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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02435121 | A Study Assessing Efficacy and Safety of SAR125844 in NSCLC Patients With MET Amplification | PHASE2 | COMPLETED | 1 | — | — | Nov 1, 2015 | Jan 1, 2016 | Mar 23, 2016 | 1 | Belgium |
| NCT01657214 | Phase I, Dose Escalation of SAR125844 in Asian Solid Tumor Patients | PHASE1 | COMPLETED | 70 | — | — | Sep 1, 2012 | Jan 1, 2016 | Feb 17, 2016 | 8 | Japan, South Korea |
| Arm | Type | Description |
|---|---|---|
| SAR125844 | EXPERIMENTAL | Given intravenously weekly at the dose of 570 mg/m\^2 for at least 18 weeks |
| Dose escalation | EXPERIMENTAL | SAR125844 will be administered as weekly IV infusion. Four weekly administrations are considered as 1 cycle. The starting dose will be either 1 dose level (DL) below the highest cleared dose level in a European TED11449 ongoing study or DL4 (260 mg/m\^2), if the highest cleared dose in TED11449 is \>340 mg/m\^2. |
| Name | Type | Description |
|---|---|---|
| SAR125844 | DRUG | Pharmaceutical form:Concentrate for solution Route of administration: intravenous |
Inclusion criteria: Metastatic non-small-cell lung cancer patients with progressive disease during or after first or second line therapy harboring MET gene amplification and with measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Exclusion criteria: Patient less than...