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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start of study to death, up to 48 months.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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It's been 4-8 weeks since my last cancer treatment.
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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.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Overall Response Rate (ORR)
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
13,603 Previous Clinical Trials
40,913,137 Total Patients Enrolled
75 Trials studying Endometrial Cancer
72,425 Patients Enrolled for Endometrial Cancer
University of Colorado, DenverLead Sponsor
1,722 Previous Clinical Trials
2,113,364 Total Patients Enrolled
Clovis Oncology, Inc.Industry Sponsor
63 Previous Clinical Trials
10,033 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has a similar undertaking been attempted before?

"Since 2015, Active Ingredient has been intensely studied. It was first tested in a trial backed by Clovis Oncology, Inc., which included 924 participants and ultimately led to the drug's Phase 2 approval. Currently, 34 distinct experiments are being conducted across 831 cities located inside of 34 different countries."

Answered by AI

Is this research endeavor currently recruiting participants?

"This clinical trial, which was initially posted on March 6th 2019 and recently revised on June 16th 2022 is currently recruiting participants according to information housed on clinicaltrials.gov."

Answered by AI

Who can partake in the evaluation of this medical experiment?

"This clinical trial is open to 138 participants, between ages 18 and 89, who have metastatic endometrial cancer. In addition, in order to be considered for the study they must also meet a series of conditions such as having undergone at least one prior chemotherapy regimen with no more than two cytotoxic regimens (including hormonal therapy), completion of radiation if applicable within 8 weeks before initiation of drug, ECOG performance status 0-2 , ANC > or = 1500 cells/microliters and being a female aged 18-89 willing to comply with all study procedures.."

Answered by AI

Is eligibility for this research study restricted to individuals under the age of 35?

"The requirements for participation in this clinical trial necessitate that the potential patient is between 18 and 89 years old. This study has a total of 19 child participants, while 310 elderly individuals are enrolled."

Answered by AI

How many individuals are included in the research cohort?

"Affirmative. Clinicaltrials.gov displays that this medical experiment, which was initiated on March 6th 2019, is currently enrolling patients. 138 subjects must be enlisted from one particular hospital site."

Answered by AI

Has the Active Ingredient gained regulatory clearance from the FDA?

"Our experts at Power assessed the safety of Active Ingredient to be a 2, due to its standing as a Phase 2 trial, which implies limited data on efficacy and some evidence on safety."

Answered by AI
~23 spots leftby Mar 2025