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

Conditions: nrespectable locally advanced or metastatic gastric or esophagogastric unction adenocarcinoma
MedDRA version: 12.1Level: LLTClassification code 10063916Term: Metastatic gastric cancer

Registration Number: EUCTR2008-001605-42-HU

Lead Sponsor: Amgen Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 138

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
• Before any study-specific procedure, the appropriate written informed consent
must be obtained (see Section 12.1)
4.1.4 Laboratory
• Hemoglobin = 9 g/dL (can be post-transfusion)
• 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/minute (calculated or measured)
• Aspartate aminotransferase (AST) and alanine amino transferase (ALT) = 2.5 x
ULN (OR AST and ALT = 5.0 x ULN in the presence of liver metastasis)
• Total bilirubin = 1.5x ULN
• Partial thromboplastin time (PTT) = 1.5 x ULN and international normalized ratio
(INR) = ULN
4.1.5 General
• Plan to begin protocol specific therapy within 7 days after enrollment or
randomization
• Able to tolerate infusions and take oral medications
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

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
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
• Known peripheral neuropathy > grade 1
• Known dihydropyrimidine dehydrogenase deficiency (DPD)
• 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
• History of any medical condition that in the opinion of the investigator, may
increase the risks associated with study participation or study treatments or may
interfere with the conduct of the study or interpretation of study results
• Major surgical procedure = 30 days before enrollment or randomization or not yet
recovered from prior major surgery
• Minor surgery (e,g. catheter or gastrostomy tube placement) =14 days before
enrollment or randomization or not yet recovered from prior minor surgery;
although placement of central venous access device, fine needle aspiration,
thoracentesis, endoscopic biliary stent or paracentesis = 1 day before enrollment
or randomization is acceptable
• Subjects with resectable disease or suitable for definitive chemoradiation
• Plans for surgical resection based on response to protocol therapy
• Subjects who have persistent gastric outlet obstruction, complete dysphagia or
are dependent upon jejunostomy for feeding.
• 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
4.2.2 Cardiac
• LVEF < 50% as determined by either MUGA scan or ECHO
• Clinically significant (i.e. active) cardiac disease or myocardial infarction within
the last 12 months before enrollment or randomization. Patients with any history
of clinically significant cardiac failure are excluded from study entry
4.2.3 Other abnormal medical conditions
• Serious or non-healing wound
• Known positive test for HIV, hepatitis C, chronic or active hepatitis B
• Presence of peripheral edema > Grade 2
• Thrombosis or vascular ischemic events within the last twelve months, such as deep venous thrombosis, pulmonary embolism, transient ischemic attack, cerebral infarction, or myocardial infarction.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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