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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01231347 | QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas | PHASE3 | COMPLETED | 800 | — | — | Apr 7, 2011 | Dec 12, 2012 | Jul 16, 2024 | 152 | United States, Australia +30 |
| NCT00630552 | QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer | PHASE1 | COMPLETED | 138 | — | — | Jun 1, 2007 | Apr 1, 2012 | Oct 17, 2024 | 44 | United States |
The primary endpoint of the study was OS, defined as the time from randomization to death.
The incidence of adverse events and clinical laboratory abnormalities defined as DLTs. A DLT was defined as any grade 3 or higher hematologic or non-hematologic toxicity related to any study treatment.
The proportion of subjects alive at 6 months
| Arm | Type | Description |
|---|---|---|
| Placebo + gemcitabine | PLACEBO_COMPARATOR | Arm 1: AMG 479-placebo IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle |
| AMG 479 12 mg/kg dose + gemcitabine | EXPERIMENTAL | Arm 2: AMG 479 12 mg/kg IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle |
| AMG 479 20 mg/kg + gemcitabine | EXPERIMENTAL | Arm 3: AMG 479 20 mg/kg IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle |
| Phase 1b AMG 655 3mg/kg | EXPERIMENTAL | Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine. |
| Phase 1b AMG 655 10mg/kg | EXPERIMENTAL | Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine. |
| Phase 2 AMG 655 | EXPERIMENTAL | Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion. |
| Phase 2 AMG 479 | EXPERIMENTAL | Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion. |
| Phase 2 AMG 655-placebo | PLACEBO_COMPARATOR | Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion. |
| Name | Type | Description |
|---|---|---|
| AMG 479 | DRUG | AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle |
| Placebo | DRUG | Placebo administered intravenously on days 1 and 15 of a 28 day cycle |
| gemcitabine | DRUG | gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle |
| AMG 655 | DRUG | AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2). |
Inclusion Criteria: * Untreated metastatic adenocarcinoma of the pancreas * Adequate hematologic, renal and liver function * Eastern Cooperative Oncology Group (ECOG) 0 or 1 Exclusion Criteria: * Prior chemotherapy or radiotherapy for pancreatic cancer * Central nervous system metastases * Extern...