Clinical Trials /

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

URL:

https://clinicaltrials.gov/show/NCT02236195

Trial Eligibility

Document

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

  • ORG STUDY ID: 0103-018
  • NCT ID: NCT02236195

Conditions

  • Urothelial Carcinoma

Interventions

DrugSynonymsArms
MocetinostatMGCD0103Mocetinostat

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

NameTypeDescriptionInterventions
MocetinostatExperimentalMocetinostat (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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of patients experiencing tumor size reduction
Time Frame:Up to 4 months
Safety Issue:
Description:Tumors will be measured using radiographic scans. Tumor size reduction and overall disease response will be categorized according to the Response Evaluation Criteria In Solid Tumors (RECIST 1.1).

Secondary Outcome Measures

Measure:Number of patients experiencing adverse events
Time Frame:Up to 12 months
Safety Issue:
Description:
Measure:Peak blood plasma concentration of mocetinostat
Time Frame:Up to 48 hours
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Mirati Therapeutics Inc.

Trial Keywords

  • Urothelial
  • Bladder
  • HDAC
  • MGCD0103
  • Mocetinostat
  • CREBBP
  • EP300
  • Mirati
  • MethylGene

Last Updated

September 1, 2017