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Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT03617679
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : March 11, 2019
Sponsor:
Collaborators:
Clovis Oncology, Inc.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Metastatic Endometrial Cancer Drug: Rucaparib Drug: Placebo Oral Tablet Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Active ingredient vs placebo
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 : September 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Rucaparib

Arm Intervention/treatment
Active Comparator: Active Ingredient
1:1 Randomization. Participants in this arm receive the active ingredient medication.
Drug: Rucaparib
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Provision to sign and date the consent form.
  2. Stated willingness to comply with all study procedures and be available for the duration of the study.
  3. Be a female aged 18-89.
  4. Patients with a primary Stage III/IV or recurrent endometrial cancer.
  5. Patients have received at least one prior chemotherapy regimen and no more than two prior cytotoxic regimens (including hormonal therapy).
  6. Primary chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles.
  7. Previous cytotoxic regimen at least 4 weeks before initiation and no more than 8 weeks from initiation after last dose of previous therapy.
  8. 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.
  9. ECOG performance status of 0, 1 or 2.
  10. ANC > or = 1500 cells/microliters
  11. Platelet count > 100,000 microliters
  12. Hemoglobin > or = 9.0 g/dL
  13. Serum albumin > or = 2.5 g/dL
  14. Total bilirubin ≤ 1.5 x ULN
  15. AST and ALT ≤ 3.0 x ULN
  16. Serum Creatinine ≤ 1.5x ULN

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Inability to comply with study and follow-up procedures
  2. 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
  3. 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
  4. Participation in investigational clinical trial within last 30 days
  5. History of significant chronic disease including HIV/AIDS or hepatitis C
  6. Inability to provide informed consent
  7. Known CNS malignancy or CNS metastases
  8. 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.
  9. History of stroke or transient ischemic attack (TIA) within 3 months prior to cycle 1 day 1(C1D1)
  10. Major surgical procedure within 28 days prior to C1D1 or anticipation of needing a major surgical procedure during the course of the study
  11. Women with prognosis for survival less than 6 months
  12. Patients who have progressed or have stable disease (SD) through most recent chemotherapy regimen
  13. Patients deemed otherwise clinically unfit for clinical trial per Investigator's discretion
  14. Patients with duodenal stent or other GI disorder/defect that would interfere with absorption of oral medication
  15. Female patients who maintain fertility potential and refuse to comply to use contraception and be followed for pregnancy by pregnancy testing
  16. Non-study related minor surgical procedure < or = 5 days or major surgeries < or = 21 days prior to first dose of treatment

Information from the National Library of Medicine

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


Contacts
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Contact: Dina Flink 303-724-8467 dina.flink@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Dina Flink    303-724-8467    dina.flink@ucdenver.edu   
Principal Investigator: Bradley Corr, MD         
Sponsors and Collaborators
University of Colorado, Denver
Clovis Oncology, Inc.
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Bradley Corr, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03617679     History of Changes
Other Study ID Numbers: 18-0567.cc
P30CA046934 ( U.S. NIH Grant/Contract )
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
Rucaparib
Placebo
Randomized
Double Blind
Stage III/IV

Additional relevant MeSH terms:
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Rucaparib
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents