416Park Nicollet Institute | Saint Louis Park Minnesota, United States, 55416Saint Lukes Hospital of Kansas City | Kansas City Missouri, United States, 64111HCA Midwest Division | Kansas City Missouri, United States, 64132David C Pratt Cancer Center | St Louis Missouri, United States, 63141St Vincent Frontier Cancer Center | Billings Montana, United States, 59102Saint Francis Medical Center | Grand Island Nebraska, United States, 68803Comprehensive Cancer Cntr Of Nevada | Henderson Nevada, United States, 89052Saint Barnabas Medical Center | Livingston New Jersey, United States, 07039Perlmutter Cancer Centre | New York New York, United States, 10016Randolph Medical Associates | Asheboro North Carolina, United States, 27204Cone Health Cancer Center | Greensboro North Carolina, United States, 27403Kaiser Permanente NW Region | Clackamas Oregon, United States, 97015Penn State Hershey Cancer Institute | Hershey Pennsylvania, United States, 17033Cancer Treatment Centers of America Eastern Regional Medical Center | Philadelphia Pennsylvania, United States, 19124The West Clinic | Germantown Tennessee, United States, 38138Sarah Cannon Research Institute | Nashville Tennessee, United States, 37203Baylor Charles A Sammons Cancer Cnt | Dallas Texas, United States, 75246Ctr For Cancer And Blood Disorders | Fort Worth Texas, United States, 76104MD Anderson Cancer Center University of Texas | Houston Texas, United States, 77030Utah Cancer Specialists | Salt Lake City Utah, United States, 84106Virginia Cancer Specialists | Fairfax Virginia, United States, 22031Virginia Cancer Institute | Richmond Virginia, United States, 23230Fred Hutchinson Cancer Center | Seattle Washington, United States, 98109University of Wisconsin Paul P Carbone Comp Cancer Center | Madison Wisconsin, United States, 53792 6164Novartis Investigative Site | San Salvador de Jujuy Jujuy Province, Argentina, 4600Novartis Investigative Site | Rosario Santa Fe Province, Argentina, S2000Novartis Investigative Site | Rosario Sante Fe, Argentina, S200KZENovartis Investigative Site | San Miguel Tucuman Tucumán Province, Argentina, T4000IAKNovartis Investigative Site | Rio Negro Viedma, Argentina, 8500Novartis Investigative Site | CABA , Argentina, C1419AHNNovartis Investigative Site | Córdoba , Argentina, X5004FHPNovartis Investigative Site | La Rioja , Argentina, 5300Novartis Investigative Site | Campbelltown New South Wales, Australia, 2560Novartis Investigative Site | Coffs Harbour New South Wales, Australia, 2450Novartis Investigative Site | Darlinghurst New South Wales, Australia, 2010Novartis Investigative Site | Kingswood New South Wales, Australia, 2747Novartis Investigative Site | Kogarah New South Wales, Australia, 2217Novartis Investigative Site | North Ryde New South Wales, Australia, 2109Novartis Investigative Site | St Leonards New South Wales, Australia, 2065Novartis Investigative Site | Wahroonga New South Wales, Australia, 2076Novartis Investigative Site | Westmead New South Wales, Australia, 2145Novartis Investigative Site | Auchenflower Queensland, Australia, 4066Novartis Investigative Site | Birtinya Queensland, Australia, 4575Novartis Investigative Site | Wooloongabba Queensland, Australia, 4102Novartis Investigative Site | Bedford Park South Australia, Australia, 5041Novartis Investigative Site | Bendigo Victoria, Australia, 3550Novartis Investigative Site | East Melbourne Victoria, Australia, 3002Novartis Investigative Site | Epping Victoria, Australia, 3076Novartis Investigative Site | Fitzroy Victoria, Australia, 3065Novartis Investigative Site | Franston Victoria, Australia, 3199Novartis Investigative Site | Heidelberg Victoria, Australia, 3084Novartis Investigative Site | Melbourne Victoria, Australia, 3000Novartis Investigative Site | Shepparton Victoria, Australia, 3630Novartis Investigative Site | Murdoch Western Australia, Australia, 6150Novartis Investigative Site | Nedlands Western Australia, Australia, 6009Novartis Investigative Site | Liverpool , Australia, 2170Novartis Investigative Site | Innsbruck Tyrol, Austria, 6020Novartis Investigative Site | Graz , Austria, 8036Novartis Investigative Site | Linz , Austria, 4020Novartis Investigative Site | Salzburg , Austria, 5020Novartis Investigative Site | Vienna , Austria, 1090Novartis Investigative Site | Hasselt Limburg, Belgium, 3500Novartis Investigative Site | Leuven Vlaams Brabant, Belgium, 3000Novartis Investigative Site | Brussels , Belgium, 1000Novartis Investigative Site | Brussels , Belgium, 1200Novartis Investigative Site | Charleroi , Belgium, 6000Novartis Investigative Site | Edegem , Belgium, 2650Novartis Investigative Site | Jette , Belgium, 1090Novartis Investigative Site | Libramont , Belgium, 6800Novartis Investigative Site | Liège , Belgium, 4000Novartis Investigative Site | Namur , Belgium, 5000Novartis Investigative Site | Wilrijk , Belgium, 2610Novartis Investigative Site | Yvoir , Belgium, 5530Novartis Investigative Site | Londrina Paraná, Brazil, 86015-520Novartis Investigative Site | Ijuí Rio Grande do Sul, Brazil, 98700-000Novartis Investigative Site | Porto Alegre Rio Grande do Sul, Brazil, 90035-903Novartis Investigative Site | Porto Alegre Rio Grande do Sul, Brazil, 90050-170Novartis Investigative Site | Porto Alegre Rio Grande do Sul, Brazil, 90560-030Novartis Investigative Site | Porto Alegre Rio Grande do Sul, Brazil, 90610-000Novartis Investigative Site | Porto Alegre Rio Grande do Sul, Brazil, 90880-480Novartis Investigative Site | Barretos São Paulo, Brazil, 14784 400Novartis Investigative Site | Santo André São Paulo, Brazil, 09060-650Novartis Investigative Site | São Paulo São Paulo, Brazil, 01317 000Novartis Investigative Site | São Paulo São Paulo, Brazil, 04014-002Novartis Investigative Site | Caxias do Sul , Brazil, 95070-560Novartis Investigative Site | Passo Fundo , Brazil, 99010-080Novartis Investigative Site | Piracicaba , Brazil, 13419-155Novartis Investigative Site | Recife , Brazil, 50040-000Novartis Investigative Site | Rio de Janeiro , Brazil, 20560-120Novartis Investigative Site | Salvador , Brazil, 41810 570Novartis Investigative Site | São Paulo , Brazil, 01255-000Novartis Investigative Site | Calgary Alberta, Canada, T2N4N2Novartis Investigative Site | Edmonton Alberta, Canada, T6G 1Z2Novartis Investigative Site | Kelowna British Columbia, Canada, V1Y 5L3Novartis Investigative Site | North Vancouver British Columbia, Canada, V7L 2L7Novartis Investigative Site | Surrey British Columbia, Canada, V3V 1Z2Novartis Investigative Site | Vancouver British Columbia, Canada, V5Z 4E6Novartis Investigative Site | Halifax Nova Scotia, Canada, B3H 2Y9Novartis Investigative Site | Greater Sudbury Ontario, Canada, P3E 5J1Novartis Investigative Site | Kitchener Ontario, Canada, N2G 1G3Novartis Investigative Site | London Ontario, Canada, N6A 5W9Novartis Investigative Site | Newmarket Ontario, Canada, J7Y 2P9Novartis Investigative Site | Oshawa Ontario, Canada, L1G 2B9Novartis Investigative Site | Sault Ste. Marie Ontario, Canada, P6B 0A8Novartis Investigative Site | Toronto Ontario, Canada, M4N 3M5Novartis Investigative Site | Toronto Ontario, Canada, M5G 2M9Novartis Investigative Site | Windsor Ontario, Canada, N8W 2X3Novartis Investigative Site | Fleurimont Quebec, Canada, J1H 5N4Novartis Investigative Site | Greenfield Park Quebec, Canada, J4V 2H1Novartis Investigative Site | Montreal Quebec, Canada, H2W 1T8Novartis Investigative Site | Montreal Quebec, Canada, H3T 1E2Novartis Investigative Site | Montreal Quebec, Canada, H4A 3J1Novartis Investigative Site | Québec Quebec, Canada, G1S 4L8Novartis Investigative Site | Saint-Jérôme Quebec, Canada, J7Z 5T3Novartis Investigative Site | Guangzhou Guangdong, China, 510000Novartis Investigative Site | Shijiazhuang Hebei, China, 050011Novartis Investigative Site | Harbin Heilongjiang, China, 150081Novartis Investigative Site | Zhengzhou Henan, China, 450008Novartis Investigative Site | Wuhan Hubei, China, 430022Novartis Investigative Site | Nanjing Jiangsu, China, 210029Novartis Investigative Site | Suzhou Jiangsu, China, 215004Novartis Investigative Site | Changchun Jilin, China, 130021Novartis Investigative Site | Chengdu Sichuan, China, 610041Novartis Investigative Site | Hangzhou Zhejiang, China, 310016Novartis Investigative Site | Beijing , China, 100021Novartis Investigative Site | Chongqing , China, 400016Novartis Investigative Site | Shanghai , China, 200032Novartis Investigative Site | Tianjin , China, 300480Novartis Investigative Site | Zhenjiang , China, 310009Novartis Investigative Site | Nice Alpes Maritimes, France, 06189Novartis Investigative Site | Dijon Cote D Or, France, 21034Novartis Investigative Site | Limoges Haute Vienne, France, 87000Novartis Investigative Site | Saint-Cloud Hauts De Seine, France, 92210Novartis Investigative Site | Rennes Ille Et Vilaine, France, 35062Novartis Investigative Site | Grenoble Isere, France, 38028Novartis Investigative Site | Lyon Rhone, France, 69004Novartis Investigative Site | Amiens , France, 80000Novartis Investigative Site | Angers , France, 49055Novartis Investigative Site | Argenteuil , France, 95107Novartis Investigative Site | Avignon , France, 84082Novartis Investigative Site | Besançon , France, 25030Novartis Investigative Site | Bordeaux , France, 33076Novartis Investigative Site | Bron , France, 69677Novartis Investigative Site | Caen , France, 14021Novartis Investigative Site | Le Mans , France, 72000Novartis Investigative Site | Marseille , France, 13008Novartis Investigative Site | Montpellier , France, 34070Novartis Investigative Site | Montpellier , France, 34298Novartis Investigative Site | Nantes , France, 44202Novartis Investigative Site | Paris , France, 75013Novartis Investigative Site | Paris , France, 75015Novartis Investigative Site | Paris , France, 75231Novartis Investigative Site | Paris , France, 75475Novartis Investigative Site | Paris , France, 75970Novartis Investigative Site | Pierre-Bénite , France, 69495Novartis Investigative Site | Rouen , France, 76038Novartis Investigative Site | Saint-Herblain , France, 44805Novartis Investigative Site | Strasbourg , France, F 67085Novartis Investigative Site | Toulouse , France, 31059Novartis Investigative Site | Vandœuvre-lès-Nancy , France, 54519Novartis Investigative Site | Villejuif , France, 94800Novartis Investigative Site | Ravensburg Baden-Wurttemberg, Germany, 88212Novartis Investigative Site | Munich Bavaria, Germany, 80637Novartis Investigative Site | Munich Bavaria, Germany, 81377Novartis Investigative Site | Munich Bavaria, Germany, 81675Novartis Investigative Site | Würzburg Bavaria, Germany, 97080Novartis Investigative Site | Cottbus Brandenburg, Germany, 03048Novartis Investigative Site | Frankfurt am Main Hesse, Germany, 60431Novartis Investigative Site | Georgsmarienhütte Lower Saxony, Germany, 49124Novartis Investigative Site | Hanover Lower Saxony, Germany, 30177Novartis Investigative Site | Essen North Rhine-Westphalia, Germany, 45136Novartis Investigative Site | Mönchengladbach North Rhine-Westphalia, Germany, 41061Novartis Investigative Site | Velbert North Rhine-Westphalia, Germany, 42551Novartis Investigative Site | Dresden Saxony, Germany, 01307Novartis Investigative Site | Augsburg , Germany, 86150Novartis Investigative Site | Bad Liebenwerda , Germany, 04924Novartis Investigative Site | Berlin , Germany, 13125Novartis Investigative Site | Bonn , Germany, 53111Novartis Investigative Site | Bottrop , Germany, 46236Novartis Investigative Site | Erlangen , Germany, 91054Novartis Investigative Site | Essen , Germany, 45147Novartis Investigative Site | Hamburg , Germany, 20357Novartis Investigative Site | Kiel , Germany, 24105Novartis Investigative Site | Mainz , Germany, 55131Novartis Investigative Site | Mannheim , Germany, 68167Novartis Investigative Site | Münster , Germany, 48149Novartis Investigative Site | Regensburg , Germany, 93053Novartis Investigative Site | Schweinfurt , Germany, 97422Novartis Investigative Site | Tübingen , Germany, 72076Novartis Investigative Site | Ulm , Germany, 89081Novartis Investigative Site | Pécs Baranya, Hungary, 7623Novartis Investigative Site | Debrecen Hajdu Bihar Megye, Hungary, 4032Novartis Investigative Site | Zalaegerszeg Zala County, Hungary, 8900Novartis Investigative Site | Budapest , Hungary, H-1032Novartis Investigative Site | Budapest , Hungary, H-1083Novartis Investigative Site | Budapest , Hungary, H-1145Novartis Investigative Site | Kecskemét , Hungary, 6001Novartis Investigative Site | Szeged , Hungary, 6725Novartis Investigative Site | Szekszárd , Hungary, 7100Novartis Investigative Site | Szombathely , Hungary, H-9700Novartis Investigative Site | Tatabánya , Hungary, H 2800Novartis Investigative Site | Wilton Cork, Ireland, T12 DC4ANovartis Investigative Site | County Limerick , Ireland, V94 F858Novartis Investigative Site | Dublin , Ireland, 533615Novartis Investigative Site | Dublin , Ireland, D03 VX82Novartis Investigative Site | Dublin , Ireland, DO4Novartis Investigative Site | Dublin , Ireland, DUBLIN 9Novartis Investigative Site | Waterford , Ireland, 48346Novartis Investigative Site | Ancona AN, Italy, 60126Novartis Investigative Site | Bergamo BG, Italy, 24127Novartis Investigative Site | Bologna BO, Italy, 40138Novartis Investigative Site | Catania CT, Italy, 95123Novartis Investigative Site | Milan MI, Italy, 20133Novartis Investigative Site | Rozzano MI, Italy, 20089Novartis Investigative Site | Palermo PA, Italy, 90146Novartis Investigative Site | Aviano PN, Italy, 33081Novartis Investigative Site | Roma RM, Italy, 00128Novartis Investigative Site | Candiolo TO, Italy, 10060Novartis Investigative Site | Naples , Italy, 80131Novartis Investigative Site | Warsaw Ul Roentgena 5, Poland, 02 781Novartis Investigative Site | Bialystok , Poland, 15-027Novartis Investigative Site | Gdynia , Poland, 81 519Novartis Investigative Site | Gliwice , Poland, 44 101Novartis Investigative Site | Grudziądz , Poland, 86 300Novartis Investigative Site | Krakow , Poland, 31501Novartis Investigative Site | Lodz , Poland, 90-338Novartis Investigative Site | Lublin , Poland, 20 090Novartis Investigative Site | Opole , Poland, 45 054Novartis Investigative Site | Ostrołęka , Poland, 07-410Novartis Investigative Site | Otwock , Poland, 05 400Novartis Investigative Site | Wieliszew , Poland, 05-135Novartis Investigative Site | Wroclaw , Poland, 02-781Novartis Investigative Site | Cluj-Napoca Cluj, Romania, 400015Novartis Investigative Site | Craiova Dolj, Romania, 200347Novartis Investigative Site | Craiova Dolj, Romania, 200535Novartis Investigative Site | Bucharest , Romania, 011171Novartis Investigative Site | Timișoara , Romania, 300425Novartis Investigative Site | Kazan' Russian Federation, Russia, 420029Novartis Investigative Site | Saint Petersburg Sankt-Peterburg, Russia, 195271Novartis Investigative Site | Chelyabinsk , Russia, 454087Novartis Investigative Site | Kostroma , Russia, 156005Novartis Investigative Site | Krasnoyarsk , Russia, 660022Novartis Investigative Site | Moscow , Russia, 111123Novartis Investigative Site | Moscow , Russia, 115522Novartis Investigative Site | Moscow , Russia, 143423Novartis Investigative Site | Nizhny Novgorod , Russia, 603137Novartis Investigative Site | Novosibirsk , Russia, 630000Novartis Investigative Site | Obninsk , Russia, 249036Novartis Investigative Site | Omsk , Russia, 644013Novartis Investigative Site | Orenburg , Russia, 460021Novartis Investigative Site | Rostov-on-Don , Russia, 344037Novartis Investigative Site | Ryazan , Russia, 390011Novartis Investigative Site | Saint Petersburg , Russia, 191104Novartis Investigative Site | Saint Petersburg , Russia, 197758Novartis Investigative Site | Saint Petersburg , Russia, 198255Novartis Investigative Site | Tyumen , Russia, 625041Novartis Investigative Site | Ufa , Russia, 450054Novartis Investigative Site | Yaroslavl , Russia, 150054Novartis Investigative Site | Seoul Daegu, South Korea, 41404Novartis Investigative Site | Wŏnju Gangwon-do, South Korea, 26426Novartis Investigative Site | Bundang Gu Gyeonggi-do, South Korea, 13620Novartis Investigative Site | Suwon Gyeonggi-do, South Korea, 16499Novartis Investigative Site | Gyeonggi-do Korea, South Korea, 10408Novartis Investigative Site | Incheon Korea, South Korea, 405 760Novartis Investigative Site | Seoul Korea, South Korea, 02841Novartis Investigative Site | Seoul Korea, South Korea, 03080Novartis Investigative Site | Cheongju-si North Chungcheong, South Korea, 28644Novartis Investigative Site | Seoul Yangcheon Gu, South Korea, 07985Novartis Investigative Site | Incheon , South Korea, 22332Novartis Investigative Site | Seongnam Gyeonggi , South Korea, 463-712Novartis Investigative Site | Seoul , South Korea, 03722Novartis Investigative Site | Seoul , South Korea, 05505Novartis Investigative Site | Seoul , South Korea, 06351Novartis Investigative Site | Seoul , South Korea, 06591Novartis Investigative Site | Ulsan , South Korea, 44033Novartis Investigative Site | Elche Alicante, Spain, 03203Novartis Investigative Site | Granada Andalusia, Spain, 18014Novartis Investigative Site | Huelva Andalusia, Spain, 21005Novartis Investigative Site | Jaén Andalusia, Spain, 23007Novartis Investigative Site | Vitoria-Gasteiz Araba, Spain, 01009Novartis Investigative Site | Badalona Barcelona, Spain, 08916Novartis Investigative Site | L'Hospitalet de Llobregat Barcelona, Spain, 08907Novartis Investigative Site | Manresa Barcelona, Spain, 08242Novartis Investigative Site | Sabadell Barcelona, Spain, 08208Novartis Investigative Site | Bilbao Bizkaia, Spain, 48013Novartis Investigative Site | Badajoz Extremadura, Spain, 06080Novartis Investigative Site | Cáceres Extremadura, Spain, 10003Novartis Investigative Site | Lugo Galicia, Spain, 27003Novartis Investigative Site | Donostia / San Sebastian Gipuzkoa, Spain, 20014Novartis Investigative Site | Fuenlabrada Madrid, Spain, 28942Novartis Investigative Site | Majadahonda Madrid, Spain, 28222Novartis Investigative Site | El Palmar Murcia, Spain, 30120Novartis Investigative Site | Pamplona Navarre, Spain, 31008Novartis Investigative Site | Vigo Pontevedra, Spain, 36212Novartis Investigative Site | San Cristóbal de La Laguna Santa Cruz De Tenerife, Spain, 38320Novartis Investigative Site | Alicante Valencia, Spain, 03550Novartis Investigative Site | Valencia Valencia, Spain, 46009Novartis Investigative Site | A Coruña , Spain, 15006Novartis Investigative Site | A Coruña , Spain, 15009Novartis Investigative Site | Barcelona , Spain, 08035Novartis Investigative Site | Barcelona , Spain, 08036Novartis Investigative Site | Burgos , Spain, 09006Novartis Investigative Site | Castellon , Spain, 12002Novartis Investigative Site | Córdoba , Spain, 14004Novartis Investigative Site | Girona , Spain, 17007Novartis Investigative Site | Granada , Spain, 18016Novartis Investigative Site | Las Palmas GC , Spain, 35010Novartis Investigative Site | Madrid , Spain, 28009Novartis Investigative Site | Madrid , Spain, 28033Novartis Investigative Site | Madrid , Spain, 28034Novartis Investigative Site | Madrid , Spain, 28040Novartis Investigative Site | Málaga , Spain, 29010Novartis Investigative Site | Murcia , Spain, 30008Novartis Investigative Site | Salamanca , Spain, 37007Novartis Investigative Site | Seville , Spain, 41009Novartis Investigative Site | Seville , Spain, 41013Novartis Investigative Site | Valencia , Spain, 46010Novartis Investigative Site | Valencia , Spain, 46014Novartis Investigative Site | Zaragoza , Spain, 50009Novartis Investigative Site | Changhua , Taiwan, 50006Novartis Investigative Site | Taichung , Taiwan, 40447Novartis Investigative Site | Taichung , Taiwan, 407219Novartis Investigative Site | Tainan , Taiwan, 704302Novartis Investigative Site | Taipei , Taiwan, 10002Novartis Investigative Site | Taipei , Taiwan, 103616Novartis Investigative Site | Taipei , Taiwan, 10449Novartis Investigative Site | Taipei , Taiwan, 11217Novartis Investigative Site | Taoyuan , Taiwan, 33305Novartis Investigative Site | Truro Cornwall, United Kingdom, TR1 3LJNovartis Investigative Site | Sutton Surrey, United Kingdom, SM2 5PTNovartis Investigative Site | Cardiff , United Kingdom, CF14 2TLNovartis Investigative Site | London , United Kingdom, NW1 2BUNovartis Investigative Site | London , United Kingdom, SE1 9RTNovartis Investigative Site | London , United Kingdom, SW3 6JJNovartis Investigative Site | Nottingham , United Kingdom, NG5 1PBNovartis Investigative Site | Oxford , United Kingdom, OX3 7LENovartis Investigative Site | Preston , United Kingdom, PR2 9HTNovartis Investigative Site | Stoke-on-Trent , United Kingdom, ST4 6QG
Investigators
Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals