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

• ClinicalTrials.gov Identifier: NCT02236195
• Recruitment Status: Completed
• First Posted: September 10, 2014
• Last Update Posted: September 1, 2017
• Sponsor: Mirati Therapeutics Inc.
• Information provided by (Responsible Party): Mirati Therapeutics Inc.

Tracking Information

• First Submitted Date: September 4, 2014
• First Posted Date: September 10, 2014
• Last Update Posted Date: September 1, 2017
• Study Start Date: October 2014
• Actual Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 8, 2014)

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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 8, 2014)

• Number of patients experiencing adverse events [ Time Frame: Up to 12 months ]
• Peak blood plasma concentration of mocetinostat [ Time Frame: Up to 48 hours ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Mocetinostat in Patients With Urothelial Carcinoma Having Inactivating Alterations of Specific Genes
• 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
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Urothelial Carcinoma

Intervention

Drug: Mocetinostat

Other Name: MGCD0103

Study Arms

Experimental: Mocetinostat

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

Intervention: Drug: Mocetinostat

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 16, 2016): 17
• Original Estimated Enrollment (submitted: September 8, 2014): 15
• Actual Study Completion Date: July 2016
• Actual Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02236195
• Other Study ID Numbers: 0103-018
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Mirati Therapeutics Inc.
• Original Responsible Party: MethylGene Inc.
• Current Study Sponsor: Mirati Therapeutics Inc.
• Original Study Sponsor: MethylGene Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Mirati Therapeutics Inc.
• Verification Date: August 2017