| Title |
Prospective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib |
| Protocole ID |
20324 |
| ClinicalTrials.gov ID |
NCT04142437 |
| Cancer Type(s) |
Solid Tumors |
| Phase |
Other |
| Stage |
|
| Study Type |
Other |
| Drug |
|
| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 CHUL ET CENTRE MERE-ENFANT SOLEIL
2705 boulevard Laurier, Québec, QC, G1V 4G2
|
| City |
|
| Principal Investigator |
Dr. Valérie Larouche
|
| Coordinator |
Panagiota Giannakouros
418-525-4444 poste 40121
|
| Status |
Recruiting |
| Activation Date |
|
| Eligibility Criteria |
- 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
|
| Exclusion Criteria |
- 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
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| |
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Groupe d'étude en oncologie du Québec