Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer

NCT03025867 | Unknown

• 1 other identifier: 3000-07-001
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Recurrent Ovarian Cancer

Interventions

Niraparib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tesaro, Inc.: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

niraparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 20, 2017
• Last Updated: April 17, 2017

Record last verified: 2017-04