Rucaparib Maintenance Therapy for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

Overseen byBradley Corr, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Colorado, Denver

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Bradley Corr, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for women aged 18-89 with Stage III/IV or recurrent endometrial cancer who've had 1-2 prior chemo treatments. They must have completed their last chemo cycle at least 4 weeks ago, be in fairly good health (ECOG status of 0, 1, or 2), and have adequate blood counts and liver function. Women must not be pregnant and agree to use contraception.

Inclusion Criteria

Platelet count > 100,000 microliters

I am a woman aged between 18 and 89.

Hemoglobin > or = 9.0 g/dL

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Exclusion Criteria

I do not have serious heart conditions like recent heart attacks or unstable heart disease.

I have significant liver disease or high liver enzyme levels.

Participation in investigational clinical trial within last 30 days

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Treatment Details

Interventions

Placebo (Chemotherapy)
Rucaparib (PARP Inhibitor)

Trial OverviewThe study tests Rucaparib as a maintenance therapy against a placebo in women with metastatic or recurrent endometrial cancer after they've received one to two lines of chemotherapy. The goal is to see if Rucaparib can help keep the cancer from growing back.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Active IngredientActive Control1 Intervention

1:1 Randomization. Participants in this arm receive the active ingredient medication.

Group II: PlaceboPlacebo Group1 Intervention

1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients).