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

Sponsor

Mirati Therapeutics Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02236195

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

1.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Oct 1, 2014

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

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 Names: MGCD0103

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 Names:

MGCD0103

Outcome Measures

Primary Outcome Measures

Number of patients experiencing tumor size reduction [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294
2	City of Hope National Medical Center	Duarte	California	United States	91010
3	Florida Cancer Specialists	Fort Myers	Florida	United States	33905
4	University of Chicago	Chicago	Illinois	United States	60637
5	Johns Hopkins University	Baltimore	Maryland	United States	21287
6	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
7	University of Michigan	Ann Arbor	Michigan	United States	48109
8	Washington University	Saint Louis	Missouri	United States	63110
9	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
10	University of Rochester	Rochester	New York	United States	14627
11	University of North Carolina	Chapel Hill	North Carolina	United States	27599
12	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
13	Ohio State University	Columbus	Ohio	United States	43210
14	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112