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

NCT00719550 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2013-12-05

No results posted yet for this study

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

  • Esophagogastric Junction Adenocarcinoma
  • Gastric Cancer
  • Esophageal Cancer

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-11-30
Completion
2013-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00719550 on ClinicalTrials.gov