NCT04142437|RecruitingFDA Drug

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

ON-TRK

PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib

Bayer ClinicalTrials.gov

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1 other identifier

20324

Study Type

observational

Target

150

Locations

25 countries

Sites

Timeline

RegisteredOct 2019

StartedApr 2020

CompletionMar 2030

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

150

participants targeted

Target at P50-P75 for all trials

Timeline

48mo left

Started Apr 2020

Longer than P75 for all trials

Geographic Reach

25 countries

75 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

10 years study duration

Study Progress61%

Apr 2020Mar 2030

First Submitted

Initial submission to the registry

October 17, 2019

Completed

12 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed

5 months until next milestone

Study Start

First participant enrolled

April 3, 2020

Completed

9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2029

Expected

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2030

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

9.7 years

First QC Date

October 17, 2019

Last Update Submit

April 13, 2026

Conditions

Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Outcome Measures

Primary Outcomes (6)

Number of participants with treatment-emergent adverse events (TEAEs)
Up to 30 days after last dose
Severity of TEAEs
Up to 30 days after last dose
Seriousness of TEAEs
Up to 30 days after last dose
Reasonable causal relationship between larotrectinib and an AE
Up to 30 days after last dose
Causality of TEAEs
Up to 30 days after last dose
Action taken related to larotrectinib treatment
Up to 30 days after last dose

Secondary Outcomes (19)

Objective response rate (ORR)
Up to 8 years
Disease control rate (DCR)
Up to 8 years
Duration of response (DOR)
Up to 8 years
Time to response (TTR)
Up to 8 years
Progression-free survival (PFS)
Up to 8 years
+14 more secondary outcomes