Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02544633 | Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET | PHASE2 | COMPLETED | 68 | — | — | Oct 1, 2015 | Jan 1, 2019 | Mar 4, 2020 | 94 | United States, Australia +7 |
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.
| 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) |
| 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...