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
Brief Summary
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of patients experiencing tumor size reduction
Secondary Outcome
Number of patients experiencing adverse events
Condition
Urothelial Carcinoma
Intervention
Mocetinostat
Study Arms / Comparison Groups
Mocetinostat
Description: Mocetinostat (MGCD0103) oral capsules three times weekly, 70 mg doses in first month, with increase to 90 mg doses if tolerated
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
17
Start Date
October 2014
Completion Date
July 2016
Primary Completion Date
April 2016
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02236195
Organization ID
0103-018
Responsible Party
Sponsor
Study Sponsor
Mirati Therapeutics Inc.
Study Sponsor
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Verification Date
August 2017