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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 developed by Bristol-Myers Squibb Company (BMY) for the treatment of advanced cancer, advanced malignancies, and non-small cell lung cancer. It has been studied in clinical trials, but it is not approved and remains in clinical development.
MGCD265 has been studied in patients with non-small cell lung cancer who have activating genetic alterations in MET. A Phase 2 trial evaluated its safety and efficacy in this patient population, though the drug remains investigational and is not approved for this or any other indication.
MGCD265 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company has sponsored clinical trials of this investigational small molecule in oncology indications, including advanced malignancies and non-small cell lung cancer.
MGCD265 has completed Phase 1 and Phase 2 clinical trials. The most advanced study was a Phase 2 trial in non-small cell lung cancer with MET alterations. However, the drug is still investigational and has not received FDA approval.
MGCD265 has been studied in several completed trials, including NCT00679133 and NCT00697632, which were Phase 1 safety studies in advanced malignancies. NCT01930006 was a Phase 1 trial in healthy subjects, and NCT02544633 was a Phase 2 study in non-small cell lung cancer with MET alterations.
MGCD265 is also known as glesatinib. This investigational small molecule has been evaluated under both names in clinical trials for advanced cancer and non-small cell lung cancer, and it is being developed by Bristol-Myers Squibb Company.