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

Clinical Trial of Alectinib in Patients with ALK positive rare cancer

Yasushi Goto

National Cancer Center Hospital

5-1-1 Tukiji, Chuo-ku, Tokyo, 104-0045

ygoto@ncc.go.jp

NCCH1712/MK003 Clinical Trial Coordinating Office

National Cancer Center Hospital

5-1-1 Tukiji, Chuo-ku, Tokyo, 104-0045

+81-3-3542-2511

NCCH1712_office@ml.res.ncc.go.jp

RECRUITING

July. 24, 2018

Interventional

Single arm phase 2 trial

open(masking not used)

No

2

1.registered in MASTER KEY Registory study.
2.ALK alteration (fusion / 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 >/= 9.0 g/dL
4)AST =/< 100 U/L
5)ALT =/< 100U/L
6)Total bilirubin =/< 1.5 mg/dL
7)Serum creatinine =/< 0.5mg/dL(0-6mo), 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
10. Body weight >/=7kg
* The target age for the study is currently under 15 years old and younger.

(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, 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

Both

Rare cancers harboring ALK gene alterations

Intervention type:DRUG Name of intervention:Alectinib Dose form / Japanese Medical Device Nomenclature:CAPSULE Route of administration / Site of application:ORAL Dose per administration:20-300 mg Dosing frequency / Frequency of use:OTHER, SPECIFY twice daily or once daily (dose depends on age and weight) Planned duration of intervention:Until patient meets protocol treatment discontinuation criteria Intended dose regimen:Alectinib monotherapy detailes of teratment arms:Patients are administered alectinib monotherapy until they meet treatment discontinuation criteria

malignant solid tumors

D009369

Objective response rate (central review)

Objective response rate (investigator assessed), disease control rate, progression-free survival, overall survival, safety

+81-3-3542-2511

July. 03, 2018