Rucaparib Maintenance Therapy for Endometrial Cancer

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.

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

I am a woman aged between 18 and 89.

My condition is advanced (Stage III/IV) or recurrent endometrial cancer.

I completed radiation therapy on my pelvis or spine over 4 weeks ago.

I can take care of myself and am up and about more than half of my waking hours.

I completed 4 to 8 cycles of my first chemotherapy regimen.

I have had 1 or 2 previous cancer treatments, including chemotherapy.

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.

I have a condition that affects how my body absorbs pills.

My doctor expects I have less than 6 months to live.

I have cancer that has spread to my brain.

My cancer did not improve after my last chemotherapy.

I have not had a stroke or mini-stroke in the last 3 months.

I have a history of a significant chronic disease like HIV/AIDS or hepatitis C.

Treatment Details

The 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.

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).