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NOT YET RECRUITING
NCT07560410
PHASE1/PHASE2

Treatment of Truncated ALK-positive Bone Cancer Using Crizotinib (Xalkori) or Alectinib (Alecensa)

Sponsor: China Medical University Hospital

View on ClinicalTrials.gov

Summary

This is an investigator-initiated, single-center clinical trial evaluating the efficacy and safety of ALK inhibitors in patients with locally advanced or metastatic bone cancer harboring truncated ALK (ALKATI) alterations. Eligible patients must have disease progression after standard therapy or no suitable standard treatment options. Participants will receive either crizotinib (Xalkori®) or alectinib (Alecensa®), with treatment selection determined by the study investigators. The study aims to assess antitumor activity, safety, and clinical outcomes in this rare molecular subtype of bone cancer.

Key Details

Gender

All

Age Range

20 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-05-15

Completion Date

2029-04-14

Last Updated

2026-05-11

Healthy Volunteers

No

Conditions

Interventions

DRUG

Alectinib

Patients will receive oral anaplastic lymphoma kinase (ALK) inhibitor therapy for locally advanced or metastatic bone cancer harboring truncated ALK (ALKATI) alterations. Treatment will include alectinib. The dosing regimen of alectinib, including starting dose and any subsequent adjustments, will be determined by the investigators based on clinical response and tolerability. Each treatment cycle is defined as 4 weeks. Drug selection and dose modifications will be at the discretion of the investigators. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal from the study.

Locations (1)

China Medical University Hospital

Taichung, Taiwan