Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer
Primary Purpose
Metastatic Endometrial Cancer
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rucaparib
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Endometrial Cancer focused on measuring Rucaparib, Placebo, Randomized, Double Blind, Stage III/IV
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Sites / Locations
- University of Colorado Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active Ingredient
Placebo
Arm Description
1:1 Randomization. Participants in this arm receive the active ingredient medication.
1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients).
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS)
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.
Secondary Outcome Measures
Overall Survival (OS)
Overall survival is defined as cycle 1 day 1 (C1D1) till the time of death.
Overall Response Rate (ORR)
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]
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.
Full Information
NCT ID
NCT03617679
First Posted
July 17, 2018
Last Updated
July 21, 2023
Sponsor
University of Colorado, Denver
Collaborators
Clovis Oncology, Inc., National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03617679
Brief Title
Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer
Official Title
A Phase II, Randomized, Double-Blind Study of the Use of Rucaparib vs. Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 6, 2019 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Clovis Oncology, Inc., National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
This is a phase II clinical trial, that administers a maintenance treatment after first line chemotherapy is complete. It is designed to have a 1:1 randomization technique. Half the participants who enter the study will receive the active ingredient, Rucaparib, while the other half will receive a placebo. Treatment will be until progression with follow up until death.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Endometrial Cancer
Keywords
Rucaparib, Placebo, Randomized, Double Blind, Stage III/IV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Active ingredient vs placebo
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
138 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Ingredient
Arm Type
Active Comparator
Arm Description
1:1 Randomization. Participants in this arm receive the active ingredient medication.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients).
Intervention Type
Drug
Intervention Name(s)
Rucaparib
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
Start of study to end of study, or death, whichever comes first, up to 48 months.
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival is defined as cycle 1 day 1 (C1D1) till the time of death.
Time Frame
Start of study to death, up to 48 months.
Title
Overall Response Rate (ORR)
Description
ORR is defined as how well the tumor responds to the medication based on RECIST 1.1 evaluation.
Time Frame
Start of study to end of study, or death, whichever comes first, up to 48 months.
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
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.
Time Frame
Start of study to end of study, or death, whichever comes first, up to 48 months.
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley Corr, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer
We'll reach out to this number within 24 hrs