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Also known as Glesatinib
MGCD265 · 4 trials · 3 indications
Objective disease response is defined as the percent of patients documented by investigator assessment to have a confirmed Complete Response (CR) or Partial Response (PR) in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for target and non-target lesions as assessed by CT or MRI. CR is defined as complete disappearance of all target lesions with the exception of nodal disease; PR is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions; Stable Disease (SD) is concluded when the response does not qualify for CR, PR or Progression; Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions.
To compare the rate and extent of absorption of two MGCD265 oral formulations at dose level of 100 mg administered as 1 x 100 mg oral dose (Formulation A) and 2 x 50 mg oral dose (Formulation B) under fasting conditions.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | MGCD265 in patients with MET activating mutations in tumor tissue |
| Arm 2 | EXPERIMENTAL | MGCD265 in patients with MET gene amplifications in tumor tissue |
| Arm 3 | EXPERIMENTAL | MGCD265 in patients with MET activating mutations in blood (circulating tumor DNA) |
| Arm 4 | EXPERIMENTAL | MGCD265 in patients with MET gene amplifications in blood (circulating tumor DNA) |
| MGCD265 | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MGCD265 | DRUG | MGCD265 is a small molecule multi-targeted receptor tyrosine kinase inhibitor |
Inclusion Criteria: * Diagnosis of non-small cell lung cancer * Metastatic or locally advanced disease * Prior platinum chemotherapy or immunotherapy * Test result showing genetic change in MET tumor gene * At least one tumor that can be measured on a radiographic scan Exclusion Criteria: * Prior...
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MGCD265 is an investigational small molecule being studied in oncology for advanced cancer, advanced malignancies, and non-small cell lung cancer. It has been evaluated in biomarker-selected non-small cell lung cancer patients whose tumors carry activating genetic alterations in MET. It is not an approved therapy and remains in clinical development.
MGCD265 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company has sponsored the clinical trial program for the compound, including studies in advanced malignancies and in non-small cell lung cancer with MET activating genetic alterations.
MGCD265 has been studied in Phase 1 and Phase 2 clinical trials. The Phase 2 study evaluated the drug in non-small cell lung cancer patients with activating genetic alterations in MET, while the Phase 1 studies enrolled patients with advanced malignancies and healthy subjects. No trials are currently active, and all listed studies are completed.
MGCD265 has been evaluated in completed trials including NCT02544633, a Phase 2 study in non-small cell lung cancer with MET activating genetic alterations, and NCT01930006, a Phase 1 study of two oral formulations in healthy subjects. Additional completed Phase 1 studies include NCT00697632 and NCT00679133 in advanced malignancies.
MGCD265 is not approved and remains an investigational agent in clinical development. It has completed Phase 1 and Phase 2 trials in advanced cancer, advanced malignancies, and non-small cell lung cancer, but no regulatory approval has been granted for any indication based on the available development information.