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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02236195
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Drug: Mocetinostat Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mocetinostat
Mocetinostat (MGCD0103) oral capsules three times weekly, 70 mg doses in first month, with increase to 90 mg doses if tolerated
Drug: Mocetinostat
Other Name: MGCD0103




Primary Outcome Measures :
  1. Number of patients experiencing tumor size reduction [ Time Frame: 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 :
  1. Number of patients experiencing adverse events [ Time Frame: Up to 12 months ]
  2. Peak blood plasma concentration of mocetinostat [ Time Frame: Up to 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236195


Locations
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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33905
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
University of Rochester
Rochester, New York, United States, 14627
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Mirati Therapeutics Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02236195    
Other Study ID Numbers: 0103-018
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Keywords provided by Mirati Therapeutics Inc.:
Urothelial
Bladder
HDAC
MGCD0103
Mocetinostat
CREBBP
EP300
Mirati
MethylGene
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Mocetinostat
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action