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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 belowSelect...
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:Select...
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.
Select...
I have not had a stroke or mini-stroke in the last 3 months.
Select...
I have a history of a significant chronic disease like HIV/AIDS or hepatitis C.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months.
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
13,938 Previous Clinical Trials
41,023,109 Total Patients Enrolled
74 Trials studying Endometrial Cancer
73,294 Patients Enrolled for Endometrial Cancer
University of Colorado, DenverLead Sponsor
1,808 Previous Clinical Trials
2,822,161 Total Patients Enrolled
Clovis Oncology, Inc.Industry Sponsor
64 Previous Clinical Trials
10,952 Total Patients Enrolled
3 Trials studying Endometrial Cancer
91 Patients Enrolled for Endometrial Cancer
Bradley Corr, MDPrincipal InvestigatorUniversity of Colorado, Denver
2 Previous Clinical Trials
93 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 am a woman aged between 18 and 89.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.I am a woman able to have children but choose not to use birth control.I haven't had minor surgery in the last 2 weeks or major surgery in the last 4 weeks.My condition is advanced (Stage III/IV) or recurrent endometrial cancer.I completed radiation therapy on my pelvis or spine over 4 weeks ago.My cancer did not improve after my last chemotherapy.I have not had a stroke or mini-stroke in the last 3 months.It's been 4-8 weeks since my last cancer treatment.I can take care of myself and am up and about more than half of my waking hours.I have a history of a significant chronic disease like HIV/AIDS or hepatitis C.I completed 4 to 8 cycles of my first chemotherapy regimen.I have had 1 or 2 previous cancer treatments, including chemotherapy.I have not had cancer, other than endometrial or non-serious skin cancers, in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Active Ingredient
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.