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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00851045 | Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer | PHASE2 | COMPLETED | 17 | — | — | Oct 1, 2009 | Oct 1, 2011 | Oct 12, 2015 | 15 | United States, Argentina +1 |
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322 |
| Arm 2 | ACTIVE_COMPARATOR | Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution) |
| Name | Type | Description |
|---|---|---|
| Irinotecan | DRUG | Solution, IV, 180 mg/m2, Q14 days, Until PD |
| 5-Fluorouracil (bolus) | DRUG | Solution, IV, 400 mg/m2, Q14 days, Until PD |
| 5-Fluorouracil (infusional) | DRUG | Solution, IV, 2400 mg/m2, Q14 days, Until PD |
| Leucovorin calcium | DRUG | Solution, IV, 400 mg/m2, Q14 days, Until PD |
| CT-322 | DRUG | Solution, IV, 2 mg/kg, Q7 days, Until PD |
| Bevacizumab | DRUG | Solutions, IV, 5 mg/kg, Q14 days, Until PD |
| Bevacizumab Placebo (saline solution) | DRUG | Solution, IV, 0 mg/kg, On day 8 of a 2-week cycle, Until PD |
Inclusion Criteria: * ECOG Performance Status (PS) ≤1 * Histologically or cytologically confirmed, unresectable metastatic colorectal cancer * Measurable disease by RECIST guidelines * Evidence of disease progression following first-line therapy with a fluoropyrimidine, oxaliplatin, and bevacizumab...