Overview

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