Registry for Molecular Testing, Treatment and Outcome of Patients With Solid Tumors Harboring a NTRK Gene Fusion

NTRK Family Gene Mutation Clinical Trial

— REALTRK  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04557813
• Other study ID #: IOM-040444
• Status: Active, not recruiting
• Start date: December 2, 2020
• Est. completion date: October 25, 2026

Study information

• Verified date: February 2024
• Source: iOMEDICO AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

The REALTRK registry will provide data on treatment reality of patients with locally advanced or metastatic solid tumors harboring NTRK1, NTRK2 or NTRK3 gene fusions, thereby generating real world evidence. It will identify factors that influence treatment decisions after receiving the diagnosis of a NTRK (Neurotrophic Tyrosine Receptor Kinase) fusion-positive cancer. All treatment lines administered before and after the molecular diagnosis of a NTRK fusion-positive cancer, irrespective of the type of antineoplastic treatment, will be documented. Data will be assessed at least 36 months per patient (i.e. until 36 months after inclusion of the last patient in the study). This approach will allow a description of TRK fusion protein-targeted therapies and other therapy strategies regarding effectiveness and disease-related symptomology within the limitations of non-randomized studies in terms of comparative analyses. Intra-individual and inter-individual comparisons (for the latter, provided that a sufficient number of patients with a NTRK fusion-positive cancer are not treated with a TRK inhibitor) could be performed. The associated biomarker profiling module of the REALTRK registry will aim to set up a decentralized biobank for future research on molecular alterations.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• NTRK Family Gene Mutation

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
iOMEDICO AG	Roche Pharma AG

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

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