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

Completed · Phase 2

Conditions studied: Urothelial Carcinoma

In brief

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.

Key facts

Study ID

NCT02236195

Run by

Mirati Therapeutics Inc.

People needed

17

Starts

2014-10-01

Expected to finish

2016-07-01

Last updated by the study team

2017-09-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Uncontrolled tumor in the brain
• Impaired heart function

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• City of Hope National Medical Center — Duarte, California, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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