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



Status:Active, not recruiting
Conditions:Ovarian Cancer, Neurology
Therapuetic Areas:Neurology, Oncology
Healthy:No
Age Range:18 - 127
Updated:4/4/2019
Start Date:September 3, 2013
End Date:September 30, 2021

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Phase 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

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.

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.

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.
We found this trial at
17
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Albany, New York 12208
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Aurora, Colorado 80045
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Baltimore, Maryland 21218
(410) 516-8000
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Evanston, Illinois 60201
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3651 Ridge Mill Drive
Hilliard, Ohio 43026
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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Milwaukee, WI
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Mineola, NY
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Nashville, Tennessee 37232
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100 Grand St
New Britain, Connecticut 06050
(860) 224-5011
The Hospital of Central Connecticut The Hospital of Central Connecticut is dedicated to fostering, sustaining...
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Orlando, Florida
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2340 Clay Street
San Francisco, California 94115
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Voorhees, NJ
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