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

NCT ID: NCT02236195

Last Updated: 2017-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-07-31

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.

Conditions

Urothelial Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mocetinostat

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

Group Type: EXPERIMENTAL

Mocetinostat

Intervention Type: DRUG

Interventions

Mocetinostat

Intervention Type: DRUG

Other Intervention Names

MGCD0103

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mirati Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

References

Grivas P, Mortazavi A, Picus J, Hahn NM, Milowsky MI, Hart LL, Alva A, Bellmunt J, Pal SK, Bambury RM, O'Donnell PH, Gupta S, Guancial EA, Sonpavde GP, Faltaos D, Potvin D, Christensen JG, Chao RC, Rosenberg JE. Mocetinostat for patients with previously treated, locally advanced/metastatic urothelial carcinoma and inactivating alterations of acetyltransferase genes. Cancer. 2019 Feb 15;125(4):533-540. doi: 10.1002/cncr.31817. Epub 2018 Dec 20.

Reference Type: DERIVED

PMID: 30570744 (View on PubMed)

Other Identifiers

0103-018

Identifier Type: -

Identifier Source: org_study_id