Research and Clinical Trials

Title  
AMGEN 102 20060317: 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 Epi
Brief Description  
This is a randomized, Phase 1b/2 study for previously untreated subjects with unresectable locally advanced or metastatic gastric or esophagogastric junction adenocarcinoma. The purpose of this study is to help determine safe dose levels of the study drug (AMG 102) to combine with ECX (epirubicin, cisplatin, and capecitabine), which is a standard therapy for gastric or esophagogastric cancer. The study will also measure the treatment effect of the study drug when given in combination with ECX as
Who may be Eligible  
Inclusion Criteria:
  • 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 Criteria:
  • 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
IRB Number  
07-08-07B
Principal Investigator  
Salmon, Stuart

For More Information, Contact  Delois  , DeShazo
Phone:  (704) 355-1342  Fax:  (704) 355-1353  
Email:  delois.deShazo@carolinashealthcare.org
Address:1100 South Tryon Street Suite 220 Charlotte, NC 28203
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