EUCTR2008-001605-42-GR
Active, not recruiting
Not Applicable
A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects with UnresectableLocally Advanced or Metastatic Gastric or Esophagogastric Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line Treatment with Epirubicin, Cisplatin, and Capecitabine(ECX) plus AMG 102
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- nrespectable locally advanced or metastatic gastric or esophagogastric junction adenocarcinoma
- Sponsor
- Amgen Inc
- Enrollment
- 138
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria
- •4\.1\.1 Disease related
- •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
- •Life expectancy \= 3 months
- •4\.1\.2 Demographic
- •Male or female \= 18 years of age
- •4\.1\.3 Ethical
Exclusion Criteria
- •Exclusion Criteria
- •4\.2\.1 Disease Related
- •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. Patients previously treated with
- •anthracyclines must not exceed total cumulative dose of epirubicin of 900 mg/m2
- •(or equivalent thereof, if a different anthracycline has been administered in the
- •past) including doses to be administered in this trial.
- •Any prior or synchronous malignancy (except for non\-melanomatous skin cancer
Outcomes
Primary Outcomes
Not specified
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