Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer

Sponsor

Tesaro, Inc. (Industry)

Overall Status

Approved for marketing

CT.gov ID

NCT03025867

Collaborator

(none)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Ovarian Cancer	Drug: Niraparib

Detailed Description

If a patient qualifies for participation in an ongoing niraparib clinical trial or is already participating in a niraparib clinical trial, she will not be able to participate in the EAP.

Ongoing clinical trials for niraparib include:

A Phase 3 trial in patients who have received first-line treatment for ovarian cancer (the PRIMA trial, NCT # 02655016)
A Phase 2 trial in patients who have received multiple lines of treatment for ovarian cancer (the QUADRA trial, NCT # 02354586)
A Phase 1/2 trial in patients with advanced or metastatic triple-negative breast cancer or recurrent ovarian cancer. (the TOPACIO trial, NCT # 02657889)

Study Design

Study Type:

Expanded Access

Official Title:

Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Inclusion Criteria:

Histologically diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
Completion of at least 2 previous courses of platinum-containing chemotherapy.
Had a CR or PR with duration of response >/=6 months following penultimate chemotherapy
Achieved a partial (PR) or complete (CR) tumor response following completion of the last platinum-containing chemotherapy [minimum of 4 cycles]
Patients previously treated with PARP inhibitors are eligible
Eastern Cooperative Oncology Group (ECOG, http://ecog-acrin.org/) performance status 0 or 1
Adequate organ function [Absolute neutrophil count (ANC) ≥ (greater than or equal to) 1,500/µL; Platelets ≥ (greater than or equal to) 100,000/µL; Hemoglobin ≥ (greater than or equal to) 9 g/dL]
Able to take oral medications
Women should not be pregnant at the beginning of the treatment and women or childbearing potential should not become pregnant while on niraparib
Patient should start treatment with niraparib no later than 12 weeks after completion of final dose of the platinum-containing chemotherapy

Exclusion Criteria:

Persistent ≥Grade 2 hematologic toxicity from prior cancer therapy
Known hypersensitivity to the components of niraparib
Patient is pregnant or breast feeding, or expecting to conceive children within the projected duration of the program treatment
Patient has uncontrolled hypertension

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tesaro, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tesaro, Inc.

ClinicalTrials.gov Identifier:

NCT03025867

Other Study ID Numbers:

3000-07-001

First Posted:

Jan 20, 2017

Last Update Posted:

Apr 17, 2017

Last Verified:

Apr 1, 2017

Additional relevant MeSH terms:

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Recurrence

Niraparib

Study Results

No Results Posted as of Apr 17, 2017