Study of Mocetinostat in Patients With Urothelial Carcinoma Having Inactivating Alterations of Specific Genes
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
17 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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