Approval Probability
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Adjusted LOA
ML Risk
Also known as Mocetinostat
MGCD0103 · 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. |
| 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 | - |
| MGCD0103 | DRUG | MGCD0103 Administered orally three times per week. |
| 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 |
| Gemcitabine | DRUG | Gemcitabine 1000mg/m\<2\> intravenously days 1, 8, 15 of a 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...
MGCD0103 is an investigational small molecule being studied for the treatment of tumors, chronic lymphocytic leukemia, myelodysplastic syndrome, leukemia, and lymphoma. It is in Phase 1 clinical development and has not been approved by the FDA.
MGCD0103 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials of this investigational oncology drug.
MGCD0103 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. All completed trials for MGCD0103 are Phase 1 studies.
MGCD0103 has completed four Phase 1 trials, including NCT00323934, NCT00324129, NCT00324194, and NCT00372437. These studies enrolled patients with advanced solid tumors, non-Hodgkin's lymphoma, leukemia, and myelodysplastic syndromes.