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NCT Number: NCT02236195

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

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.

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Key information

Conditions

Urothelial Carcinoma Abnormalities, Multiple Bone Diseases Bone Diseases, Developmental Carcinoma Carcinoma, Transitional Cell Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Dysostoses Genetic Diseases, Inborn Intellectual Disability Musculoskeletal Abnormalities Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Rubinstein-Taybi Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alabama, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mocetinostat

Drug

Other names: MGCD0103

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mirati Therapeutics Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 10, 2014
Registry last updated
Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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