Study of Mocetinostat in Patients With Urothelial Carcinoma Having Inactivating Alterations of Specific Genes
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
1 other identifier
interventional
17
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2014
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2014
CompletedFirst Posted
Study publicly available on registry
September 10, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedSeptember 1, 2017
August 1, 2017
1.5 years
September 4, 2014
August 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients experiencing tumor size reduction
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).
Up to 4 months
Secondary Outcomes (2)
Number of patients experiencing adverse events
Up to 12 months
Peak blood plasma concentration of mocetinostat
Up to 48 hours
Study Arms (1)
Mocetinostat
EXPERIMENTALMocetinostat (MGCD0103) oral capsules three times weekly, 70 mg doses in first month, with increase to 90 mg doses if tolerated
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
University of Alabama
Birmingham, Alabama, 35294, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
Florida Cancer Specialists
Fort Myers, Florida, 33905, United States
University of Chicago
Chicago, Illinois, 60637, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Washington University
St Louis, Missouri, 63110, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of Rochester
Rochester, New York, 14627, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Related Publications (1)
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.
PMID: 30570744DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2014
First Posted
September 10, 2014
Study Start
October 1, 2014
Primary Completion
April 1, 2016
Study Completion
July 1, 2016
Last Updated
September 1, 2017
Record last verified: 2017-08