JOURNAL ONKOLOGIE – STUDIE
REALTRK
Benjamin Kasenda, PD Dr. Dr.
Study Director
iOMEDICO AG, Ellen-Gottlieb-Str. 19, 79106 Freiburg, Germany
Beate Niemeier, Dr.
Kontakt:
Phone: +49/76115242
E-Mail: realtrk@iomedico.com» Kontaktdaten anzeigen
Studienlocations
Onkologische Schwerpunktpraxis Kurfürstendamm
10707 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Ingo Schwaner, MD
E-Mail: ingo.schwaner@onkologie-kurfuerstendamm.de» Ansprechpartner anzeigen Praxis für interdisziplinäre Onkologie & Hämatologie
79110 Freiburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Matthias Zaiss, MD
E-Mail: info@onkologie-freiburg.de» Ansprechpartner anzeigen Onkologische Schwerpunktpraxis
30161 Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Eyck von der Heyde, MD
E-Mail: info@onkologie-am-raschplatz.de» Ansprechpartner anzeigen Zentrum Ambulante Onkologie
73614 Schorndorf
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Dieter Bürkle, MD
E-Mail: buerkle@onkologie-rems-murr.de» Ansprechpartner anzeigen MVZ Kloster Paradiese GbR
59494 Soest
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Anke Wortmann, MD
E-Mail: dr.wortmann@onkologie-soest.de» Ansprechpartner anzeigen Alle anzeigen
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.
- 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
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
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
Study Director
iOMEDICO AG, Ellen-Gottlieb-Str. 19, 79106 Freiburg, Germany
Kontakt
Kontakt:
Phone: +49/76115242
E-Mail: realtrk@iomedico.com» Kontaktdaten anzeigen
Studienlocations
(3 von 5)
10707 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Ingo Schwaner, MD
E-Mail: ingo.schwaner@onkologie-kurfuerstendamm.de» Ansprechpartner anzeigen
79110 Freiburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Matthias Zaiss, MD
E-Mail: info@onkologie-freiburg.de» Ansprechpartner anzeigen
30161 Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Eyck von der Heyde, MD
E-Mail: info@onkologie-am-raschplatz.de» Ansprechpartner anzeigen
73614 Schorndorf
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Dieter Bürkle, MD
E-Mail: buerkle@onkologie-rems-murr.de» Ansprechpartner anzeigen
59494 Soest
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Anke Wortmann, MD
E-Mail: dr.wortmann@onkologie-soest.de» Ansprechpartner 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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