CTRI/2009/091/000149已完成1 期
A Phase 1b/2 Trial of AMG 479 or AMG 102 in Combination With Platinum-Based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 204
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Key Exclusion Criteria
- •Prior chemotherapy, chemoradiation, or investigational agent for SCLC
- •Prior radiotherapy to >25% of the bone marrow
- •Symptomatic or untreated central nervous system metastases (with exceptions)
- •Currently or previously treated with biologic, immunologic or other therapies for SCLC
- •Current serious or nonhealing wound or ulcer
- •History of prior concurrent other malignancy (with exceptions)
- •Thorombosis or vascular ischemic events within the last 12 months such as DVT, PE, TIA or MI
- •Any clinically significant medical condition other than cancer (eg, cardiovascular disease or COPD), which could interfere with the safe delivery of study treatment or risk of toxicity
排除标准
- •Key Exclusion Criteria
- •Prior chemotherapy, chemoradiation, or investigational agent for SCLC
- •Prior radiotherapy to 25% of the bone marrow
- •Symptomatic or untreated central nervous system metastases (with exceptions)
- •Currently or previously treated with biologic, immunologic or other therapies for SCLC
- •Current serious or nonhealing wound or ulcer
- •History of prior concurrent other malignancy (with exceptions)
- •Any clinically significant medical condition other than cancer (eg, cardiovascular disease or chronic obstructive pulmonary disease), which could interfere with the safe delivery of study treatment or risk of toxicity
研究者
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A Phase 1b/2 Trial of AMG 479 or AMG 102 in Combination With Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung CancerPreviously Untreated Extensive Stage Small Cell Lung Cancer (SCLC)MedDRA version: 14.1Level: LLTClassification code 10041067Term: Small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-003292-42-HUAmgen Inc213
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A Phase 1b/ 2 Trial of AMG 479 or AMG 102 in Combination with Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung CancerEUCTR2008-003292-42-NLAmgen Inc288
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A Phase 1b/2 Trial of AMG 479 or AMG 102 in Combination With Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung CancerPreviously Untreated Extensive Stage Small Cell Lung Cancer (SCLC)MedDRA version: 14.1Level: LLTClassification code 10041067Term: Small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-003292-42-PLAmgen Inc213