Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status

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

Study Details

This is a non-randomized, open-label study to assess olaparib tablets as a treatment for subjects with different homologous recombination deficiency (HRD) tumor status and with platinum-sensitive, relapsed, high-grade serous or high-grade endometrioid ovarian cancer. Subjects should have received at least 1 prior line of platinum-based chemotherapy.

Key Dates

Start date

Dec 22, 2016

Status verified

Mar 2022

Primary completion

Dec 3, 2020

Completion

Dec 3, 2020

Study Design

Enrollment

272 participants (actual)

Allocation

NA

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: gBRCAm;
  germline BRCA mutant
• Experimental: sBRCAm and germline BRCA wild type;
  somatic BRCA mutant, germline BRCA wild type
• Experimental: myChoice® HRD positive and BRCAwt;
  genomic instability positive and no BRCA mutation
• Experimental: myChoice® HRD negative and BRCAwt
  genomic instability negative and no BRCA mutation

Primary Outcome Measure

Objective Response Rate, Defined as the Percentage of Subjects With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) [ Time Frame: From first dose up until progression, or last evaluable assessment in the absence of progression (up to 36 months) ]

Locations (35)

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