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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01433263 | Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas | PHASE2 | COMPLETED | 57 | — | — | Aug 1, 2011 | Apr 1, 2014 | Mar 2, 2016 | 10 | United States, Lithuania +3 |
Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was no more than or equal to 2% at Week 8 was considered responders.
| Arm | Type | Description |
|---|---|---|
| 30mg/kg BYM338 | EXPERIMENTAL | - |
| Placebo / late 30mg/kg BYM338 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BYM338 active drug | DRUG | - |
| Placebo | DRUG | - |
Key Inclusion criteria: 1. Patients must sign an informed consent before assessment 2. Patients with pathologically and/or clinically confirmed diagnosis of stage IV non-small (squamous or non-squamous) cell lung cancer (NSCLC) or stage III/IV adenocarcinoma of the pancreas. 3. Patients with stage ...