Study of Mocetinostat in Patients With Urothelial Carcinoma Having Inactivating Alterations of Specific Genes
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/24/2016 |
| Start Date: | October 2014 |
| End Date: | December 2017 |
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
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.
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.
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.
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.
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
We found this trial at
14
sites
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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1500 East Duarte Road
Duarte, California 91010
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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