Retrospective Analysis of the Experience With Larotrectinib in Patients With Solid Neoplasms With NTRK Fusion in Spain (SPAINTRK)

Status: Recruiting
Location: See all (14) locations...
Study Type: Observational
SUMMARY

SPAINTRK aims to be the first trial in Spain to systematically collect data on outcomes of Spanish patients with solid neoplasms treated with Larotrectinib through the compassionate drug use program, during the time elapsed between the indication approval and the drug commercialization. This will contribute to selection of the best treatment for cancer patients with NTRK fusions, such as Trk inhibitors like Larotrectinib. Since the FDA and the EMA approved the use of Trk inhibitors, like Larotrectinib, there is a new and effective option of treatment for patients with NTRK fusions in solid neoplasms. This observational retrospective study will allow to analyze data of patients treated with Larotrectinib across the country and increase the knowledge on response to rare and different cancers Main objective is describe the effectiveness of Larotrectinib treatment in tumors with NTRK fusion in Spanish patients as a clinical series. This is an observational retrospective study including thyroid cancer patients with solid neoplasms with NTRK fusions. The study will use secondary data retrieved from medical records from each patient. The medical records include all the clinical variables defined in order to perform the analysis and it is not necessary to access additional sources.In total, 19 patients diagnosed with solid neoplasms that have been confirmed to bear NTRK fusions in their tumors will be included in the study. It is known that these patients have received the treatment with Larotrectinib in 14 centers in Spain, prior to treatment reimbursement in Spain.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Infant and adult patients (all ages).

• Patients with confirmed diagnosis of solid neoplasms.

• Patients must have detected NTRK fusions by the following diagnostic methods NGS, fluorescence in situ hybridization (FISH) and/or Immunohistochemistry (IHC).

• Patients must be treated with Larotrectinib under the compassionate use program (before the commercialization) in order to be included in the study.

• Data should be available in order to evaluate effectiveness and consequent follow up.

Locations
Other Locations
Spain
Hospital Universitario de Cruces
RECRUITING
Barakaldo
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Hospital San Joan de Deu
RECRUITING
Esplugues De Llobregat
Hospital Universitario Insular de Gran Canaria
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario Lucus Augusti
RECRUITING
Lugo
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Son Espases
COMPLETED
Palma
Hospital Universitario de Navarra
RECRUITING
Pamplona
Hospital Universitario Infanta Sofía
RECRUITING
San Sebastián De Los Reyes
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Hospital Clínico Santiago de Compostela
RECRUITING
Santiago De Compostela
Hospital Quirón Salud Torrevieja
RECRUITING
Torrevieja
Contact Information
Primary
A responsible person designated by the sponsor, M.D., PhD.
investigacio@mfar.net
+34 93 434 44 12
Time Frame
Start Date: 2025-02-11
Estimated Completion Date: 2026-01
Participants
Target number of participants: 19
Treatments
Thyroid cancer patients with solid neoplasms with NTRK fusions.
Thyroid cancer patients with solid neoplasms with NTRK fusions. The study will use secondary data retrieved from each patient's medical records. The clinical history includes all the clinical variables defined to perform the analysis and it is not necessary to access additional sources.~The assignment of a patient to a specific therapeutic strategy has already been decided in advance by the usual clinical practice of medicine; the decision to prescribe a specific treatment was clearly dissociated from the decision to include a patient in the study. No intervention, neither diagnostic nor follow-up, will be applied to patients other than usual clinical practice. Epidemiological methods will be used to analyze the data collected.
Related Therapeutic Areas
Sponsors
Leads: Grupo Espanol de Tumores Neuroendocrinos
Collaborators: Grupo Español de Tumores Neuroendocrinos y Endocrinos (GETNE), MFAR

This content was sourced from clinicaltrials.gov

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