Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.
- Conditions
- Newly DiagnosedAdvanced Ovarian CancerFIGO Stage III-IVBRCA MutationComplete ResponsePartial ResponseFirst Line Platinum Chemotherapy
- Interventions
- Registration Number
- NCT01844986
- Lead Sponsor
- AstraZeneca
- Brief Summary
Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.
- Detailed Description
A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients with BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer following First Line Platinum Based Chemotherapy
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 450
- Female patients with newly diagnosed, histologically confirmed, high risk advanced (FIGO stage III - IV) BRCA mutated high grade serous or high grade endometrioid ovarian cancer, primary peritoneal cancer and / or fallopian - tube cancer who have completed first line platinum based chemotherapy (intravenous or intraperitoneal).
- Stage III patients must have had one attempt at optimal debulking surgery (upfront or interval debulking). Stage IV patients must have had either a biopsy and/or upfront or interval debulking surgery.
- 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 completed first line platinum (e.g. carboplatin or cisplatin), containing therapy (intravenous or intraperitoneal) prior to randomisation:
- Patients must have, in the opinion of the investigator, clinical complete response or partial response and have no clinical evidence of disease progression on the post treatment scan or rising CA-125 level, following completion of this chemotherapy course. Patients with stable disease on the post-treatment scan at completion of first line platinum-containing therapy are not eligible for the study.
- Patients must be randomized within 8 weeks of their last dose of chemotherapy
- BRCA1 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 with early stage disease (FIGO Stage I, IIA, IIB or IIC)
- Stable disease or progressive disease on the post-treatment scan or clinical evidence of progression at the end of the patient's first line chemotherapy treatment.
- Patients where more than one debulking surgery has been performed before randomisation to the study. (Patients who, at the time of diagnosis, are deemed to be unresectable and undergo only a biopsy or oophorectomy but then go on to receive chemotherapy and interval debulking surgery are eligible).
- Patients who have previously been diagnosed and treated for earlier stage ovarian, fallopian tube or primary peritoneal cancer.
- Patients who have previously received chemotherapy for any abdominal or pelvic tumour, including treatment for prior diagnosis at an earlier stage for their ovarian, fallopian tube or primary peritoneal cancer. (Patients who have received prior adjuvant chemotherapy for localised breast cancer may be eligible, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease).
- Patients with synchronous primary endometrial cancer unless both of the following criteria are met: 1) stage <2 2) less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3 endometrioid adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with Stage IA grade 1 or 2 endometrioid adenocarcinoma. Patients with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium are not eligible.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo tablets p.o. twice daily Olaparib 300mg tablets Olaparib/placebo tablets p.o 300mg twice daily for up to 3 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity Olaparib tablets p.o. 300mg twice daily Olaparib 300mg tablets Olaparib/placebo tablets p.o 300mg twice daily for up to 3 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018 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 high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy.
- Secondary Outcome Measures
Name Time Method Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Overall Survival Assessed every 4 weeks until treatment discontinues (up to a max of 156 weeks), then as per protocol. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity. 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 overall survival (OS). Reports results of a pre-specified interim analysis; results for final OS analysis (235 OS events) anticipated 2029.
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death CA-125 performed at baseline + every 4 weeks. Radiologic scans performed at baseline + every 12 weeks up to 156 weeks, then every 24 weeks until objective radiological disease progression. DCO:17May2018 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 to earliest progression by RECIST or Cancer Antigen-125 (CA-125) or death
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression Following first progression disease then assessed per local practice every 12 weeks until second progression. 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 randomisation to second progression (PFS2)
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) Questionnaires will be given to the patient at baseline, at Day 29 and then every 12 weeks for 156 weeks, then every 24 weeks or until the data cut off for the PFS analysis, change in TOI over 24 months reported 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 high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to First Subsequent Therapy or Death (TFST) Assessed every 12 weeks following treatment discontinuation. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity. 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 randomisation to first subsequent therapy or death (TFST). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Second Subsequent Therapy or Death (TSST) Assessed every 12 weeks following treatment discontinuation. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity. 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 randomisation to second subsequent therapy or death (TSST). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Study Treatment Discontinuation or Death (TDT) Time elapsed from randomization to study treatment discontinuation or death. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity. 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 randomisation to study treatment discontinuation or death (TDT). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).
Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS Radiologic scans performed at baseline then every 12 weeks for the first 156 weeks, then every 24 weeks thereafter, assessed until disease progression. Analysis of data assessed up to a maximum of 54 months. 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 potential future BRCA mutation assays (gene sequencing and large rearrangement analysis)
Trial Locations
- Locations (175)
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Univ Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Texas Health Science Center of Houston
🇺🇸Houston, Texas, United States
Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, United States
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii
🇵🇱Olsztyn, Poland
Szpital Specjalistyczny im. Swietej Rodziny SPZOZ
🇵🇱Warszawa, Poland
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
National Cancer Center
🇰🇷Goyang-si, Korea, Republic of
Centro de Referencia da Saude da Mulher
🇧🇷São Paulo, Brazil
Wojewódzki Szpital Specjalistyczny w Olsztynie
🇵🇱Olsztyn, Poland
Barcelona,H.Vall d´Hebrón,Oncología
🇪🇸Barcelona, Spain
Córdoba,H.Reina Sofía,Oncología
🇪🇸Córdoba, Spain
Rabin MC
🇮🇱Petach Tikva, Israel
MD Anderson at Cooper Cancer Center
🇺🇸Camden, New Jersey, United States
University Hospital Case Medical Center
🇺🇸Cleveland, Ohio, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Mercy Hospital for Women
🇦🇺Heidelberg, Australia
The University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Advocate Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Womens Cancer Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Hope Women's Cancer Centers
🇺🇸Asheville, North Carolina, United States
Minnesota Oncology Hematology, PA
🇺🇸Edina, Minnesota, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Research Site
🇨🇳Guangzhou, China
St. Luke's University Health Network
🇺🇸Bethlehem, Pennsylvania, United States
Hillcrest Hospital Cancer Center
🇺🇸Mayfield Heights, Ohio, United States
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Centro de Novos Tratamentos Itajai
🇧🇷Itajai, Brazil
Aurora Baycare Medical Center
🇺🇸Green Bay, Wisconsin, United States
The Royal Womens Hospital
🇦🇺Parkville, Australia
1st Hospital of Jilin university
🇨🇳Changchun, China
Istituto Nazionale Per Cura Tumori - Milano
🇮🇹Milano, Italy
CHUM - Hopital Norte-Dame
🇨🇦Montreal, Quebec, Canada
NHO Shikoku Cancer Center
🇯🇵Matsuyama-shi, Japan
Centro Diagnóstico Barretos
🇧🇷Barretos, Brazil
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
Sunnybrook Health Sciences Center
🇨🇦Toronto, Ontario, Canada
Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna
🇵🇱Grzepnica, Poland
Maastricht Universitair Medisch Centrum
🇳🇱Maastricht, Netherlands
Institut Bergonie
🇫🇷Bordeaux, France
NHO Kyushu CC
🇯🇵Fukuoka, Japan
National Cancer Center Hosp
🇯🇵Chuo-ku, Japan
Chaim Sheba Medical Centre
🇮🇱Tel Hashomer, Israel
Chemotherapy Department, Russian Cancer Research Centre
🇷🇺Moscow, Russian Federation
Korea Cancer Center Hospital
🇰🇷Seoul, Korea, Republic of
Istituto Regina Elena-Polo Oncologico Ifo
🇮🇹Roma, Italy
Bari- Istituto Tumori Giovanni Paolo II
🇮🇹Bari, Italy
Hotel-Dieu de Quebec
🇨🇦Quebec, Canada
Niigata Univ. Med. Dent.
🇯🇵Niigata-shi, Japan
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Tel-Aviv Sourkasy Medical Center
🇮🇱Tel-Aviv, Israel
Hyogo CC
🇯🇵Akashi-shi, Japan
Saitama Med. Univ. Int. Med. C
🇯🇵Hidaka-shi, Japan
Policlinico Universitario A. Gemelli
🇮🇹Roma, Italy
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
🇵🇱Warszawa, Poland
Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital
🇳🇱Amsterdam, Netherlands
Istituto Europeo di Oncologia
🇮🇹Milano, Italy
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Cancer Research Institute
🇷🇺Saint Petersburg, Russian Federation
Shizuoka Cancer Center
🇯🇵Sunto-gun, Japan
Udmurtia Republic Clinical Oncology Center
🇷🇺Izhevsk, Russian Federation
Madrid, MD Anderson, Oncología
🇪🇸Madrid, Spain
State Institution of Heath Omsk Regional Oncology Dispensary
🇷🇺Omsk, Russian Federation
Madrid,H.U.La Paz,Oncología
🇪🇸Madrid, Spain
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Valencia, IVO, Oncología
🇪🇸Valencia, Spain
Valencia,H.C.U.Valencia,Oncología
🇪🇸Valencia, Spain
H.Llobregat,ICO-Duran i Reynals,Oncología
🇪🇸Hospitalet deLlobregat(Barcelo, Spain
St. Joseph's Hospital & Medical Center
🇺🇸Phoenix, Arizona, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Peggy and Charles Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
West China Hospital Affiliated to Sichuan University
🇨🇳Chengdu, China
ChongQing Cancer Hospital
🇨🇳Chongqing, China
The Tumour Hospital of Harbin Medical University
🇨🇳Harbin, China
Shanghai Cancer Hospital of Fudan University
🇨🇳Shanghai, China
JINAN, Qi Lu Hosp. of SD Univ.
🇨🇳Ji Nan, China
Beijing Cancer Hospital
🇨🇳Beijing, China
The Tumor Hospital affiliated to China Medical Science Insti
🇨🇳Beijing, China
Azienda Ospedaliera "Cannizzaro"
🇮🇹Catania, Italy
Istituto Nazionale Tumori Fondazione Pascale
🇮🇹Napoli, Italy
Istituto Oncologico Veneto Irccs
🇮🇹Padova, Italy
Hospital Araujo Jorge
🇧🇷Goiânia, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alagre
🇧🇷Porto Alegre, Brazil
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
City Hospital, Birmingham, Cancer Trials Team
🇬🇧Birmingham, United Kingdom
Edinburgh Cancer Research UK Centre
🇬🇧Edinburgh, United Kingdom
Arden Cancer Centre
🇬🇧Coventry, United Kingdom
Royal Marsden Hospital
🇬🇧London, United Kingdom
Hokkaido University Hospital
🇯🇵Sapporo-shi, Japan
Missouri Valley Cancer Consortium CCOP
🇺🇸Omaha, Nebraska, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Mayo Clinic - Rochester, MN
🇺🇸Rochester, Minnesota, United States
Research Institute of Oncology RAMS
🇷🇺Tomsk, Russian Federation
St.Petersburg City Oncology Dispensary, Dept. Gynecology
🇷🇺Saint Petersburg, Russian Federation
Perlmutter Cancer Center
🇺🇸New York, New York, United States
Prince of Wales Hospital
🇦🇺Randwick, Australia
University of Colorado
🇺🇸Aurora, Colorado, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Gynecologic Oncology of West MI, PLLC
🇺🇸Grand Rapids, Michigan, United States
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Providence Cancer Center
🇺🇸Anchorage, Alaska, United States
Clearview Cancer Institute
🇺🇸Huntsville, Alabama, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Stanford Women's Cancer Center
🇺🇸Stanford, California, United States
Kaiser Permanente
🇺🇸Roseville, California, United States
Babak Edraki
🇺🇸Walnut Creek, California, United States
Univ of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
H Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Nancy N. & J.C. Lewis Cancer and Research Pavillion
🇺🇸Savannah, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
St. Vincent Hospital & Health Care Center
🇺🇸Indianapolis, Indiana, United States
Maine Medical Partners
🇺🇸Scarborough, Maine, United States
Northern Indiana Cancer Research Consortium
🇺🇸Mishawaka, Indiana, United States
McFarland Clinic, P.C.
🇺🇸Ames, Iowa, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Women's Cancer Care Associates
🇺🇸Albany, New York, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
John Theurer Cancer Center
🇺🇸Hackensack, New Jersey, United States
Cleveland Clinic Cancer Center at Fairview Hospital
🇺🇸Cleveland, Ohio, United States
Sanford Roger Maris Cancer Center
🇺🇸Fargo, North Dakota, United States
Mount Sinai Medical Center - New York
🇺🇸New York, New York, United States
Aultman Hospital
🇺🇸Canton, Ohio, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Women and Infants Hospital
🇺🇸Providence, Rhode Island, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
South Carolina Oncology Associates, PA
🇺🇸Columbia, South Carolina, United States
Froedtert Memorial Hospital
🇺🇸Milwaukee, Wisconsin, United States
Sanford Clinic Women's Health
🇺🇸Sioux Falls, South Dakota, United States
Carilion Clinic Gynecological Oncology
🇺🇸Roanoke, Virginia, United States
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Brazil
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Instituto do Câncer de São Paulo
🇧🇷São Paulo, Brazil
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Hospital de Base São José do Rio Preto
🇧🇷São José do Rio Preto, Brazil
Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Jilin Provincial Cancer Hospital
🇨🇳Changchun, China
Women's Hospital, Zhejaing University School of Medicine
🇨🇳Hangzhou, China
Zhejiang Cancer Hospital, Huangzhou
🇨🇳Huangzhou, China
Hunan Cancer Hospital
🇨🇳Changsha, China
First affiliated hospital college of XianJiaotong University
🇨🇳Xian, China
Obstetris and Gynecology Hospital of Fudan University
🇨🇳Shanghai, China
The First Affiliated Hospital of Soochow Universit
🇨🇳Suzhou, China
75PARIS, H Tenon, Onco
🇫🇷Paris, France
CAC François Baclesse
🇫🇷Caen Cedex, France
Sapir Medical Centre
🇮🇱Kfar Saba, Israel
69LYON, C Bérard, Onco
🇫🇷Lyon Cedex 08, France
Rambam Health Care Campus
🇮🇱Haifa, Israel
Centre Catherine de Sienne
🇫🇷Nantes,, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre Les Nancy, France
Institut Gustave Roussy
🇫🇷Villejuif Cedex, France
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Leningrad Regional Oncology Dispensary
🇷🇺St.Petersburg, Russian Federation
Royal Marsden Hospital and Institute of Cancer Research
🇬🇧Sutton, United Kingdom
Cancer Research UK and UCL Cancer Trials Centre
🇬🇧London, United Kingdom
Smilow Cancer Hospital at Yale New Haven
🇺🇸New Haven, Connecticut, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Gynecologic Cancer Center
🇺🇸Orlando, Florida, United States
Norton Cancer Institute Research
🇺🇸Louisville, Kentucky, United States
UNC Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
The Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
University of Hawaii
🇺🇸Honolulu, Hawaii, United States
University of Wisconsin-Madison
🇺🇸Madison, Wisconsin, United States
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