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

5. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

10

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Taiwan
      • Taichung, Taiwan
        • China Medical University Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: ALK Inhibitor Treatment
Alectinib: 450 mg/day, administered orally, three times daily (one capsule per dose).
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Objective Response Rate (ORR)
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

China Medical University Hospital

Etterforskere

  • Studieleder: Department of Orthopedics, China Medical University Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. mai 2026

Primær fullføring (Antatt)

15. januar 2029

Studiet fullført (Antatt)

14. april 2029

Datoer for studieregistrering

Først innsendt

24. april 2026

Først innsendt som oppfylte QC-kriteriene

24. april 2026

Først lagt ut (Faktiske)

1. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CMUH115-REC2-048

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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