Clinical Trials /

Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer

NCT03617679

Description:

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.

Related Conditions:
  • Endometrial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: 18-0567.cc
  • SECONDARY ID: P30CA046934
  • NCT ID: NCT03617679

Conditions

  • Metastatic Endometrial Cancer

Interventions

DrugSynonymsArms
RucaparibActive Ingredient
Placebo Oral TabletPlacebo

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Active IngredientActive Comparator1:1 Randomization. Participants in this arm receive the active ingredient medication.
  • Rucaparib
PlaceboPlacebo Comparator1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients).
  • Placebo Oral Tablet

Eligibility 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
      
Maximum Eligible Age:89 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:Start of study to end of study, or death, whichever comes first, up to 48 months.
Safety Issue:
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.

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:Start of study to death, up to 48 months.
Safety Issue:
Description:Overall survival is defined as cycle 1 day 1 (C1D1) till the time of death.
Measure:Overall Response Rate (ORR)
Time Frame:Start of study to end of study, or death, whichever comes first, up to 48 months.
Safety Issue:
Description:ORR is defined as how well the tumor responds to the medication based on RECIST 1.1 evaluation.
Measure: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 Issue:
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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Colorado, Denver

Trial Keywords

  • Rucaparib
  • Placebo
  • Randomized
  • Double Blind
  • Stage III/IV

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