Klinik und Poliklinik für Kinder- und Jugendmedizin

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Kinderonkologie und —hämatologie - ON-TRK - PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib

PrüfplancodeISRCTNEudraCTClinicaltrials.govDRKS
ON-TRKNCT04142437

Status: Aktiv

Studienziel / Fragestellung

Primäres Prüfziel

The primary objective of this international, non-interventional study is to describe the safety of larotrectinib in patients with locally advanced or metastatic TRK fusion cancer, including incidences of all treatment-emergent adverse events (TEAEs) in real-world practice conditions.

Sekundäre Prüfziele

• To describe the effectiveness of larotrectinib, including overall response rate (ORR), disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), and overall survival (OS) by local investigator assessments.
• To describe the patterns of larotrectinib treatment, including actual doses, duration of treatment (DOT), and other dosing parameters
• To describe the effectiveness of larotrectinib in subgroups of patients, including but not limited to: by age, NTRK gene, NTRK gene partner, testing methodology, country/region, prior therapy (type and/or number of lines of therapy), and/or by other patient (baseline) characteristics. Additional subgroups may be explored as needed
• To describe long-term effects of larotrectinib on growth (height and weight), neurological outcomes, developmental milestones, and sexual development (Tanner scale) in the pediatric cohort.
• To describe HRQoL of larotrectinib treated patients by PROs in Austria, Canada and Germany

Diagnose

  • Hirntumore
  • Kinderonkologie und -hämatologie
  • Solide Tumoren

Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion.

Patientenmerkmale

Einschlusskriterien

• Adult and pediatric (from birth to 18 year old) patients
• Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified locally. Acceptable methods of detection of NTRK gene fusion include NGS, fluorescence in situ hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any other genomic testing able to detect NTRK gene fusion. If a pan-TRK IHC method is used, this result needs to be accompanied with the results using one of the other methods noted above.
• Life expectancy of at least 3 months based on clinical judgement
• Decision to treat with larotrectinib made by the treating physician prior to study enrollment
• Signed informed consent form
• For patients under legal age, signed assent by the patient (where applicable) and
parental/legal guardian signed informed consent is required

Ausschlusskriterien

• Any contraindications as listed in the local approved product information
• Pregnancy
• Participation in an investigational program with interventions outside of routine clinical practice
• Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition
• Patients with NTRK gene amplification or NTRK point mutation

Studiendesign

Phase IV, Multizentrisch, Prospektiv, Einarmig, Open Label

Dokumente (passwortgeschützt)

(noch keine Dokumente)

Prüfzentren

Köln

Klinik und Poliklinik für Kinder- und Jugendmedizin

Studienbüro

    Early Clinical Trials

Status

Aktiv

Prüfer (Hauptprüfer im Zentrum)

Prof. Dr. med. Matthias Fischer

Stellvertretender Prüfer

  • Dr. med. Boris Decarolis

Studienkontakt im Prüfzentrum