A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Women with Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received at Least Three Previous Chemotherapy Regimens

SUMMARY

 

This is a study of the effects of niraparib on ovarian, fallopian tube, or primary peritoneal cancer. Patients with ovarian, peritoneal, or fallopian tube cancer who agree to be in this study will take niraparib capsules by mouth once daily.

This study is being done to help find out if niraparib, the study drug, can help delay worsening of ovarian, peritoneal, or fallopian cancer among patients who have received at least three previous courses of a chemotherapy drug. This type of treatment, given with the hope of preventing worsening of the cancer after having received at least three previous chemotherapy courses, is known as “fourth line” therapy, referring to the fourth line of treatment.

There will be approximately 225 patients participating in this study within the United States.

COH Protocol Number : 15156

ClinicalTrials.gov Number : NCT02354586

Principal Investigator : Cristea, Mihaela M.D.

Sponsor : TESARO

BRIEF ELIGIBILITY CRITERIA :

Eligible Ages : >=18

Gender : Female

Minimum Performance Status : ECOG/SWOG:1

Treatment Intent : Non-Adjuvant treatment

Prior Chemotherapy :

Brain Metastases :

Measurable Disease :