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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00583674 | Phase 2 Study of AMG 386 (20060439) in Combination With Cisplatin & Capecitabine in Subjects With Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma | PHASE2 | COMPLETED | 171 | — | — | Dec 1, 2007 | Jun 1, 2012 | May 7, 2014 | - | — |
| Arm | Type | Description |
|---|---|---|
| B | EXPERIMENTAL | - |
| A | EXPERIMENTAL | - |
| C | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AMG 386 placebo | DRUG | AMG 386 placebo IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death |
| AMG 386 10mg/kg | DRUG | AMG 386 10 mg/kg IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death |
| AMG 386 3mg/kg | DRUG | AMG 386 3 mg/kg IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death |
| Cisplatin | DRUG | Cisplatin 80 mg/m2 IV Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death |
| Capecitabine | DRUG | Capecitabine1000 mg/m2 PO BID x 14 days Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death |
Inclusion Criteria: * Disease Related * Histologically or cytologically confirmed adenocarcinoma of the stomach, gastroesophageal junction or distal esophagus with metastatic disease * Measurable or non-measurable disease per RECIST Guidelines * Prior gastrectomy (total or partial) may be al...