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 Epirubicin, Cisplatin, and Capecitabine(ECX) plus AMG 102 - 20060317

Conditions: Previously untreated subjects with unresectable locally advanced or metastatic gastric or esophagogastric junction adenocarcinoma.
MedDRA version: 9.1Level: LLTClassification code 10051635Term: Gastrointestinal tract adenoma

Registration Number: EUCTR2008-001605-42-IT

Lead Sponsor: Amgen Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 138

Inclusion Criteria

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 Demographic Male or female ≥ 18 years of age Ethical Before any study-specific procedure, the appropriate written informed consent must be obtained (see Section 12.1) Laboratory Hemoglobin ≥ 9 g/dL Absolute neutrophil count ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L (without transfusion within 14 days before enrollment or randomization) Creatinine clearance ≥ 60 mL/min (calculated or measured) Aspartate aminotransferase (AST) and alanine amino transferase (ALT) ≤ 2.5 x Upper Limit of Normal (ULN) (OR AST and ALT ≤ 5.0 x ULN in the presence of liver metastasis) Total bilirubin ≤ 1.5x ULN PTT ≤ 1.5 x ULN and INR ≤ ULN
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 dose(s) to be administered in this trial. Subjects with resectable disease or suitable for definitive chemoradiation Plans for surgical resection based on response to protocol therapy Subjects with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy Tumors of squamous cell histology Treatment with radiotherapy ≤ 14 days before enrollment or randomization Known central nervous system metastases Clinically significant upper gastro-intestinal bleeding ≤ 30 days prior to enrollment or randomization Cardiac Left ventricular ejection fraction (LVEF) < 50% as determined by either Multiple Gated Acquisition (MUGA) scan or echocardiogram (ECHO) Clinically significant (i.e. active) cardiac disease or myocardial infarction within the last 12 months before enrollment or randomization. Subjects with any history of clinically significant cardiac failure are excluded from study entry. Other Abnormal Medical Conditions Major surgery ≤ 30 days before enrollment or randomization Minor surgery (e,g. catheter or gastrostomy tube placement) ≤14 days before enrollment or randomization Known peripheral neuropathy > grade 1 Known dihydropyrimidine dehydrogenase deficiency (DPD) deficiency Any prior or synchronous malignancy (except for non-melanomatous skin cancer or in situ cervical cancer) other than the study disease, unless treated with curative intent and having completed all therapy, with no evidence of disease ≤ 5 years before enrollment or randomization Any clinically significant medical condition other than cancer, including cardiovascular disease or chronic obstructive pulmonary disease (COPD), which in the opinion of the investigator would interfere with the safe delivery of study treatment or increase risk of toxicity Known HIV infection, hepatitis C, chronic or active hepatitis B Serious or non-healing wound

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To estimate with pre-specified precision the effect of the addition of AMG 102 to ECX on progression free survival (PFS).;Secondary Objective: To evaluate the effect of the addition of AMG 102 to ECX on overall survival (OS), response rates, time to response, duration of response, disease control rates, and adverse events. To evaluate the pharmacokinetics (PK) of AMG 102, and estimate the impact of co-administration of AMG 102 on the PK of epirubicin and cisplatin (Part 2, phase 2 PK sub-study).;Primary end point(s): PFS

Secondary Outcome Measures

Name	Time	Method

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