Analyzing the use of Larotrectinib for solid tumors with NTRK fusions in Spain
Retrospective Analysis of the Experience With Larotrectinib in Patients With Solid Neoplasms With NTRK Fusion in Spain (SPAINTRK)
This study looks at how well Larotrectinib works for Spanish patients with solid tumors that have NTRK fusions to help find better treatment options for these rare cancers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 19 (estimated) |
| Sex | All |
| Sponsor | Grupo Espanol de Tumores Neuroendocrinos Academic / other |
| Drugs / interventions | Larotrectinib, Larotrebtinib |
| Locations | 14 sites (Torrevieja, Alicante and 13 other locations) |
| Trial ID | NCT06837090 on ClinicalTrials.gov |
What this trial studies
SPAINTRK is an observational retrospective analysis that collects data on Spanish patients with solid neoplasms treated with Larotrectinib through a compassionate use program. The study aims to evaluate the effectiveness of Larotrectinib in patients with confirmed NTRK fusions, contributing to the selection of optimal treatments for these cancers. By analyzing patient outcomes, the study seeks to enhance understanding of responses to this novel therapy in a real-world setting. The data collected will help inform future treatment strategies for rare cancers associated with NTRK fusions.
Who should consider this trial
Good fit: Ideal candidates include infants and adults with confirmed solid neoplasms and detected NTRK fusions who have been treated with Larotrectinib under compassionate use.
Not a fit: Patients who have received Larotrectinib in clinical trials or after its commercialization will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Larotrectinib, potentially improving treatment options for patients with NTRK fusion-positive solid tumors.
How similar studies have performed: Other studies have shown promising results with Trk inhibitors like Larotrectinib, indicating a potential for success in this observational analysis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Infant and adult patients (all ages). 2. Patients with confirmed diagnosis of solid neoplasms. 3. Patients must have detected NTRK fusions by the following diagnostic methods NGS, fluorescence in situ hybridization (FISH) and/or Immunohistochemistry (IHC). 4. Patients must be treated with Larotrectinib under the compassionate use program (before the commercialization) in order to be included in the study. 5. Data should be available in order to evaluate effectiveness and consequent follow up. Exclusion Criteria: 1. Patients with solid neoplasms treated with Larotrectinib in clinical trials or other settings different from clinical practice. 2. Patients that initiated treatment with Larotrectinib after the obtention of prize-reimbursement and commercialization
Where this trial is running
Torrevieja, Alicante and 13 other locations
- Hospital Quirón Salud Torrevieja — Torrevieja, Alicante, Spain (Recruiting)
- Hospital Universitario Son Espases — Palma, Baleres, Spain (Not_yet_recruiting)
- Hospital San Joan de Deu — Esplugues de Llobregat, Barcelona, Spain (Recruiting)
- Hospital Universitario de Cruces — Barakaldo, Bizkaia, Spain (Not_yet_recruiting)
- Hospital Universitario Marqués de Valdecilla — Santander, Cantabria, Spain (Recruiting)
- Hospital Clínico Santiago de Compostela — Santiago de Compostela, La Coruña, Spain (Recruiting)
- Hospital Universitario Insular de Gran Canaria — Las Palmas de Gran Canaria, Las Palmas, Spain (Recruiting)
- Hospital Universitario Infanta Sofía — San Sebastian de los Reyes, Madrid, Spain (Recruiting)
- Hospital Universitario de Navarra — Pamplona, Navarra, Spain (Recruiting)
- Hospital Universitario Vall d'Hebron — Barcelona, Spain (Recruiting)
- Hospital Clinic de Barcelona — Barcelona, Spain (Recruiting)
- Hospital Universitario Lucus Augusti — Lugo, Spain (Recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
- Hospital Universitario La Paz — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: A responsible person designated by the sponsor, M.D., PhD.
- Email: investigacio@mfar.net
- Phone: +34 93 434 44 12
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.