Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments

Completed · Phase 3

Conditions studied: Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity

In brief

Comparison of olaparib vs. physician's choice of single agent standard of care non-platinum based chemotherapy in patients with germline Breast Cancer susceptibility gene (gBRCA) mutated ovarian cancer who have progressed at least 6 months after the last platinum based chemotherapy. Patient should have received at least 2 prior lines of platinum based chemotherapy. The aim of the study is to assess the efficacy and safety of olaparib tablets.

Key facts

Study ID

NCT02282020

Run by

AstraZeneca

People needed

266

Starts

2015-02-06

Expected to finish

2022-07-19

Last updated by the study team

2022-07-26

Who can join

Age: 18 and older, up to 130. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be ≥ 18 years of age
• Patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer. Patients are eligible to undergo BRCA testing even if they have not yet had recurrence or progression of disease >6 months (>/=183 days) after completion of their last platinum therapy.
• Documented germline mutation in Breast Cancer susceptibility genes: BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)
• At least one lesion that can be accurately assessed at baseline by CT/MRI and is suitable for repeated assessment.
• Patients must have received at least 2 prior platinum based lines of chemotherapy - Patients must be partially platinum sensitive or platinum sensitive
• Patients must be suitable to start treatment with single agent chemotherapy based on physician's choice
• Patients must have normal organ and bone marrow function measured within 28 days of randomisation,
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Patients must have a life expectancy ≥ 16 weeks
• Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing.

You may not qualify if…

• BRCA 1 and/or BRCA2 mutations that are considered to be non detrimental
• Exposure to any investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation
• Any previous treatment with a Polyadenosine 5'diphosphoribose polymerisation (PARP) inhibitor, including olaparib.
• Patients who have platinum resistant or refractory disease
• Patients receiving any systemic chemotherapy within 3 weeks prior to first dose of study treatment
• Previous single agent exposure to the selected chemotherapy regimen for randomisation. - Prior malignancy in the last 5 years, unless curatively treated and recurrence free (few exceptions apply).

Where it is running

• Research Site — Mobile, Alabama, United States
• Research Site — Sacramento, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Littleton, Colorado, United States
• Research Site — Hartford, Connecticut, United States
• Research Site — Fort Gordon, Georgia, United States
• Research Site — Covington, Louisiana, United States
• Research Site — Towson, Maryland, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Albany, New York, United States
• Research Site — Mineola, New York, United States
• Research Site — Chapel Hill, North Carolina, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Springfield, Oregon, United States
• Research Site — Abington, Pennsylvania, United States
• Research Site — Knoxville, Tennessee, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Bedford, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — Milwaukee, Wisconsin, United States
• Research Site — Berazategui, Argentina
• Research Site — CABA, Argentina
• Research Site — Ciudad de Buenos Aires, Argentina
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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