Clinical trial · Interventional
Treatment of Truncated ALK-positive Bone Cancer Using Crizotinib (Xalkori) or Alectinib (Alecensa)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Cancer | Malignant Bone Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alectinib | Drug | Alectinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ALK Inhibitor Treatment
- description
- Alectinib: 450 mg/day, administered orally, three times daily (one capsule per dose).
- interventionNames
- Drug: Alectinib
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Up to 24 weeks (or every 8-12 weeks per imaging assessment)
- description
- Objective response rate, defined as the proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available