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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00769483 | MK-0646 and Gemcitabine +/- Erlotinib for Patients With Advanced Pancreatic Cancer | PHASE1 | COMPLETED | 81 | — | — | Nov 13, 2008 | Sep 1, 2020 | Sep 3, 2020 | 1 | United States |
MK-0646 10 mg/kg was declared to be the MTD in combination with gemcitabine and 5 mg/kg the MTD in combination with Gemcitabine and erlotinib
Time interval (in months) from date of randomization until the date of first documented progression or date of death from any cause, whichever came first
| Arm | Type | Description |
|---|---|---|
| Phase I, Arm A | EXPERIMENTAL | MK-0646 + Gemcitabine |
| Phase I, Arm B | EXPERIMENTAL | MK-0646 + Gemcitabine + Erlotinib |
| Phase II, Arm A | EXPERIMENTAL | Gemcitabine + Erlotinib |
| Phase II, Arm B | EXPERIMENTAL | MK-0646 + Gemcitabine + Erlotinib |
| Phase II, Arm C | EXPERIMENTAL | Gemcitabine + Erlotinib |
| Name | Type | Description |
|---|---|---|
| MK-0646 | DRUG | Starting Dose Level: 5 mg/kg given intravenously over 60 minutes Days 1, 8, 15, 22 of 28 Day Cycle. |
| Gemcitabine | DRUG | 1000 mg/m\^2 given intravenously over 1-1/2 hours Days 1, 8, and 15 of each 28 Day Cycle. |
| Erlotinib | DRUG | 100 mg by mouth daily. |
Inclusion Criteria: 1. Pathologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma, AJCC stage IV 2. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as =/\>20 mm wi...