Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT03617679
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Endometrial Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Rucaparib — DRUG
    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.
  • Placebo Oral Tablet — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 6, 2019
Status verified
Mar 2026
Primary completion
Oct 31, 2023
Completion
Feb 27, 2026

Study Design

Enrollment
79 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active Ingredient
    1:1 Randomization. Participants in this arm receive the active ingredient medication.
  • Placebo Comparator: Placebo
    1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients).

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 48 months. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045-

Find similar trials in Aurora, CO

By research site
University of Colorado Hospital· Aurora, CO

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