Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mocetinostat · 3 trials · 3 indications
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).
Percentage of subjects with dose-limiting toxicities (DLTs) as assessed by NCI CTCAE (Version 4.03)
The MTD is the highest dose associated with first-cycle DLT in \< 33% of subjects
| Arm | Type | Description |
|---|---|---|
| Mocetinostat | EXPERIMENTAL | Mocetinostat (MGCD0103) oral capsules three times weekly, 70 mg doses in first month, with increase to 90 mg doses if tolerated |
| Treatment (vinorelbine, mocetinostat) | EXPERIMENTAL | Participants receive mocetinostat in combination with vinorelbine |
| Mocetinostat and azacitidine | EXPERIMENTAL | Drug: Mocetinostat (MGCD0103) Mocetinostat (a histone deacetylase \[HDAC\] inhibitor) 70 mg or 90 mg dose, oral capsules 3 times weekly beginning on day 5 for 10 doses in each 28 day cycle Drug: Azacitidine (Vidaza) Azacitidine (a hypomethylating agent \[HMA\]) 75 mg/m2 dose, by intravenous (IV) infusion or subcutaneous (SC) injection beginning on day 1 for 7 doses in each 28 day cycle |
| Name | Type | Description |
|---|---|---|
| Mocetinostat | DRUG | - |
| Vinorelbine | DRUG | Given IV |
| Azacitidine | DRUG | Azacitidine (a hypomethylating agent \[HMA\]) 75 mg/m2 dose, by intravenous (IV) infusion or subcutaneous (SC) injection beginning on day 1 for 7 doses in each 28 day cycle |
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: * Uncontro...
Mocetinostat is an investigational small molecule being studied for the treatment of Myelodysplastic Syndrome, Rhabdomyosarcoma, and Urothelial Carcinoma. It is in clinical development for these oncology indications, though it is not yet approved by the FDA.
Mocetinostat is a histone deacetylase (HDAC) inhibitor that targets HDAC1, HDAC2, HDAC3, HDAC8, and HDAC11. By inhibiting these enzymes, it is being studied for its potential effects in treating certain cancers.
Mocetinostat is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY on the stock exchange. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer types.
Mocetinostat is in Phase 1 and Phase 2 clinical trials. It is an investigational drug still in clinical development and has not received FDA approval. The trials are studying its use in Myelodysplastic Syndrome, Rhabdomyosarcoma, and Urothelial Carcinoma.
Mocetinostat has been studied in several clinical trials, including NCT02018926 for Myelodysplastic Syndrome, NCT02236195 for Urothelial Carcinoma, and NCT04299113 for Rhabdomyosarcoma. These trials have been completed or are active but not recruiting.
Mocetinostat is a specific HDAC inhibitor that targets HDAC1, HDAC2, HDAC3, HDAC8, and HDAC11. It is distinct from other HDAC inhibitors due to its unique target profile, though it shares the same class of mechanism.