Investigator-initiated clinical Trial of Alectinib in Patients with ALK positive rare cancer - TACKLE

ational Cancer Center Hospital0 个研究点目标入组 26 人开始时间: 2018年7月20日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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 1.
•6.at least one mesurable lesion.
•7.blood test findings meet requirements as follows
•1)Neutrophils >/= 1500/mm3
•2)Platelet count >/= 100000/mm3
•3)Hemoglobin >/= 8.0 g/dL
•4)AST =/< 90 U/L
•5)ALT =/< 126U/L (male), 69U/L(female)
•6)Total bilirubin =/< 1.5 mg/dL
•7)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

•(1) Active double cancer; synchronous or metachronous within 5years. Patients with carcinoma in situ are eligible
•2) Infections requiring systemic therapy
•3) Active gastrointestinal ulcer
•4) Interstitial pneumonia and/or pulmonary fibrosis diagnosed by chest CT imaging or clinical examinations
•5) HIV antibody positive,HTLV-1 antibody positive, HBs antigen positive, HCV antibody positive(HCV RNA negative patients are eligible)
•6) HBV-DNA positive
•7) Pregnant or breast-feeding women, or women suspected of being pregnant
•8) Mental disease interfering taking part in the trial

发起方