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JOURNAL ONKOLOGIE – STUDIE
ON-TRK

Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body

Rekrutierend

NCT-Nummer:
NCT04142437

Studienbeginn:
April 2020

Letztes Update:
04.04.2024

Wirkstoff:
larotrectinib(Vitrakvi, BAY2757556)

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Bayer

Collaborator:
-

Kontakt

Bayer Clinical Trials Contact
Kontakt:
Phone: (+)1-888-84 22937
E-Mail: clinical-trials-contact@bayer.com» Kontaktdaten anzeigen

Studienlocations
(3 von 76)

Banner Desert Medical Center
85202 Mesa
United StatesZurückgezogen» Google-Maps
California Research Inst.
90027 Los Angeles
United StatesRekrutierend» Google-Maps
USC / Norris Comprehensive Cancer Center
90089 Los Angeles
United StatesZurückgezogen» Google-Maps
UCLA - Mattel Children's Hospital
90095 Los Angeles
United StatesRekrutierend» Google-Maps
Hoag Memorial Hospital Presbyterian
82663 Newport Beach
United StatesRekrutierend» Google-Maps
UCSF Benioff Children's Hospital Oakland
94609 Oakland
United StatesZurückgezogen» Google-Maps
Stanford Univ Med Ctr. / Lucile Packard Children's Hosp
94304 Palo Alto
United StatesRekrutierend» Google-Maps
Providence Health System - Southern California
90404 Santa Monica
United StatesAbgebrochen» Google-Maps
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
90502 Torrance
United StatesRekrutierend» Google-Maps
Nicklaus Children's Hospital
33155 Miami
United StatesRekrutierend» Google-Maps
Nemours Children's Hospital
32827 Orlando
United StatesZurückgezogen» Google-Maps
Fort Wayne Medical Oncology Hematology
46804 Fort Wayne
United StatesRekrutierend» Google-Maps
Regional Health Hope Center
47802 Terre Haute
United StatesZurückgezogen» Google-Maps
Cancer Center of Kansas
67214 Wichita
United StatesRekrutierend» Google-Maps
Univ. of Maryland / Greenebaum Comp. Cancer Ctr.
21201 Baltimore
United StatesZurückgezogen» Google-Maps
Johns Hopkins / Sidney Kimmel Cancer Center
21231 Baltimore
United StatesRekrutierend» Google-Maps
Frederick Health-James M Stockman Cancer Institute
21702 Frederick
United StatesRekrutierend» Google-Maps
Tufts / Neely Cancer Center
02111 Boston
United StatesRekrutierend» Google-Maps
Boston Children's / Dana Farber
02215 Boston
United StatesZurückgezogen» Google-Maps
Detroit Clinical Research Center
48334 Farmington Hills
United StatesRekrutierend» Google-Maps
Nevada Cancer Research Foundation
89169 Las Vegas
United StatesRekrutierend» Google-Maps
Atlantic Hem Onc / Morristown Medical Center
07960 Morristown
United StatesZurückgezogen» Google-Maps
Rutgers Cancer Institute of New Jersey
08901 New Brunswick
United StatesZurückgezogen» Google-Maps
Great Lakes Cancer Center
14210 Buffalo
United StatesAbgebrochen» Google-Maps
Memorial Sloan Kettering Children's Cancer Center
10065 New York
United StatesRekrutierend» Google-Maps
Staten Island Univ. Hospital (Northwell Health)
10305 Staten Island
United StatesRekrutierend» Google-Maps
Levine Cancer Center
28204 Charlotte
United StatesZurückgezogen» Google-Maps
East Carolina University / Vidant Health
27834 Greenville
United StatesRekrutierend» Google-Maps
Ohio State Comp. Cancer Ctr. / James Cancer Hospital
43210 Columbus
United StatesZurückgezogen» Google-Maps
Mercy Health Youngstown
44501 Youngstown
United StatesRekrutierend» Google-Maps
Children's Hospital of Philadelphia
19104 Philadelphia
United StatesRekrutierend» Google-Maps
University of Pennsylvania (Penn Med)
19104 Philadelphia
United StatesZurückgezogen» Google-Maps
Allegheny Health Network
15212 Pittsburgh
United StatesAbgebrochen» Google-Maps
Medical Univ. of South Carolina
29425 Charleston
United StatesRekrutierend» Google-Maps
St. Jude Children's Research Hospital
38105 Memphis
United StatesRekrutierend» Google-Maps
Vanderbilt University Medical Center
37232 Nashville
United StatesRekrutierend» Google-Maps
UT Southwestern Medical Center / Children's Health
75390 Dallas
United StatesRekrutierend» Google-Maps
MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
Intermountain Healthcare - Intermountain Medical Center
84107 Murray
United StatesZurückgezogen» Google-Maps
Intermountain Healthcare - Dixie Regional Medical Center
84790 Saint George
United StatesZurückgezogen» Google-Maps
Univ. of Utah / Huntsman Cancer Center
84112 Salt Lake City
United StatesRekrutierend» Google-Maps
West Virginia University
26506 Morgantown
United StatesRekrutierend» Google-Maps
Gundersen Health System
54601 La Crosse
United StatesRekrutierend» Google-Maps
SSM Health Cancer Center - Dean Medical Group
53717 Madison
United StatesRekrutierend» Google-Maps
Many Locations
Multiple Locations
AustraliaNoch nicht rekrutierend» Google-Maps
Many Locations
Multiple Locations
BrazilNoch nicht rekrutierend» Google-Maps
Many Locations
Multiple Locations
GreeceNoch nicht rekrutierend» Google-Maps
Many Locations
Multiple Locations
Korea, Republic ofRekrutierend» Google-Maps
Many Locations
Multiple Locations
Russian FederationZurückgezogen» Google-Maps
Many Locations
Multiple Locations
TaiwanNoch nicht rekrutierend» Google-Maps
Many Locations
Multiple Locations
United KingdomNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

In this observational study researcher want to learn more about the effectiveness of drug

VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use

in patients with TRK fusion cancer which is locally advanced or spread from the place where

it started to other places in the body. TRK fusion cancer is a term used to describe a

variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic

Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or

fuses, with a different gene. This joining results in the activation of certain proteins (TRK

fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an

approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult

and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the

decision to treat their disease with VITRAKVI has been made by their treating physicians.

During the study, patients' medical information such as treatment information with VITRAKVI,

other medication or treatments, changes in disease status and other health signs and symptoms

will be collected within the normal medical care by the treating doctor. Participants will be

observed over a period from 24 to 60 months.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Adult and pediatric (from 1 month to 18-year-old) patients

- Patients with locally advanced or metastatic solid tumor harboring an NTRK gene

fusion. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified locally.

Acceptable methods of detection of NTRK gene fusion include NGS, fluorescence in situ

hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any

other genomic testing able to detect NTRK gene fusion. If a pan-TRK IHC method is

used, this result needs to be accompanied with the results using one of the other

methods noted above.

- Life expectancy of at least 3 months based on clinical judgement

- Decision to treat with larotrectinib made by the treating physician prior to study

enrollment

- Patients can also be enrolled if the initial visit (larotrectinib start date) occurred

within 2 months ±3 days prior to informed consent signed date

- Signed informed consent form

- For patients under legal age, signed assent by the patient (where applicable) and

parental/legal guardian signed informed consent is required

Exclusion Criteria:

- Any contraindications as listed in the local approved product information

- Pregnancy

- Participation in an investigational program with interventions outside of routine

clinical practice

- Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition

- Patients with NTRK gene amplification or NTRK point mutation

Studien-Rationale

Primary outcome:

1. Number of participants with treatment-emergent adverse events (TEAEs) (Time Frame - Up to 30 days after last dose)

2. Severity of TEAEs (Time Frame - Up to 30 days after last dose)

3. Seriousness of TEAEs (Time Frame - Up to 30 days after last dose)

4. Outcome of TEAEs (Time Frame - Up to 30 days after last dose)

5. Causality of TEAEs (Time Frame - Up to 30 days after last dose)

6. Action taken related to larotrectinib treatment (Time Frame - Up to 30 days after last dose)

Secondary outcome:

1. Objective response rate (ORR) (Time Frame - Up to 8 years)

2. Disease control rate (DCR) (Time Frame - Up to 8 years)

3. Duration of response (DOR) (Time Frame - Up to 8 years)

4. Time to response (TTR) (Time Frame - Up to 8 years)

5. Progression-free survival (PFS) (Time Frame - Up to 8 years)

6. Overall survival (OS) (Time Frame - Up to 8 years)

7. Total dose (Time Frame - Up to 8 years)

8. Starting and ending dose (Time Frame - Up to 8 years)

9. Dose modification during treatment (Time Frame - Up to 8 years)

10. Duration of treatment (DOT) (Time Frame - Up to 8 years)

11. ORR by patient subgroup(s) (Time Frame - Up to 8 years)

12. DCR by patient subgroup(s) (Time Frame - Up to 8 years)

13. DOR by patient subgroup(s) (Time Frame - Up to 8 years)

14. TTR by patient subgroup(s) (Time Frame - Up to 8 years)

15. PFS by patient subgroup(s) (Time Frame - Up to 8 years)

16. OS by patient subgroup(s) (Time Frame - Up to 8 years)

17. Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal) (Time Frame - Up to 8 years):
for all patients

18. Number of patients with abnormal developmental milestones (Time Frame - Up to 8 years):
Pediatric cohort only

19. Number of patients with abnormal Tanner stage (Time Frame - Up to 8 years):
Pediatric cohort only

Studien-Arme

  • GI
    adult patients with gastrointestinal (GI) cancer
  • H&N
    adult patients with head and neck (H&N) cancer
  • STS
    adult patients with soft tissue sarcoma (STS)
  • CNS
    adult patients with primary central nervous system (CNS) cancer
  • Lung
    adult patients with lung cancer
  • Melanoma
    adult patients with melanoma
  • Pediatric
    all pediatric patients regardless of tumor type will be enrolled under this cohort
  • other
    patients with other tumor types

Geprüfte Regime

  • larotrectinib(Vitrakvi, BAY2757556):
    In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol

Quelle: ClinicalTrials.gov


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