Trials / Completed
CompletedNCT00719550
AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer
A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects With Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line Treatment With Epirubicin, Cisplatin, and Capecitabine(ECX) Plus AMG 102
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 130 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Study Phase: 1b/2 Indication: Previously untreated subjects with unresectable locally advanced or metastatic gastric or esophagogastric junction adenocarcinoma. Primary Objective(s): Part 1: To identify safe dose levels of AMG 102, up to 15 mg/kg Q3W, to combine with ECX. Part 2 (phase 2-double-blind): To estimate with pre-specified precision the effect of the addition of AMG 102 to ECX on progression free survival (PFS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Capecitabine | Administered at 625mg/m2 BID orally every day while on study. |
| DRUG | Epirubicin | Administered day 1 of each cycle at 50mg/m2 IV. |
| DRUG | AMG 102 | Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment. |
| DRUG | Cisplatin | Administered day 1 of each cycle at 60mg/m2 IV. |
| DRUG | Placebo | AMG 102 placebo will be provided in similar vials as clear, colorless, sterile protein-free solution |
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2010-11-01
- Completion
- 2013-06-01
- First posted
- 2008-07-21
- Last updated
- 2013-12-05
Source: ClinicalTrials.gov record NCT00719550. Inclusion in this directory is not an endorsement.