Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy

Recruitment Status
ACTIVE, NOT RECRUITING - HAS RESULTS
(See Contacts and Locations)Verified June 2025 by AstraZeneca
Sponsor
AstraZeneca
Information Provided by (Responsible Party)
AstraZeneca
Clinicaltrials.gov Identifier
NCT01874353
Other Study ID Numbers:
D0816C00002
First Submitted
June 6, 2013
First Posted
June 10, 2013
Results First Posted
September 14, 2017
Last Update Posted
August 2, 2025
Last Verified
June 2025

ClinicalTrials.gov processed this data on July 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Comparison of olaparib against a placebo in patients with ovarian cancer whose cancer has already improved by taking platinum based chemotherapy. The patients must also have a fault in their DNA which codes for the BRCA protein. The BRCA protein helps mend broken DNA in the cells of the body; if this protein doesn't work properly it can increase the chance of getting cancer. The aim of this study is to see whether patients taking olaparib tablets last longer until their cancer gets worse, compared to those taking the placebo tablet. The study is also looking to see if there is an overall improvement to how long the patients survive whilst taking olaparib tablets compared to the placebo tablets; and the quality of their life whilst living with ovarian cancer.

Condition or DiseaseIntervention/Treatment
Platinum SensitiveBRCA MutatedRelapsed Ovarian CancerFollowing Complete or Partial Response to Platinum Based Chemotherapy
Drug: Olaparib 300mg tabletsDrug: Placebo to match olaparib 300mg

Study Design

Study TypeInterventional
Actual Enrollment327 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitlePhase III Randomised, Double Blind, Placebo Controlled Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients With a Complete or Partial Response Following Platinum Based Chemotherapy
Study Start DateSeptember 2, 2013
Actual Primary Completion DateSeptember 18, 2016
Actual Study Completion DateDecember 30, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
Olaparib 300mg tablets
Taken orally twice daily
Drug: Olaparib 300mg tablets
300mg Olaparib or placebo tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator (or as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria). Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.
Placebo tablets
Taken orally twice daily
Drug: Placebo to match olaparib 300mg
300mg Olaparib or placebo tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator (or as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria). Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.

Outcome Measures

Primary Outcome Measures
  1. Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)
    To determine the efficacy by progression free survival (PFS) (using investigator assessment according to modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)) of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.
Secondary Outcome Measures
  1. Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Overall Survival
    To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of overall survival (OS).
  2. Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death
    To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of time to earliest progression by RECIST or CA-125 or death.
  3. Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression
    To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization up to second progression
  4. Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)
    To compare the effects of olaparib maintenance monotherapy compared to placebo on Health-related Quality of Life (HRQoL) as assessed by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.
  5. Efficacy of Olaparib by Time to First Subsequent Therapy or Death (TFST)
    To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to first subsequent therapy or death (TFST).
  6. Efficacy of Olaparib by Time to Second Subsequent Therapy or Death (TSST)
    To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to second subsequent therapy or death (TSST).
  7. Efficacy of Olaparib by Time From Randomization to Study Treatment Discontinuation or Death (TDT)
    To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to study treatment discontinuation or death (TDT).
  8. Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS.
    To assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis).
  9. To Determine the Exposure to Olaparib by Pharmacokinetic Analysis
    To determine the exposure to olaparib in patients receiving olaparib maintenance monotherapy

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersNo
Inclusion Criteria
Patients must be ≥ 18 years of age.
Female patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer.
Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
Patients who have received at least 2 previous lines of platinum containing therapy prior to randomisation For the penultimate chemotherapy course prior to enrolment on the study: • Patient defined as platinum sensitive after this treatment; defined as disease progression greater than 6 months after completion of their last dose of platinum chemotherapy For the last chemotherapy course immediately prior to randomisation on the study:
Patients must be, in the opinion of the investigator, in response (partial or complete radiological response), or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy), and no evidence of a rising CA-125, following completion of this chemotherapy course
Patient must have received a platinum based chemotherapy regimen (e.g. carboplatin or cisplatin) and have received at least 4 cycles of treatment
Patients must be randomized within 8 weeks of their last dose of chemotherapy
Maintenance treatment is allowed at the end of the penultimate platinum regimen, including bevacizumab
Exclusion Criteria
Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
BRCA 1 and/or BRCA2 mutations that are considered to be non detrimental (e.g., "Variants of uncertain clinical significance" or "Variant of unknown significance" or "Variant, favor polymorphism" or "benign polymorphism" etc.)
Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study.

Contacts and Locations

Sponsors and CollaboratorsAstraZeneca
Locations
University of Alabama at Birmingham | Birmingham Alabama, United States, Palo Alto Foundation Medical Group | San Francisco California, United States, University of Colorado | Aurora Colorado, United States, The Hospital of Central Connecticut | New Britain Connecticut, United States, Gynecologic Cancer Center | Orlando Florida, United States, North Shore University | Evanston Illinois, United States, Greater Baltimore Medical Center | Baltimore Maryland, United States, Johns Hopkins | Baltimore Maryland, United States, Dana Farber Cancer Institute | Boston Massachusetts, United States, Massachusetts General Hospital | Boston Massachusetts, United States, MD Anderson at Cooper Cancer Center | Voorhees Township New Jersey, United States, Womens Cancer Care Associates | Albany New York, United States, Winthrop Gynecologic Oncology Associates | Mineola New York, United States, OSU JamesCare at Mill Run | Hilliard Ohio, United States, Henry Joyce Cancer Clinic | Nashville Tennessee, United States, Aurora St Lukes Medical Center | Milwaukee Wisconsin, United States, Mercy Hospital for Women | Heidelberg , Australia, The Royal Womens Hospital | Parkville , Australia, Prince of Wales Hospital | Randwick , Australia, U.Z. Gent | Ghent , Belgium, UZ Leuven Gasthuisberg | Leuven , Belgium, Centro Diagnóstico Barretos | Barretos , Brazil, Centro Regional Integrado de Oncologia | Fortaleza , Brazil, Hospital Araujo Jorge | Goiânia , Brazil, Hospital de Caridade de Ijuí | Ijuí , Brazil, Centro de Novos Tratamentos Itajai | Itajaí , Brazil, Hospital de Clinicas de Porto Alegre | Porto Alegre , Brazil, Irmandade da Santa Casa de Misericordia de Porto Alagre | Porto Alegre , Brazil, Hospital de Base São José do Rio Preto | São José do Rio Preto , Brazil, Centro de Referencia da Saude da Mulher | São Paulo , Brazil, Instituto do Câncer de São Paulo | São Paulo , Brazil, Juravinski Cancer Centre | Hamilton Ontario, Canada, London Health Sciences Centre | London Ontario, Canada, Princess Margaret Cancer Centre | Toronto Ontario, Canada, Sunnybrook Health Sciences Center | Toronto Ontario, Canada, CHUM - Hopital Norte-Dame | Montreal Quebec, Canada, Hotel-Dieu de Quebec | Québec Quebec, Canada, CHUS Site Fleurimont | Sherbrooke Quebec, Canada, Beijing Cancer Hospital | Beijing , China, The Tumor Hospital affiliated to China Medical Science Insti | Beijing , China, 1st Hospital of Jilin university | Changchun , China, Jilin Provincial Cancer Hospital | Changchun , China, Hunan Cancer Hospital | Changsha , China, West China Hospital Affiliated to Sichuan University | Chengdu , China, ChongQing Cancer Hospital | Chongqing , China, Research Site | Guangzhou , China, 510060Women's Hospital, Zhejaing University School of Medicine | Hangzhou , China, The Tumour Hospital of Harbin Medical University | Harbin , China, Zhejiang Cancer Hospital, Huangzhou | Huangzhou , China, JINAN, Qi Lu Hosp. of SD Univ. | Jinan , China, Research Site | Shanghai , China, 200011Shanghai Cancer Hospital of Fudan University | Shanghai , China, The First Affiliated Hospital of Soochow University | Suzhou , China, First affiliated hospital college of XianJiaotong University | Xi'an , China, Institut Bergonie | Bordeaux , France, CAC François Baclesse | Caen , France, 69LYON, C Bérard, Onco | Lyon , France, Centre Catherine de Sienne | Nantes , France, 75PARIS, H Tenon, Onco | Paris , France, Hopital Européen Georges Pompidou | Paris , France, Institut Curie Paris Et Saint Cloud | Paris , France, 69PIERREBE, CH Lyon Sud, | Pierre-Bénite , France, 92STCLOUD, C Huguenin, Onco | Saint-Cloud , France, Institut Claudius Regaud | Toulouse , France, Centre Alexis Vautrin | Vandœuvre-lès-Nancy , France, Institut Gustave Roussy | Villejuif , France, Helios-Kliniken Berlin - Buch | Berlin , Germany, Friedrich-Alexander-Universität Erlangen-Nürnberg | Erlangen , Germany, Klinikum Essen-Mitte,Evang. Huyssens-Stiftung/Knapps gGmbH | Essen , Germany, Johann-Wolfgang Goethe-Universität | Frankfurt , Germany, Medizinische Hochschule Hannover | Hanover , Germany, Universitätsklinikum Schleswig-Holstein | Lübeck , Germany, Klinikum rechts der Isar der Technischen Universität | München , Germany, Onkologie Ravensburg | Ravensburg , Germany, Universitätsklinikum Rostock | Rostock , Germany, Rambam Health Care Campus | Haifa , Israel, Sapir Medical Centre | Kfar Saba , Israel, Tel Hashomer | Ramat Gan , Israel, Istituto Europeo di Oncologia | Milan , Italy, Azienda Ospedaliera Policlinico Di Modena | Modena , Italy, Istituto Nazionale Tumori Fondazione Pascale | Naples , Italy, Istituto Oncologico Veneto Irccs | Padova , Italy, Istituto Regina Elena-Polo Oncologico Ifo | Roma , Italy, Policlinico Universitario A. Gemelli | Roma , Italy, Hyogo Cancer Center | Akashi-shi , Japan, National Cancer Center Hospital | Chūōku , Japan, National Hospital Organization Kyushu Cancer Center | Fukuoka , Japan, Saitama Medical University International Medical Center | Hidaka-shi , Japan, National Hospital Organization Shikoku Cancer Center | Matsuyama , Japan, Niigata University Medical and Dental Hospital | Niigata , Japan, Kindai University Hospital | Osakasayama-shi , Japan, Hokkaido University Hospital | Sapporo , Japan, Shizuoka Cancer Center | Sunto-gun , Japan, Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital | Amsterdam , Netherlands, Maastricht Universitair Medisch Centrum | Maastricht , Netherlands, Universitair Medisch Centrum St. Radboud | Nijmegen , Netherlands, Erasmus Medisch Centrum | Rotterdam , Netherlands, Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna | Grzepnica , Poland, SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii | Olsztyn , Poland, Wojewódzki Szpital Specjalistyczny w Olsztynie | Olsztyn , Poland, Centrum Onkologii Instytut im Marii Sklodowskiej-Curie | Warsaw , Poland, Szpital Specjalistyczny im. Swietej Rodziny SPZOZ | Warsaw , Poland, Chemotherapy Department, Russian Cancer Research Centre | Moscow , Russia, Leningrad Regional Oncology Dispensary | Saint Petersburg , Russia, St.Petersburg City Oncology Dispensary, Dept. Gynecology | Saint Petersburg , Russia, Asan Medical Center | Seoul , South Korea, Gangnam Severance Hospital | Seoul , South Korea, Samsung Medical Center | Seoul , South Korea, Seoul National University Hospital | Seoul , South Korea, Barcelona,H.Clinic i Provincial,Oncología | Barcelona , Spain, Barcelona,H.de la Sta.Creu i S.Pau,Oncología | Barcelona , Spain, Córdoba,H.Reina Sofía,Oncología | Córdoba , Spain, Gerona,H.Josep Trueta,Oncología | Girona , Spain, Madrid, H.C.S.Carlos,Oncología | Madrid , Spain, Madrid,H.12 de Octubre,Oncología | Madrid , Spain, Hospital Provincial de Navarra | Pamplona , Spain, Valencia, IVO, Oncología | Valencia , Spain, Valencia,H.C.U.Valencia,Oncología | Valencia , Spain, City Hospital Birmingham Cancer Trials Team | Birmingham , United Kingdom, Addenbrooke's Hospital | Cambridge , United Kingdom, Arden Cancer Centre | Coventry , United Kingdom, Edinburgh Cancer Research UK Centre | Edinburgh , United Kingdom, Cancer Research UK and UCL Cancer Trials Centre | London , United Kingdom, Royal Marsden Hospital | London , United Kingdom, The Christie NHS Foundation Trust | Manchester , United Kingdom, Royal Marsden Hospital and Institute of Cancer Research | Sutton , United Kingdom,
Investigators
Principal Investigator: Professor E Pujade-Lauraine, MD, PhD, Universite de Paris Descartes, France