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

Phase 2

Completed

• Conditions: Urothelial Carcinoma
• Interventions: Drug: Mocetinostat

• Registration Number: NCT02236195
• Lead Sponsor: Mirati Therapeutics Inc.

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 Timeline

• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-08
• Study First Posted: 2014-09-10
• Study Start: 2014-10
• Primary Completion: 2016-04
• Study Completion: 2016-07
• Status Verified: 2017-08
• Disposition First Submitted: 2017-08-29
• Disposition First Submitted QC: 2017-08-30
• Last Update Submitted: 2017-08-30
• Disposition First Posted: 2017-09-01
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mocetinostat	Mocetinostat	Mocetinostat (MGCD0103) oral capsules three times weekly, 70 mg doses in first month, with increase to 90 mg doses if tolerated

Primary Outcome Measures

Name	Time	Method
Number of patients experiencing tumor size reduction	Up to 4 months	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

Name	Time	Method
Number of patients experiencing adverse events	Up to 12 months
Peak blood plasma concentration of mocetinostat	Up to 48 hours

Trial Locations

Locations (14)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

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

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States