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Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer

NCT03025867 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2017-04-17

No results posted yet for this study

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.

Conditions

  • Recurrent Ovarian Cancer

Interventions

DRUG

Niraparib

Sponsors & Collaborators

  • Tesaro, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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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 NCT03025867 on ClinicalTrials.gov