NCT01524926已完成2 期
Cross-tumoral Phase 2 Clinical Trial Exploring Crizotinib (PF-02341066) in Patients With Advanced Tumors Induced by Causal Alterations of ALK and/or MET ("CREATE")
European Organisation for Research and Treatment of Cancer - EORTC25 个研究点 分布在 10 个国家目标入组 582 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 582
- 试验地点
- 25
- 主要终点
- Antitumor activity of crizotinib
研究概览
简要总结
The study will primarily assess the antitumor activity of crizotinib in a variety of tumors with alterations in ALK and/or MET pathways. The targeted patient population will include patients with tumors harboring specific alterations leading to ALK and/or MET activation, where tyrosine kinase inhibitors against these targets have not yet been adequately explored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Crizotinib in Anaplastic large cell lymphoma
Experimental
干预措施: Crizotinib (PF-02341066) (Drug)
Crizotinib in Inflammatory myofibroblastic tumor
Experimental
干预措施: Crizotinib (PF-02341066) (Drug)
Crizotinib in Papillary renal cell carcinoma type 1
Experimental
干预措施: Crizotinib (PF-02341066) (Drug)
Crizotinib in Clear cell sarcoma
Experimental
干预措施: Crizotinib (PF-02341066) (Drug)
Crizotinib in Alveolar soft part sarcoma
Experimental
干预措施: Crizotinib (PF-02341066) (Drug)
Crizotinib in Alveolar rhabdomyosarcoma
Experimental
干预措施: Crizotinib (PF-02341066) (Drug)
结局指标
主要结局
Antitumor activity of crizotinib
To study the antitumor activity of crizotinib across predefined tumor types in patients whose tumors are harboring specific alterations in ALK and/or MET
次要结局
- Correlative research endpoints
- Progression free survival
- Disease control rate
- Safety (reporting of adverse events according to CTCAE v4.0)
- Overall survival
- Duration of response
研究者
研究点 (25)
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不适用
Phase II clinical trial exploring the activity of crizotinib in patients with advanced solid tumors induced by causal alterations of specific receptors (ALK and MET/HGF receptor tyrosine kinases) expressed by cancer cellsocally advanced and/or metastatic malignant tumor (anaplastic large cell lymphoma, inflammatory myofibroblastic tumor, papillary renal cell carcinoma type 1, alveolar soft part sarcoma, clear cell sarcoma or alveolar rhabdomyosarcoma) deemed incurable by conventional surgery, radiotherapy, systemic therapy or any other means.MedDRA version: 15.0Level: LLTClassification code 10065867Term: Alveolar rhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.0Level: LLTClassification code 10067918Term: Inflammatory myofibroblastic tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.0Level: PTClassification code 10002227Term: Anaplastic large cell lymphoma T- and null-cell typesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.0Level: PTClassification code 10001882Term: Alveolar soft part sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.0Level: PTClassification code 10067946Term: Renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.0Level: LLTClassification code 10065865Term: Clear cell sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-001988-52-FREORTC582