Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT03617679|
Recruitment Status : Active, not recruiting
First Posted : August 6, 2018
Last Update Posted : March 13, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Metastatic Endometrial Cancer||Drug: Rucaparib Drug: Placebo Oral Tablet||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||138 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Active ingredient vs placebo|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase II, Randomized, Double-Blind Study of the Use of Rucaparib vs. Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer|
|Actual Study Start Date :||March 6, 2019|
|Estimated Primary Completion Date :||May 31, 2023|
|Estimated Study Completion Date :||September 2023|
Active Comparator: Active Ingredient
1:1 Randomization. Participants in this arm receive the active ingredient medication.
Participants allocated to the active ingredient arm will receive Rucaparib twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Medication should be taken around the same time every day, with 8 or more ounces of water.
Placebo Comparator: Placebo
1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients).
Drug: Placebo Oral Tablet
Participants allocated to the placebo arm will receive a placebo tablet (that looks identical to the active ingredient tablet) twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Tablet should be taken around the same time every day, with 8 or more ounces of water.
- Progression Free Survival (PFS) [ Time Frame: Start of study to end of study, or death, whichever comes first, up to 48 months. ]Progression free survival is defined as cycle 1 day 1 (C1D1) till the time of progression as determined by RECIST 1.1 criteria or death.
- Overall Survival (OS) [ Time Frame: Start of study to death, up to 48 months. ]Overall survival is defined as cycle 1 day 1 (C1D1) till the time of death.
- Overall Response Rate (ORR) [ Time Frame: Start of study to end of study, or death, whichever comes first, up to 48 months. ]ORR is defined as how well the tumor responds to the medication based on RECIST 1.1 evaluation.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Start of study to end of study, or death, whichever comes first, up to 48 months. ]Safety and tolerability analysis of Rucaparib will be summarized by dose and severity as assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5 and relationship to study drug.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 89 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Accepts Healthy Volunteers:||No|
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Be a female aged 18-89.
- Patients with a primary Stage III/IV or recurrent endometrial cancer.
- Patients have received at least one prior chemotherapy regimen and no more than two prior cytotoxic regimens (including hormonal therapy).
- Primary chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles.
- Previous cytotoxic regimen at least 4 weeks before initiation and no more than 8 weeks from initiation after last dose of previous therapy.
- Patients who receive radiation to the whole pelvis or at least 50% of the spine must complete radiation therapy and have at least 4 weeks' time elapse prior to initiation of drug.
- ECOG performance status of 0, 1 or 2.
- ANC > or = 1500 cells/microliters
- Platelet count > 100,000 microliters
- Hemoglobin > or = 9.0 g/dL
- Serum albumin > or = 2.5 g/dL
- Total bilirubin ≤ 1.5 x ULN
- AST and ALT ≤ 3.0 x ULN
- Serum Creatinine ≤ 1.5x ULN
An individual who meets any of the following criteria will be excluded from participation in this study:
- Inability to comply with study and follow-up procedures
- 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
- Participation in investigational clinical trial within last 30 days
- History of significant chronic disease including HIV/AIDS or hepatitis C
- Inability to provide informed consent
- Known CNS malignancy or CNS metastases
- Patients with previous malignancy, other than endometrial, within the past 2 years from cycle 1, day 1, with the exception of those with negligible risk of metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the breast.
- History of stroke or transient ischemic attack (TIA) within 3 months prior to cycle 1 day 1(C1D1)
- Women with prognosis for survival less than 6 months
- Patients who have progressed or have stable disease (SD) through most recent chemotherapy regimen
- Patients deemed otherwise clinically unfit for clinical trial per Investigator's discretion
- Patients with duodenal stent or other GI disorder/defect that would interfere with absorption of oral medication
- Female patients who maintain fertility potential and refuse to comply to use contraception and be followed for pregnancy by pregnancy testing
- Minor surgical procedure < or = 14 days or major surgeries < or = 28 days prior to first dose of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617679
|United States, Colorado|
|University of Colorado Hospital|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Bradley Corr, MD||University of Colorado, Denver|
|Responsible Party:||University of Colorado, Denver|
|Other Study ID Numbers:||
P30CA046934 ( U.S. NIH Grant/Contract )
|First Posted:||August 6, 2018 Key Record Dates|
|Last Update Posted:||March 13, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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