Clinical trial · Observational
Retrospective Analysis of the Experience With Larotrectinib in Patients With Solid Neoplasms With NTRK Fusion in Spain (SPAINTRK)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Neoplasms With NTRK Fusions | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Cancer patients with solid neoplasms with NTRK fusions.
- description
- 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.
Primary outcomes (1)
- measure
- Duration of Response (DoR)
- timeFrame
- Throughout the study period, an average of 3 year
- description
- Duration of response (DoR): is defined as the time from first confirmed response (complete (CR) or partial (PR) response), according to Objective response rate (ORR) defined below, to the date of the documented progression of the disease (PD) as determined using RECIST V1.1 criteria or death due to any cause, whichever occurs first. Those patients with response and without PD or death event will be censored on the date of their last tumor assessment.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available