Status:
COMPLETED
AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer
Lead Sponsor:
Amgen
Conditions:
Esophagogastric Junction Adenocarcinoma
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 iden...
Eligibility Criteria
Inclusion
- Pathologically confirmed unresectable locally advanced or metastatic gastric or esophagogastric junction (EGJ) adenocarcinoma; tumors of the distal esophagus within 5 cm of the EGJ are eligible
- ECOG performance status 0 or 1
- Male or female ≥ 18 years of age
Exclusion
- Previous systemic therapy (chemotherapy or biologic therapy) for locally advanced or metastatic gastric or esophagogastric adenocarcinoma
- Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy.
- Subjects with resectable disease or suitable for definitive chemoradiation
- Subjects with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy
- Tumors of squamous cell histology
- Known central nervous system metastases
- Clinically significant upper gastro-intestinal bleeding ≤ 30 days prior to enrollment or randomization
- Serious or non-healing wound
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00719550
Start Date
February 1 2009
End Date
June 1 2013
Last Update
December 5 2013
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