Clinical Trial of Alectinib in Patients with ALK positive rare cancer

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2091220364

Enrollment

Registered

2018-07-20

Start date

2018-07-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rare cancers harboring ALK gene alterations malignant solid tumors

Interventions

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 Dosi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 =//=7kg * The target age for the study is currently under 15 years old and younger.

Exclusion criteria

Exclusion criteria: (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

Design outcomes

Primary

Measure	Time frame
Objective response rate (central review)	—

Secondary

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

Countries

Japan

Contacts

Public ContactNCCH1712/MK003 Clinical Trial Coordinating Office

National Cancer Center Hospital

NCCH1712_office@ml.res.ncc.go.jp+81-3-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026