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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01234038 | Safety and Tolerability Study of ISIS EIF4E Rx in Combination With Carboplatin and Paclitaxel | PHASE1 | COMPLETED | 116 | — | — | Nov 1, 2010 | Jan 1, 2013 | Jun 27, 2018 | 29 | United States, Hungary +2 |
| Arm | Type | Description |
|---|---|---|
| Part 1 Cohort 1 | EXPERIMENTAL | - |
| Part 1 Cohort 2 | EXPERIMENTAL | - |
| Part 2 Arm A | EXPERIMENTAL | - |
| Part 2 Arm B | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ISIS EIF4E Rx | DRUG | 800 mg ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle |
| Paclitaxel | DRUG | 200 mg/m2 administered as a 3-hour intravenous infusion on Day 1 of each 21 day cycle |
| Carboplatin | DRUG | AUC 6.0 mg/mL/min administered as a 1-hour intravenous infusion on Day 1 of each 21 day cycle |
Inclusion Criteria: * Male or female patients age \>/= 18 years * Histologically or cytologically confirmed diagnosis of NSCLC * Stage IV disease (including patients with pleural effusion who were previously classified as Stage IIIB) * All of the following if patient has had prior radiation therapy...