Ovarian Cancer Clinical Trial
Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
Summary
A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (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)) who have responded following platinum based chemotherapy.
Full 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.
Eligibility Criteria
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 2 Locations for this study
Birmingham Alabama, , United States
San Francisco California, , United States
Aurora Colorado, , United States
New Britain Connecticut, , United States
Orlando Florida, , United States
Evanston Illinois, , United States
Baltimore Maryland, , United States
Baltimore Maryland, , United States
Boston Massachusetts, , United States
Boston Massachusetts, , United States
Voorhees New Jersey, , United States
Albany New York, , United States
Mineola New York, , United States
Hilliard Ohio, , United States
Nashville Tennessee, , United States
Milwaukee Wisconsin, , United States
Heidelberg , , Australia
Parkville , , Australia
Randwick , , Australia
Gent , , Belgium
Leuven , , Belgium
Barretos , , Brazil
Fortaleza , , Brazil
Goiânia , , Brazil
Ijuí , , Brazil
Itajai , , Brazil
Porto Alegre , , Brazil
Porto Alegre , , Brazil
São José do Rio Preto , , Brazil
São Paulo , , Brazil
São Paulo , , Brazil
Hamilton Ontario, , Canada
London Ontario, , Canada
Toronto Ontario, , Canada
Toronto Ontario, , Canada
Montreal Quebec, , Canada
Sherbrooke Quebec, , Canada
Quebec , , Canada
Beijing , , China
Beijing , , China
Changchun , , China
Changchun , , China
Changsha , , China
Chengdu , , China
Chongqing , , China
Guangzhou , 51006, China
Hangzhou , , China
Harbin , , China
Huangzhou , , China
Ji Nan , , China
Shanghai , 20001, China
Shanghai , , China
Suzhou , , China
Xian , , China
Bordeaux , , France
Caen Cedex , , France
Lyon Cedex 08 , , France
Nantes, , , France
Paris Cedex 5 , , France
Paris , , France
Paris , , France
Pierre Benite Cedex , , France
Saint Cloud , , France
Toulouse , , France
Vandoeuvre Les Nancy , , France
Villejuif Cedex , , France
Berlin , , Germany
Erlangen , , Germany
Essen , , Germany
Frankfurt , , Germany
Hannover , , Germany
Lübeck , , Germany
München , , Germany
Ravensburg , , Germany
Rostock , , Germany
Haifa , , Israel
Kfar Saba , , Israel
Ramat Gan , , Israel
Milano , , Italy
Modena , , Italy
Napoli , , Italy
Padova , , Italy
Roma , , Italy
Roma , , Italy
Akashi-shi , , Japan
Chuo-ku , , Japan
Fukuoka , , Japan
Hidaka-shi , , Japan
Matsuyama-shi , , Japan
Niigata-shi , , Japan
Osakasayama-shi , , Japan
Sapporo-shi , , Japan
Sunto-gun , , Japan
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Amsterdam , , Netherlands
Maastricht , , Netherlands
Nijmegen , , Netherlands
Rotterdam , , Netherlands
Grzepnica , , Poland
Olsztyn , , Poland
Olsztyn , , Poland
Warszawa , , Poland
Warszawa , , Poland
Moscow , , Russian Federation
Saint Petersburg , , Russian Federation
St.Petersburg , , Russian Federation
Barcelona , , Spain
Barcelona , , Spain
Córdoba , , Spain
Gerona , , Spain
Madrid , , Spain
Madrid , , Spain
Pamplona , , Spain
Valencia , , Spain
Valencia , , Spain
Birmingham , , United Kingdom
Cambridge , , United Kingdom
Coventry , , United Kingdom
Edinburgh , , United Kingdom
London , , United Kingdom
London , , United Kingdom
Manchester , , United Kingdom
Sutton , , United Kingdom
How clear is this clinincal trial information?