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

May 5, 2026 updated by: Yi-Chin Fong, China Medical University Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an investigator-initiated, single-center clinical trial evaluating the safety and efficacy of ALK inhibitors in patients with locally advanced or metastatic bone cancer harboring truncated ALK (ALKATI) alterations. This molecular subtype has been associated with poor prognosis and limited response to conventional therapies.

Preclinical studies conducted by the study team have demonstrated that ALK inhibitors, including crizotinib (Xalkori®) and alectinib (Alecensa®), exhibit antitumor activity against bone cancer cells with truncated ALK expression. Based on these findings, this study aims to explore their therapeutic potential in a clinical setting.

Eligible patients are those who have experienced disease progression after standard treatment or have no appropriate standard treatment options available. Participants will receive oral ALK inhibitor therapy, with treatment selection and dose adjustments determined by the investigators based on clinical response and tolerability.

The primary objective of this study is to evaluate antitumor activity in this rare molecular subset of bone cancer. Secondary objectives include safety, tolerability, and clinical outcomes.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • China Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 20 years.
  • Patients with locally advanced or metastatic solid tumors harboring deficiency or alteration of anaplastic lymphoma kinase (ALK) tyrosine kinase.
  • Disease progression during or within 6 months after completion of standard therapy, or no appropriate standard treatment available.
  • At least one measurable lesion according to applicable response evaluation criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Estimated life expectancy of at least 8 weeks.

Exclusion Criteria:

  • Known hypersensitivity to crizotinib or alectinib.
  • Current or prior use of ALK inhibitors.
  • Current use of tyrosine kinase inhibitors.
  • Receipt of radiotherapy within 2 weeks prior to study entry. Palliative radiotherapy to non-target lesions is permitted.
  • History of other malignancies, except for osteosarcoma or chondrosarcoma, unless the patient has been disease-free for at least 2 years. Exceptions include adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
  • Liver cirrhosis with a Child-Pugh score ≥ 8.
  • Uncorrectable electrolyte abnormalities.
  • Presence of brain metastases.
  • Active acute infection.
  • Significant unresolved toxicity from prior therapy.
  • Comorbid conditions that may interfere with study participation, including but not limited to uncontrolled diabetes mellitus, autoimmune diseases, or any condition that, in the investigator's judgment, renders the patient unsuitable for the study.
  • Concurrent malignancy, unless it is adequately treated carcinoma in situ or basal cell carcinoma, or a malignancy that has been treated and has remained recurrence-free for at least 3 years.
  • Pregnant or breastfeeding women.
  • Patients with psychiatric disorders that may impair compliance with study requirements.
  • Current use of strong inducers or inhibitors of CYP3A enzymes, or use of other investigational or non-approved drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALK Inhibitor Treatment
Alectinib: 450 mg/day, administered orally, three times daily (one capsule per dose).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to 24 weeks (or every 8-12 weeks per imaging assessment)
Objective response rate, defined as the proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.
Up to 24 weeks (or every 8-12 weeks per imaging assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Study Director: Department of Orthopedics, China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

January 15, 2029

Study Completion (Estimated)

April 14, 2029

Study Registration Dates

First Submitted

April 24, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH115-REC2-048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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