MedTrace Logo

Olaparib Expanded Access Program for BRCA Mutated Platinum Sensitive Relapsed High Grade Epithelial Ovarian Cancer Patients in Japan

NCT03063710 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2018-05-17

No results posted yet for this study

Summary

This is a single-arm, open label, expanded access program to provide access to olaparib tablets for relapsed high-grade epithelial ovarian cancer patients (including patients with primary peritoneal and / or fallopian tube 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.

Patients may continue to receive study treatment until disease progression as assessed by the investigator according to local standard clinical practice or any other discontinuation criteria are met.

Conditions

  • PSR Ovarian Cancer With a BRCA Mutation

Interventions

DRUG

olaparib

Initial dose is 300mg twice daily. Study treatment can be dose reduced to 250 mg bd as a first step and to 200 mg bd as a second step. There is no maximum duration for taking study treatment. Patients may continue to receive study treatment until disease progression as assessed by the investigator according to local standard clinical practice or any other discontinuation criteria.

Sponsors & Collaborators

Eligibility

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

Timeline & Regulatory

Countries

  • Japan

More Related Trials

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 NCT03063710 on ClinicalTrials.gov