Olaparib 300mg tablets: Olaparib/placebo tablets p.o 300mg twice daily for up to 2 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.
Study summary
Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
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.
Trial sites (177)
Facility
City
Region
Status
Clearview Cancer Institute
Huntsville
Alabama
Providence Cancer Center
Anchorage
Alaska
St. Joseph's Hospital & Medical Center
Phoenix
Arizona
Cedars-Sinai Medical Center
Los Angeles
California
University of California, Los Angeles
Los Angeles
California
Kaiser Permanente
Oakland
California
Kaiser Permanente
Roseville
California
Stanford Women's Cancer Center
Stanford
California
Babak Edraki
Walnut Creek
California
University of Colorado
Aurora
Colorado
Univ of Connecticut Health Center
Farmington
Connecticut
Smilow Cancer Hospital at Yale New Haven
New Haven
Connecticut
Florida Hospital Cancer Institute
Orlando
Florida
Gynecologic Cancer Center
Orlando
Florida
H Lee Moffitt Cancer Center and Research Institute
Tampa
Florida
Northside Hospital
Atlanta
Georgia
Northeast Georgia Medical Center
Gainesville
Georgia
Nancy N. & J.C. Lewis Cancer and Research Pavillion
Savannah
Georgia
The Queen's Medical Center
Honolulu
Hawaii
University of Hawaii
Honolulu
Hawaii
Northwestern University
Chicago
Illinois
Univ Chicago Medical Center
Chicago
Illinois
Advocate Lutheran General Hospital
Park Ridge
Illinois
Indiana University
Indianapolis
Indiana
St. Vincent Hospital & Health Care Center
Indianapolis
Indiana
Northern Indiana Cancer Research Consortium
Mishawaka
Indiana
McFarland Clinic, P.C.
Ames
Iowa
Norton Cancer Institute Research
Louisville
Kentucky
Maine Medical Partners
Scarborough
Maine
Greater Baltimore Medical Center
Baltimore
Maryland
Johns Hopkins
Baltimore
Maryland
Walter Reed National Military Medical Center
Bethesda
Maryland
Beth Israel Deaconess Medical Center
Boston
Massachusetts
Dana Farber Cancer Institute
Boston
Massachusetts
Massachusetts General Hospital
Boston
Massachusetts
Henry Ford Health System
Detroit
Michigan
Gynecologic Oncology of West MI, PLLC
Grand Rapids
Michigan
Minnesota Oncology Hematology, PA
Edina
Minnesota
Mayo Clinic - Rochester, MN
Rochester
Minnesota
University of Mississippi Medical Center
Jackson
Mississippi
+ 137 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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