Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Lee-May Chen
Photo of Lee-May Chen
Lee-May Chen

Description

Summary

This study is a double-blind, randomized, placebo-controlled (2:1 niraparib:placebo) study in patients with Stage III or IV ovarian cancer. Patients must have completed front-line platinum based regimen with a physician-assessed response of Complete Response (CR) or Partial Response (PR). Additionally, patients must have a normal or >90% decrease in cancer antigen 125 (CA-125) following front-line platinum treatment. The study will assess the efficacy of niraparib as maintenance treatment, as measured by PFS.

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Keywords

Ovarian Neoplasms Ovarian Cancer PARP Inhibitor HRD HRD positive PRIMA PRIMA Clinical Trial PRIMA Study Carcinoma, Ovarian Epithelial Niraparib

Eligibility

You can join if…

Open to females ages 18 years and up

  • Patient must have histologically confirmed, advanced (FIGO Stage III or IV) high-grade predominantly serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have completed first line platinum based chemotherapy (neoadjuvant or adjuvant)
  • Patient must have clinical complete response or partial response following completion of chemotherapy course.
  • All Stage IV patients are eligible, irrespective of residual disease, after primary or interval debulking. Stage III patients are required to have visible residual disease after primary surgery. Patients with inoperable Stage III and IV disease are eligible
  • Patient must agree to undergo central tumor HRD testing
  • Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed
  • Patient must be randomized within 12 weeks of the first day of the last cycle of chemotherapy

You CAN'T join if...

  • Patient has mucinous or clear cell subtypes of epithelial ovarian cancer, carcinosarcoma or undifferentiated ovarian cancer
  • Patient has undergone more than 2 debulking surgeries
  • Patient is to receive bevacizumab as maintenance treatment
  • Patient is pregnant, breastfeeding, or expecting to conceive children, while receiving study treatment and for 180 days after the last dose of study treatment
  • Patient has had prior treatment with a known PARP inhibitor
  • Patient has been diagnosed and/or treated for any invasive cancer (other than study disease) less than 5 years prior to study enrollment.

Locations

  • GSK Investigational Site
    San Francisco California 94115 United States
  • GSK Investigational Site
    San Francisco California 94118 United States

Lead Scientist at UCSF

  • Lee-May Chen
    Dr. Lee-may Chen is the Division Director and Program Director for the UCSF/KPSF Gynecologic Oncology Fellowship Program. She is deeply committed to education and improving the outcomes of gynecologic cancer care. Since 2008, I have been the director of the UCSF Gynecologic Cancer Risk Program.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Tesaro, Inc.
ID
NCT02655016
Phase
Phase 3
Study Type
Interventional
Last Updated