Clinical trial · Interventional
Study of Mocetinostat in Patients With Urothelial Carcinoma Having Inactivating Alterations of Specific Genes
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mocetinostat | Drug | Mocetinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mocetinostat
- description
- Mocetinostat (MGCD0103) oral capsules three times weekly, 70 mg doses in first month, with increase to 90 mg doses if tolerated
- interventionNames
- Drug: Mocetinostat
Primary outcomes (1)
- measure
- Number of patients experiencing tumor size reduction
- timeFrame
- Up to 4 months
- description
- 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 (2)
- measure
- Number of patients experiencing adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGrivas P, Mortazavi A, Picus J, Hahn NM, Milowsky MI, Hart LL, Alva A, Bellmunt J, Pal SK, Bambury RM, O'Donnell PH, Gupta S, Guancial EA, Sonpavde GP, Faltaos D, Potvin D, Christensen JG, Chao RC, Rosenberg JE. Mocetinostat for patients with previously treated, locally advanced/metastatic urothelial carcinoma and inactivating alterations of acetyltransferase genes. Cancer. 2019 Feb 15;125(4):533-540. doi: 10.1002/cncr.31817. Epub 2018 Dec 20. PMID 30570744