CTRI/2021/07/034739进行中（未招募）2 期
A Phase 2 Basket Study of the Oral TRK Inhibitor Larotrectinib in Subjects With NTRK Fusion-positive Tumors - NAVIGATE
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
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
- •Locally advanced or metastatic non-secretory breast cancer, lung cancer, melanoma, and colorectal cancer with unknown human neurotrophic tyrosine receptor kinase 1 (NTRK1), NTRK2, or NTRK3 fusion status.
- •Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy.
- •Subjects must have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
排除标准
- •Prior progression while receiving approved or investigational tyrosine kinase
- •inhibitors targeting TRK. Subjects who received less than 28 days of treatment and
- •discontinued because of intolerance or toxicity are eligible.
- •Symptomatic or unstable brain metastases. (Note: Subjects with asymptomatic brain
- •metastases are eligible to participate in the study.) Subjects with primary CNS tumors
- •are eligible.
- •Unstable cardiovascular disease
研究者
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