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Also known as MGCD0103
Mocetinostat · 10 trials · 10 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 |
| 1 | EXPERIMENTAL | MGCD0103 administered orally three times per week. |
| 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 |
| Treatment (vinorelbine, mocetinostat) | EXPERIMENTAL | Participants receive mocetinostat in combination with vinorelbine |
| Name | Type | Description |
|---|---|---|
| Mocetinostat | DRUG | - |
| MGCD0103 | DRUG | MGCD0103 Administered orally three times per week. |
| 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 |
| Gemcitabine | DRUG | Gemcitabine 1000mg/m\<2\> intravenously days 1, 8, 15 of a 28 day cycle. |
| Vinorelbine | DRUG | Given IV |
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...
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Mocetinostat is an investigational small molecule being studied for the treatment of Myelodysplastic Syndrome, Urothelial Carcinoma, and Rhabdomyosarcoma. It is in clinical development for these oncology indications, though it is not yet approved by the FDA.
Mocetinostat targets HDAC11, HDAC3, HDAC1, HDAC2, and HDAC8. It is an inhibitor of these histone deacetylase enzymes, which are involved in gene expression regulation and are relevant in cancer biology.
Mocetinostat is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. 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, Urothelial Carcinoma, and Rhabdomyosarcoma.
Mocetinostat has been studied in three clinical trials. NCT02018926 is a Phase 1 study in Myelodysplastic Syndrome, NCT02236195 is a Phase 2 study in Urothelial Carcinoma, and NCT04299113 is a Phase 1 study in Rhabdomyosarcoma. All are based in the United States.