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Mocetinostat in advanced urothelial carcinoma
NCT02236195Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2014
- Primary completion
- Apr 2016
- Countries
- 1
- Sponsor
- Mirati Therapeutics
- Modality
- Covalent Small Molecules, Classical Binding Small Molecules
- Drugs
- mocetinostat
- Conditions
- urothelial carcinoma (UC)
01
Overview
Phase 2, open-label, single-arm trial of mocetinostat in urothelial carcinoma (UC), sponsored by Mirati Therapeutics. Primary endpoint: Number of patients experiencing tumor size reduction up to 4 months. Started Oct 2014; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Mocetinostat
Mocetinostat monotherapy
03
Who it enrols
Patients with metastatic or locally advanced urothelial carcinoma, prior platinum chemotherapy, and CREBBP/EP300 alterations. Excludes uncontrolled brain tumors and impaired heart function.
04
Endpoints
Primary
Number of patients experiencing tumor size reduction
Secondary
Number of patients experiencing adverse events
Peak blood plasma concentration of mocetinostat
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