Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

March 6, 2019

Primary Completion Date

October 31, 2023

Study Completion Date

December 31, 2025

Conditions
Metastatic Endometrial Cancer
Interventions
DRUG

Rucaparib

Participants allocated to the active ingredient arm will receive Rucaparib twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Medication should be taken around the same time every day, with 8 or more ounces of water.

DRUG

Placebo Oral Tablet

Participants allocated to the placebo arm will receive a placebo tablet (that looks identical to the active ingredient tablet) twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Tablet should be taken around the same time every day, with 8 or more ounces of water.

Trial Locations (1)

80045

University of Colorado Hospital, Aurora

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Clovis Oncology, Inc.

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

lead

University of Colorado, Denver

OTHER