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JOURNAL ONKOLOGIE – STUDIE
REALTRK

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

Rekrutierend

NCT-Nummer:
NCT04557813

Studienbeginn:
Dezember 2020

Letztes Update:
12.01.2021

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
iOMEDICO AG

Collaborator:
Roche Pharma AG

Studienleiter

Benjamin Kasenda, PD Dr. Dr.
Study Director
iOMEDICO AG, Ellen-Gottlieb-Str. 19, 79106 Freiburg, Germany

Kontakt

Studienlocations
(3 von 5)

Praxis für interdisziplinäre Onkologie & Hämatologie
79110 Freiburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Matthias Zaiss, MD
E-Mail: info@onkologie-freiburg.de
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed 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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Patients with locally advanced or metastatic solid tumor with a documented NTRK gene

fusion

- Criteria according to the current SmPCs of the used TRK inhibitors

- Age ≥ 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

- Participation in a clinical trial at enrolment

Studien-Rationale

Primary outcome:

1. Overall response rate (Time Frame - 36 months):
Proportion of patients with CR or PR as best response



Secondary outcome:

1. Patient and disease characteristics (Time Frame - 36 months):
Descriptive summary of demographics, patient and disease characteristics

2. Test methods used for diagnosis of a NTRK fusion-positive cancer (Time Frame - Day 1):
Description of test methods used for diagnosis of a NTRK fusion-positive cancer and results thereof

3. Physician-reported factors affecting decision to test for NTRK fusion and treatment decision (Time Frame - Day 1):
Description of physician-reported factors affecting decision to test for NTRK fusion and treatment decision making after diagnosis of NTRK gene fusion

4. Treatment reality after diagnosis of NTRK gene fusion (Time Frame - 36 months):
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.

5. Safety of TRK inhibitor treatments (Time Frame - 36 months):
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.

6. Physician-reported evaluation of TRK inhibitor therapy (Time Frame - Day 1):
Description of physician-reported evaluation of TRK inhibitor therapy

7. Disease-related symptoms (Time Frame - 36 months):
Description of courses of disease-related symptoms (weight loss, ECOG) after diagnosis of NTRK gene fusion (Only for patients of inclusion group I)

8. Disease control rate (Time Frame - 36 months):
Proportion of patients with CR, PR or SD as best response

9. Time to Response (Time Frame - 36 months):
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

10. Duration of Response (Time Frame - 36 months):
Time from documentation of tumor response to disease progression or death from any cause

11. Progression-free survival (Time Frame - 36 months):
Time from start of treatment until disease progression or death

12. Overall Survival (Time Frame - 36 months):
Time from start of treatment until death of any cause

13. PFS ratio (Time Frame - 36 months):
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

14. Event-free survival (Time Frame - 36 months):
Time from start of treatment until PD or death

Studien-Arme

  • IC before start of any treatment
    Informed consent (IC) before start of any treatment after diagnosis of NTRK fusion-positive cancer. All data after diagnosis of NTRK fusion-positive cancer are collected prospectively.
  • IC after start of any treatment
    IC after start of any treatment after diagnosis of NTRK fusion-positive cancer. Data after study inclusion are collected prospectively and retrospectively.
  • Deceased patients
    Patients deceased prior to study inclusion (no IC required). All data are collected retrospectively.

Quelle: ClinicalTrials.gov


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