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Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer

NCT03617679 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2026-03-24

Study results available
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Summary

This study seeks to determine the effectiveness of Rucaparib as maintenance therapy for metastatic and recurrent endometrial cancer, after 1-2 prior lines of therapy.

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.

Sponsors & Collaborators

  • Clovis Oncology, Inc.

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Bradley Corr, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-06
Primary Completion
2023-10-31
Completion
2026-02-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03617679 on ClinicalTrials.gov