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

Conditions

• Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• OLAPARIB — DRUG
  300 mg olaparib tablets taken orally twice daily. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria.
• Single agent chemotherapy — DRUG
  Treatment of relapsed disease with single agent chemotherapy based on physician's choice of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria

Study Details

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 Dates

Start date

Feb 6, 2015

Status verified

Jul 2022

Primary completion

Oct 10, 2018

Completion

Jul 19, 2022

Study Design

Enrollment

266 participants (actual)

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Arms

• Experimental: 1/OLAPARIB
  olaparib 300mg oral tablets; twice daily
• Active Comparator: 2/CHEMOTHERAPY
  Physician's choice single agent chemotherapy

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months) ]

Locations (22)

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