Ignite Creation Date:
2024-05-06 @ 3:13 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02236195
Status:
COMPLETED
Last Update Posted:
2017-09-01
First Post:
2014-09-04
Brief Title:
Study of Mocetinostat in Patients With Urothelial Carcinoma Having Inactivating Alterations of Specific Genes
Sponsor:
Mirati Therapeutics Inc
Organization:
Mirati Therapeutics Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor EP300 including gene deletions or selected inactivating mutations If testing has not already been performed the study will provide for the testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None