Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. (SOLO-1)
Newly Diagnosed, Advanced Ovarian Cancer, FIGO Stage III-IV
About this trial
This is an interventional treatment trial for Newly Diagnosed focused on measuring BRCA, Ovarian Cancer, Chemotherapy, PARP inhibitor, First Line, FIGO Stage III, FIGO Stage IV
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Clearview Cancer Institute
- Providence Cancer Center
- St. Joseph's Hospital & Medical Center
- Cedars-Sinai Medical Center
- University of California, Los Angeles
- Kaiser Permanente
- Kaiser Permanente
- Stanford Women's Cancer Center
- Babak Edraki
- University of Colorado
- Univ of Connecticut Health Center
- Smilow Cancer Hospital at Yale New Haven
- Florida Hospital Cancer Institute
- Gynecologic Cancer Center
- H Lee Moffitt Cancer Center and Research Institute
- Northside Hospital
- Northeast Georgia Medical Center
- Nancy N. & J.C. Lewis Cancer and Research Pavillion
- The Queen's Medical Center
- University of Hawaii
- Northwestern University
- Univ Chicago Medical Center
- Advocate Lutheran General Hospital
- Indiana University
- St. Vincent Hospital & Health Care Center
- Northern Indiana Cancer Research Consortium
- McFarland Clinic, P.C.
- Norton Cancer Institute Research
- Maine Medical Partners
- Greater Baltimore Medical Center
- Johns Hopkins
- Walter Reed National Military Medical Center
- Beth Israel Deaconess Medical Center
- Dana Farber Cancer Institute
- Massachusetts General Hospital
- Henry Ford Health System
- Gynecologic Oncology of West MI, PLLC
- Minnesota Oncology Hematology, PA
- Mayo Clinic - Rochester, MN
- University of Mississippi Medical Center
- Washington University School of Medicine
- Missouri Valley Cancer Consortium CCOP
- Nebraska Methodist Hospital
- Womens Cancer Center of Nevada
- MD Anderson at Cooper Cancer Center
- John Theurer Cancer Center
- University of New Mexico
- Women's Cancer Care Associates
- Roswell Park Cancer Institute
- Memorial Sloan Kettering Cancer Center
- Mount Sinai Medical Center - New York
- Perlmutter Cancer Center
- Hope Women's Cancer Centers
- UNC Chapel Hill
- Levine Cancer Institute
- Duke University Medical Center
- Sanford Roger Maris Cancer Center
- Aultman Hospital
- Cleveland Clinic Cancer Center at Fairview Hospital
- Cleveland Clinic Foundation
- University Hospital Case Medical Center
- Research Site
- Kettering Medical Center
- Hillcrest Hospital Cancer Center
- Peggy and Charles Stephenson Cancer Center
- Abington Memorial Hospital
- St. Luke's University Health Network
- The University of Pennsylvania
- Women and Infants Hospital
- South Carolina Oncology Associates, PA
- Avera Cancer Institute
- Sanford Clinic Women's Health
- University of Texas Southwestern Medical Center
- MD Anderson Cancer Center
- University of Texas Health Science Center of Houston
- University of Virginia
- Virginia Oncology Associates
- Carilion Clinic Gynecological Oncology
- Aurora Baycare Medical Center
- University of Wisconsin-Madison
- Froedtert Memorial Hospital
- Mercy Hospital for Women
- The Royal Womens Hospital
- Prince of Wales Hospital
- Centro Diagnóstico Barretos
- Hospital Araujo Jorge
- Centro de Novos Tratamentos Itajai
- Hospital de Clinicas de Porto Alegre
- Irmandade da Santa Casa de Misericordia de Porto Alagre
- Hospital de Base São José do Rio Preto
- Centro de Referencia da Saude da Mulher
- Instituto do Câncer de São Paulo
- Juravinski Cancer Centre
- London Health Sciences Centre
- Princess Margaret Cancer Centre
- Sunnybrook Health Sciences Center
- CHUM - Hopital Norte-Dame
- Royal Victoria Hospital
- Hotel-Dieu de Quebec
- Beijing Cancer Hospital
- The Tumor Hospital affiliated to China Medical Science Insti
- 1st Hospital of Jilin university
- Jilin Provincial Cancer Hospital
- Hunan Cancer Hospital
- West China Hospital Affiliated to Sichuan University
- ChongQing Cancer Hospital
- Research Site
- Women's Hospital, Zhejaing University School of Medicine
- The Tumour Hospital of Harbin Medical University
- Zhejiang Cancer Hospital, Huangzhou
- JINAN, Qi Lu Hosp. of SD Univ.
- Obstetris and Gynecology Hospital of Fudan University
- Shanghai Cancer Hospital of Fudan University
- The First Affiliated Hospital of Soochow Universit
- First affiliated hospital college of XianJiaotong University
- Institut Bergonie
- CAC François Baclesse
- 69LYON, C Bérard, Onco
- Centre Catherine de Sienne
- 75PARIS, H Tenon, Onco
- Centre Alexis Vautrin
- Institut Gustave Roussy
- Rambam Health Care Campus
- Sapir Medical Centre
- Rabin MC
- Chaim Sheba Medical Centre
- Tel-Aviv Sourkasy Medical Center
- Bari- Istituto Tumori Giovanni Paolo II
- Azienda Ospedaliera "Cannizzaro"
- Istituto Europeo di Oncologia
- Istituto Nazionale Per Cura Tumori - Milano
- Istituto Nazionale Tumori Fondazione Pascale
- Istituto Oncologico Veneto Irccs
- Istituto Regina Elena-Polo Oncologico Ifo
- Policlinico Universitario A. Gemelli
- Hyogo CC
- National Cancer Center Hosp
- NHO Kyushu CC
- Saitama Med. Univ. Int. Med. C
- NHO Shikoku Cancer Center
- Niigata Univ. Med. Dent.
- Hokkaido University Hospital
- Shizuoka Cancer Center
- National Cancer Center
- Asan Medical Center
- Gangnam Severance Hospital
- Korea Cancer Center Hospital
- Samsung Medical Center
- Seoul National University Hospital
- Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital
- Maastricht Universitair Medisch Centrum
- Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna
- SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii
- Wojewódzki Szpital Specjalistyczny w Olsztynie
- Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
- Szpital Specjalistyczny im. Swietej Rodziny SPZOZ
- Udmurtia Republic Clinical Oncology Center
- Chemotherapy Department, Russian Cancer Research Centre
- State Institution of Heath Omsk Regional Oncology Dispensary
- Cancer Research Institute
- St.Petersburg City Oncology Dispensary, Dept. Gynecology
- Leningrad Regional Oncology Dispensary
- Research Institute of Oncology RAMS
- Barcelona,H.Vall d´Hebrón,Oncología
- Córdoba,H.Reina Sofía,Oncología
- H.Llobregat,ICO-Duran i Reynals,Oncología
- Madrid, MD Anderson, Oncología
- Madrid,H.U.La Paz,Oncología
- Valencia, IVO, Oncología
- Valencia,H.C.U.Valencia,Oncología
- City Hospital, Birmingham, Cancer Trials Team
- Addenbrooke's Hospital
- Arden Cancer Centre
- Edinburgh Cancer Research UK Centre
- Cancer Research UK and UCL Cancer Trials Centre
- Royal Marsden Hospital
- Royal Marsden Hospital and Institute of Cancer Research
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Olaparib tablets p.o. 300mg twice daily
Placebo tablets p.o. twice daily
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/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