Skip to main content

A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens

Trial Status: Closed to Accrual

This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.

Inclusion Criteria

  • Patients must agree to undergo tumor HRD testing and blood gBRCAmut status testing.
  • Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed
  • Patients must have histologically diagnosed high-grade (Grade 2 or 3) serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with recurrent disease and must have been previously treated with chemotherapy and experienced a response lasting at least 6 months to first-line platinum based therapy.
  • Patients Must have completed 3 or 4 previous chemotherapy regimens.
  • Patients must have completed their last chemotherapy regimen > 4 weeks prior to treatment initiation.
  • Patients must have measurable disease according to RECIST (v.1.1).
  • Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer or agree to undergo fresh biopsy prior to study treatment initiation.
  • Patients must agree to blood samples during screening and at the end of treatment for cytogenetic analysis.

Exclusion Criteria

  • Patients must not have any known, persistent (> 4 weeks), ≥Grade 3 hematologic toxicity during the last cancer therapy. Patients must not have any known, persistent (>4 weeks), ≥ Grade 3 fatigue during the last cancer therapy.
  • Patients must not have received pelvic radiotherapy as treatment for primary or recurrent disease within 1 year of the first dose of study treatment.
  • Patients must not have symptomatic uncontrolled brain or leptomeningeal metastases.
  • Patients must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active, uncontrolled infection.
  • Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment.
  • Patients must not have known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

California

Duarte
City of Hope Comprehensive Cancer Center
Status: COMPLETED
Palo Alto
Stanford Cancer Institute Palo Alto
Status: COMPLETED

Connecticut

New Haven
Yale University
Status: CLOSED_TO_ACCRUAL

Florida

Tampa
Moffitt Cancer Center
Status: COMPLETED
Contact: Hye Sook Chon
Phone: 813-745-7205

Illinois

Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: CLOSED_TO_ACCRUAL

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: CLOSED_TO_ACCRUAL
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: COMPLETED
Detroit
Wayne State University / Karmanos Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: CLOSED_TO_ACCRUAL
Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: COMPLETED
Contact: SCC Clinical Trials Office
Phone: 405-271-8777

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
San Antonio
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Status: COMPLETED

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Tesaro Inc

  • Primary ID 213360
  • Secondary IDs NCI-2015-01245, PR-30-5020-C
  • Clinicaltrials.gov ID NCT02354586