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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02096666 | A Phase 1/2 Study Evaluating AMG 337 in Asian Subjects | PHASE1 | COMPLETED | 11 | — | — | Apr 15, 2014 | Dec 7, 2018 | Dec 28, 2021 | 4 | Japan |
Adverse events and clinical laboratory abnormalities defined as DLTs.
Determine anti-tumor activity of AMG 337 in subjects with MET amplified gastric/gastroesophageal junction/esophageal adenocarcinoma (cohort 1)
| Arm | Type | Description |
|---|---|---|
| Single arm | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AMG 337 | DRUG | Phase 1- AMG 337 150 mg, 200mg and 300 mg orally daily. Additional 150 mg and 200 mg orally twice daily. Phase 2- AMG 337 (dose determined by Phase 1) |
Inclusion Criteria: * Able to self administer daily AMG 337 as a whole capsule * Male or female 20 years of age or over * Phase 1: Subjects must have a pathologically confirmed, advanced solid tumor for which the subjects have received prior therapy for advanced disease, for which no standard thera...