drugset / Trial / NCT03025867

Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer

NCT03025867

Expanded access Approved for marketing Tesaro, Inc.

Summary

This is an expanded access program (EAP) for eligible patients with Recurrent Ovarian Cancer. This program is designed to provide access to niraparib prior to approval by the US Food and Drug Administration (FDA). To be eligible, patients with Recurrent Ovarian Cancer following a partial (PR) or complete response (CR) to their most recent platinum-based chemotherapy and must have experienced a PR or CR after the penultimate (next to last) platinum-based chemotherapy for at least 6 months without disease progression after this chemotherapy.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Niraparib Small molecule

Indications