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Rucaparib Maintenance Therapy for Endometrial Cancer

Phase 2
Waitlist Available
Led By Bradley Corr, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be a female aged 18-89
Patients with a primary Stage III/IV or recurrent endometrial cancer
Must not have
Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the past 3 months, unstable arrhythmias, or unstable angina
Known clinically significant liver disease defined as AST and ALT > 3.0 x ULN and/or Total bilirubin > or = 1.5 x ULN, or documented history of active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months.

Summary

This trial will test if Rucaparib can help shrink endometrial cancer that has come back or spread after 1-2 other treatments.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Rucaparib may cause side effects like nausea, fatigue, increased risk of infections due to low blood cell counts, changes in liver enzymes indicating potential liver issues, and other common drug-related adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged between 18 and 89.
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My condition is advanced (Stage III/IV) or recurrent endometrial cancer.
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I completed radiation therapy on my pelvis or spine over 4 weeks ago.
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I can take care of myself and am up and about more than half of my waking hours.
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I completed 4 to 8 cycles of my first chemotherapy regimen.
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I have had 1 or 2 previous cancer treatments, including chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have serious heart conditions like recent heart attacks or unstable heart disease.
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I have significant liver disease or high liver enzyme levels.
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I have a condition that affects how my body absorbs pills.
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My doctor expects I have less than 6 months to live.
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I have cancer that has spread to my brain.
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My cancer did not improve after my last chemotherapy.
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I have not had a stroke or mini-stroke in the last 3 months.
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I have a history of a significant chronic disease like HIV/AIDS or hepatitis C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival (PFS)
Secondary study objectives
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Overall Survival (OS)

Trial Design

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).

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,922 Total Patients Enrolled
74 Trials studying Endometrial Cancer
73,294 Patients Enrolled for Endometrial Cancer
University of Colorado, DenverLead Sponsor
1,805 Previous Clinical Trials
2,822,267 Total Patients Enrolled
Clovis Oncology, Inc.Industry Sponsor
64 Previous Clinical Trials
10,937 Total Patients Enrolled
3 Trials studying Endometrial Cancer
91 Patients Enrolled for Endometrial Cancer

Media Library

Active Ingredient Clinical Trial Eligibility Overview. Trial Name: NCT03617679 — Phase 2
Endometrial Cancer Research Study Groups: Active Ingredient, Placebo
Endometrial Cancer Clinical Trial 2023: Active Ingredient Highlights & Side Effects. Trial Name: NCT03617679 — Phase 2
Active Ingredient 2023 Treatment Timeline for Medical Study. Trial Name: NCT03617679 — Phase 2
~12 spots leftby Nov 2025
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