NTRK Family Gene Mutation Clinical Trial
— REALTRKOfficial title:
Registry for Molecular Testing, Treatment and Outcome of Patients With Locally Advanced or Metastatic Solid Tumors Harboring a Fusion of NTRK1, NTRK2 or NTRK3
Verified date | February 2024 |
Source | iOMEDICO AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The objective of this registry is to analyze treatment reality and outcome of patients with locally advanced or metastatic solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3
Status | Active, not recruiting |
Enrollment | 88 |
Est. completion date | October 25, 2026 |
Est. primary completion date | October 25, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Locally advanced or metastatic solid tumor with a documented NTRK gene fusion, based on a validated assay (according to current ESMO recommendations), or the provision of tumor material for central retesting - Molecular pathology or molecular diagnostics report with details on NTRK gene fusion testing must be available - Aged = 18 years - Signed and dated informed consent form (ICF) (only if patient is alive at time of data entry into the project; not applicable for inclusion of deceased patients' data) Exclusion Criteria: - Treatment with a TRK inhibitor prior to Sept 19th, 2019 (Germany) or May 28th, 2020 (Switzerland) - Participation in a clinical trial with a TRK inhibitor before or at enrolment (liv-ing patients) or before inclusion (deceased patients) - Deceased patients who have explicitly contradicted further use of data |
Country | Name | City | State |
---|---|---|---|
Germany | Onkologische Schwerpunktpraxis Kurfürstendamm | Berlin | |
Germany | Centrum für Hämatologie und Onkologie Bethanien | Frankfurt | |
Germany | Praxis für interdisziplinäre Onkologie & Hämatologie | Freiburg | |
Germany | Asklepios Klinik Altona | Hamburg | |
Germany | Gemeinschaftspraxis | Hannover | |
Germany | Onkologische Schwerpunktpraxis | Hannover | |
Germany | SLK Kliniken Heilbronn Klinik für Innere Medizin III | Heilbronn | |
Germany | Klinikum Kempten | Kempten | |
Germany | PIOH - Praxis Internistische Onkologie und Hämatologie | Köln | |
Germany | Asklepios MVZ Bayern, Schwerpunkt Hämatologie/Onkologie | Landsberg | |
Germany | Onkologische Praxis am Marien-Krankenhaus | Lübeck | |
Germany | Praxis für Onkologie | Mönchengladbach | |
Germany | Klinikum rechts der Isar der TUM Innere Medizin II | München | |
Germany | Universitätsklinikum Münster, Medizinische Klinik A | Münster | |
Germany | TZN - Tumorzentrum Niederrhein GmbH | Neuss | |
Germany | Studienzentrum Onkologie Ravensburg | Ravensburg | |
Germany | Praxis und Tagesklinik für Onkologie und Hämatologie | Recklinghausen | |
Germany | Klinikum Rosenheim | Rosenheim | |
Germany | Zentrum Ambulante Onkologie | Schorndorf | |
Germany | MVZ Kloster Paradiese GbR | Soest | |
Germany | MVZ für Hämatologie und Onkologie | Ulm | |
Germany | Onkologie Schwarzwald-Alb | Villingen-Schwenningen | |
Switzerland | Universitätsspital Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
iOMEDICO AG | Roche Pharma AG |
Germany, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall response rate | Proportion of patients with CR or PR as best response | 36 months | |
Secondary | Patient and disease characteristics | Descriptive summary of demographics, patient and disease characteristics | 36 months | |
Secondary | Test methods used for diagnosis of a NTRK fusion-positive cancer | Description of test methods used for diagnosis of a NTRK fusion-positive cancer and results thereof | Day 1 | |
Secondary | Physician-reported factors affecting decision to test for NTRK fusion and treatment decision | Description of physician-reported factors affecting decision to test for NTRK fusion and treatment decision making after diagnosis of NTRK gene fusion | Day 1 | |
Secondary | Treatment reality after diagnosis of NTRK gene fusion | Description of all treatment lines given to the patient after diagnosis of NTRK gene fusion including: Type of treatment (Systemic TRK inhibitor treatments or Non-TRK inhibitor treatments), treatment duration, dosing, treatment modifications and reasons thereof, reasons for end of treatment. | 36 months | |
Secondary | Safety of TRK inhibitor treatments | Treatment-emergent AEs (i.e., AEs which occurred during a specific TRK inhibitor treatment and in the respective survival FU) will be calculated per patient (absolute and relative frequencies) and case-based (absolute frequencies). The occurrence of any (S)AE will be displayed overall and per CTCAE grade. Adverse drug reactions (ADRs) and AESIs will be displayed accordingly.
Incidence of AEs (MedDRA Preferred Term (PT) by System Organ Class (SOC)) will be calculated accordingly for each type of AE/ADR. |
36 months | |
Secondary | Physician-reported evaluation of TRK inhibitor therapy | Description of physician-reported evaluation of TRK inhibitor therapy | Day 1 | |
Secondary | Disease-related symptoms | Description of courses of disease-related symptoms (weight loss, ECOG) after diagnosis of NTRK gene fusion (Only for patients of inclusion group I) | 36 months | |
Secondary | Disease control rate | Proportion of patients with CR, PR or SD as best response | 36 months | |
Secondary | Time to Response | Time from start of treatment to the first objective tumor response (e.g., tumor shrinkage of =30%) observed for patients who achieved a CR or PR | 36 months | |
Secondary | Duration of Response | Time from documentation of tumor response to disease progression or death from any cause | 36 months | |
Secondary | Progression-free survival | Time from start of treatment until disease progression or death | 36 months | |
Secondary | Overall Survival | Time from start of treatment until death of any cause | 36 months | |
Secondary | PFS ratio | ratio of PFS of the first treatment line with a TRK inhibitor to time to progression (TTP) in the preceding treatment line without a TRK inhibitor | 36 months | |
Secondary | Event-free survival | Time from start of treatment until PD or death | 36 months |
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