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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04142437
Registration number
NCT04142437
Ethics application status
Date submitted
17/10/2019
Date registered
29/10/2019
Titles & IDs
Public title
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
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Scientific title
PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib
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Secondary ID [1]
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20324
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Universal Trial Number (UTN)
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Trial acronym
ON-TRK
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - larotrectinib(Vitrakvi, BAY2757556)
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
Treatment: Drugs: 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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with treatment-emergent adverse events (TEAEs)
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Assessment method [1]
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Timepoint [1]
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Up to 30 days after last dose
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Primary outcome [2]
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Severity of TEAEs
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Assessment method [2]
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Timepoint [2]
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Up to 30 days after last dose
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Primary outcome [3]
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Seriousness of TEAEs
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Assessment method [3]
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Timepoint [3]
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Up to 30 days after last dose
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Primary outcome [4]
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Outcome of TEAEs
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Assessment method [4]
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Timepoint [4]
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Up to 30 days after last dose
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Primary outcome [5]
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Causality of TEAEs
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Assessment method [5]
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Timepoint [5]
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Up to 30 days after last dose
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Primary outcome [6]
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Action taken related to larotrectinib treatment
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Assessment method [6]
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Timepoint [6]
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Up to 30 days after last dose
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Secondary outcome [1]
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Objective response rate (ORR)
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Assessment method [1]
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Timepoint [1]
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Up to 8 years
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Secondary outcome [2]
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Disease control rate (DCR)
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Assessment method [2]
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Timepoint [2]
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Up to 8 years
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Secondary outcome [3]
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Duration of response (DOR)
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Assessment method [3]
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Timepoint [3]
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Up to 8 years
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Secondary outcome [4]
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Time to response (TTR)
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Assessment method [4]
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Timepoint [4]
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Up to 8 years
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Secondary outcome [5]
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Progression-free survival (PFS)
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Assessment method [5]
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Timepoint [5]
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Up to 8 years
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Secondary outcome [6]
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Overall survival (OS)
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Assessment method [6]
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Timepoint [6]
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Up to 8 years
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Secondary outcome [7]
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Total dose
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Timepoint [7]
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Up to 8 years
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Secondary outcome [8]
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Starting and ending dose
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Timepoint [8]
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Up to 8 years
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Secondary outcome [9]
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Dose modification during treatment
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Assessment method [9]
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Timepoint [9]
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Up to 8 years
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Secondary outcome [10]
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Duration of treatment (DOT)
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Assessment method [10]
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Timepoint [10]
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Up to 8 years
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Secondary outcome [11]
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ORR by patient subgroup(s)
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Assessment method [11]
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Timepoint [11]
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Up to 8 years
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Secondary outcome [12]
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DCR by patient subgroup(s)
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Assessment method [12]
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Timepoint [12]
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Up to 8 years
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Secondary outcome [13]
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DOR by patient subgroup(s)
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Assessment method [13]
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Timepoint [13]
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Up to 8 years
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Secondary outcome [14]
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TTR by patient subgroup(s)
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Assessment method [14]
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Timepoint [14]
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Up to 8 years
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Secondary outcome [15]
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PFS by patient subgroup(s)
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Assessment method [15]
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Timepoint [15]
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Up to 8 years
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Secondary outcome [16]
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OS by patient subgroup(s)
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Assessment method [16]
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Timepoint [16]
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Up to 8 years
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Secondary outcome [17]
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Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)
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Assessment method [17]
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for all patients
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Timepoint [17]
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Up to 8 years
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Secondary outcome [18]
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Number of patients with abnormal developmental milestones
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Assessment method [18]
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Pediatric cohort only
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Timepoint [18]
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Up to 8 years
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Secondary outcome [19]
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Number of patients with abnormal Tanner stage
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Assessment method [19]
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Pediatric cohort only
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Timepoint [19]
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Up to 8 years
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Eligibility
Key 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
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Minimum age
1
Month
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/04/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/03/2030
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Many Locations - Multiple Locations
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Recruitment postcode(s) [1]
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- Multiple Locations
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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Florida
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United States of America
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Indiana
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Kansas
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Maine
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Michigan
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Nevada
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New Jersey
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New York
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North Carolina
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Argentina
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Austria
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United Kingdom
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bayer
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04142437
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Trial related presentations / publications
Yang JCH, Brose MS, Castro G, Kim ES, Lassen UN, Leyvraz S, Pappo A, Lopez-Rios F, Reeves JA, Fellous M, Penault-Llorca F, Rudzinski ER, Tabatabai G, Vassal G, Drilon A, Trent J. Rationale and design of ON-TRK: a novel prospective non-interventional study in patients with TRK fusion cancer treated with larotrectinib. BMC Cancer. 2022 Jun 7;22(1):625. doi: 10.1186/s12885-022-09687-x.
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Bayer Clinical Trials Contact
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Address
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Phone
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(+)1-888-84 22937
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04142437