Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer

Sponsor
Tesaro, Inc.
Study ID
NCT03025867
Status
Approved For Marketing

Conditions

  • Recurrent Ovarian Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Status verified
Apr 2017

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