EUCTR2008-001605-42-ES进行中（未招募）不适用
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.-----------------------------------------------------------Estudio multicéntrico, a doble ciego, de 3 brazos y de fases 1b/2 en sujetos con adenocarcinoma gástrico o de la unión gastroesofágica metastásico o localmente avanzado no resecable para evaluar la seguridad y la eficacia del tratamiento de primera línea con epirubicina, cisplatino y capecitabina (ECX) junto con AMG 102.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 138
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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 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
- •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
研究者
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