AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Capecitabine; Cisplatin; Epirubicin; Rilotumumab

Criteria

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