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Study of Mocetinostat in Patients With Urothelial Carcinoma Having Inactivating Alterations of Specific Genes

NCT02236195

Description:

Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. This study is a Phase 2 trial evaluating the efficacy of mocetinostat in patients that have advanced urothelial carcinoma that has specific changes in tumor genes. Patients must have previously received treatment with chemotherapy that included a "platinum-containing agent" such as cisplatin. The study will enroll in stages, with 15 patients in the first stage. More patients will be added to the study if enough patients having beneficial responses are observed. Mocetinostat will be administered using oral capsules three times each week (eg, Monday, Wednesday and Friday). The study is designed to evaluate whether the number of patients responding to treatment is substantially higher than would be expected with other available treatments.

Related Conditions:
  • Urothelial Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Study of Mocetinostat in Patients With Urothelial Carcinoma Having Inactivating Alterations of Specific Genes

Title

  • Brief Title: Study of Mocetinostat in Patients With Urothelial Carcinoma Having Inactivating Alterations of Specific Genes
  • Official Title: An Open-Label, Single-Arm, Phase 2 Study of Mocetinostat in Selected Patients With Inactivating Alterations of Acetyltransferase Genes in Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma
  • Clinical Trial IDs

    NCT ID: NCT02236195

    ORG ID: 0103-018

    Trial Conditions

    Urothelial Carcinoma

    Trial Interventions

    Drug Synonyms Arms
    Mocetinostat MGCD0103 Mocetinostat

    Trial Purpose

    Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. This study is a
    Phase 2 trial evaluating the efficacy of mocetinostat in patients that have advanced
    urothelial carcinoma that has specific changes in tumor genes. Patients must have previously
    received treatment with chemotherapy that included a "platinum-containing agent" such as
    cisplatin. The study will enroll in stages, with 15 patients in the first stage. More
    patients will be added to the study if enough patients having beneficial responses are
    observed. Mocetinostat will be administered using oral capsules three times each week (eg,
    Monday, Wednesday and Friday). The study is designed to evaluate whether the number of
    patients responding to treatment is substantially higher than would be expected with other
    available treatments.

    Detailed Description

    To be eligible for this study, patient tumor testing must demonstrate a genetic alteration
    resulting in the loss of function of the Histone Acetyltransferase (HAT) family genes,
    CREBBP and/or EP300, including gene deletions or selected inactivating mutations. If testing
    has not already been performed, the study will provide for the testing.

    Trial Arms

    Name Type Description Interventions
    Mocetinostat Experimental Mocetinostat (MGCD0103) oral capsules three times weekly, 70 mg doses in first month, with increase to 90 mg doses if tolerated Mocetinostat

    Eligibility Criteria

    Inclusion Criteria:

    - Diagnosis of urothelial carcinoma

    - Metastatic or locally advanced disease

    - Prior chemotherapy that included a platinum agent

    - Test results showing genetic change in tumor gene for CREBBP and/or EP300

    - At least one tumor that can be measured

    Exclusion Criteria:

    - Uncontrolled tumor in the brain

    - Impaired heart function

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Number of patients experiencing tumor size reduction

    Secondary Outcome Measures

    Number of patients experiencing adverse events

    Peak blood plasma concentration of mocetinostat

    Trial Keywords

    Urothelial

    Bladder

    HDAC

    MGCD0103

    Mocetinostat

    CREBBP

    EP300

    Mirati

    MethylGene