jRCT2091220364招募中不适用
Investigator-initiated clinical Trial of Alectinib in Patients with ALK positive rare cancer (TACKLE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 主要终点
- -
研究概览
简要总结
暂无简介。
入排标准
- 年龄范围
- 7month old over 至 No limit（—）
入选标准
- •1.registered in MASTER KEY Registory study.
- •2.ALK alteration (rearrangement or active mutation or copy number gain) is confermed in FoundationOne inspection.
- •3.metastatic, unresectable, orrecurrent cancer.
- •4.no standard treatment is available, or first line treatment was invalid.
- •5.Performance Status (ECOG) 0 or
- •6.at least one mesurable lesion.
- •7.blood test findings meet requirements as follows
- •Neutrophils >/= 1500/mm3
- •Platelet count >/= 100000/mm3
- •Hemoglobin >/= 8.0 g/dL
- •AST =/< 90 U/L
- •ALT =/< 126U/L (male), 69U/L(female)
- •Total bilirubin =/< 1.5 mg/dL
- •Serum creatinine =/< 0.6mg/dL(7mo-24mo), 0.8 mg/dL(2-5yo),1.0 mg/dL(6-9yo),1.2 mg/dL(10 and older)
- •8.consented to contraception during treatment.
- •9.written consent was obtained
排除标准
- •(1) Active double cancer; synchronous or metachronous within 5years. Patients with carcinoma in situ are eligible
- •Infections requiring systemic therapy
- •Active gastrointestinal ulcer
- •Interstitial pneumonia and/or pulmonary fibrosis diagnosed by chest CT imaging or clinical examinations
- •HIV antibody positive,HTLV-1 antibody positive, HBs antigen positive, HCV antibody positive(HCV RNA negative patients are eligible)
- •HBV-DNA positive
- •Pregnant or breast-feeding women, or women suspected of being pregnant
- •Mental disease interfering taking part in the trial
结局指标
主要结局
-
Objective response rate (central review)
次要结局
未报告次要终点
研究者
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