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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

NCT02282020 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2022-07-26

Study results available
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Summary

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.

Conditions

  • Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity

Interventions

DRUG

OLAPARIB

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.

DRUG

Single agent chemotherapy

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

Sponsors & Collaborators

Principal Investigators

  • Richard T Penson, Associate Prof. of Medicine · Harvard Medical School (HMS and HSDM)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-06
Primary Completion
2018-10-10
Completion
2022-07-19

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Poland
  • South Korea
  • Spain

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02282020 on ClinicalTrials.gov