Overview

This trial is active, not recruiting.

Condition urothelial carcinoma
Treatment mocetinostat
Phase phase 2
Target HDAC
Sponsor Mirati Therapeutics Inc.
Start date October 2014
End date December 2016
Trial size 17 participants
Trial identifier NCT02236195, 0103-018

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Mocetinostat (MGCD0103) oral capsules three times weekly, 70 mg doses in first month, with increase to 90 mg doses if tolerated
mocetinostat MGCD0103

Primary Outcomes

Measure
Number of patients experiencing tumor size reduction
time frame: Up to 4 months

Secondary Outcomes

Measure
Number of patients experiencing adverse events
time frame: Up to 12 months
Peak blood plasma concentration of mocetinostat
time frame: Up to 48 hours

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Mirati Therapeutics Inc..
Location data was received from the National Cancer Institute and was last updated in July 2016.