Trial ID or NCT#

NCT02354586

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Investigator(s)

Jonathan S. Berek, MD, MMSc
Jonathan S. Berek, MD, MMSc
Gynecologic oncologist
Laurie Kraus Lacob Professor
Hans-Christoph Becker, MD, FSABI, FSCCT
Radiologist
Clinical Professor, Radiology
Oliver Dorigo, M.D., Ph.D.
Oliver Dorigo, M.D., Ph.D.
Gynecologic oncologist, Medical oncologist, Gynecologic oncologist
Associate Professor of Obstetrics and Gynecology (Oncology)

Contact us to find out if this trial is right for you.

CONTACT

CCTO
(650) 498-7061