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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
Scientific title
PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib
Secondary ID [1] 0 0
20324
Universal Trial Number (UTN)
Trial acronym
ON-TRK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
Up to 30 days after last dose
Primary outcome [2] 0 0
Severity of TEAEs
Timepoint [2] 0 0
Up to 30 days after last dose
Primary outcome [3] 0 0
Seriousness of TEAEs
Timepoint [3] 0 0
Up to 30 days after last dose
Primary outcome [4] 0 0
Outcome of TEAEs
Timepoint [4] 0 0
Up to 30 days after last dose
Primary outcome [5] 0 0
Causality of TEAEs
Timepoint [5] 0 0
Up to 30 days after last dose
Primary outcome [6] 0 0
Action taken related to larotrectinib treatment
Timepoint [6] 0 0
Up to 30 days after last dose
Secondary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
Up to 8 years
Secondary outcome [2] 0 0
Disease control rate (DCR)
Timepoint [2] 0 0
Up to 8 years
Secondary outcome [3] 0 0
Duration of response (DOR)
Timepoint [3] 0 0
Up to 8 years
Secondary outcome [4] 0 0
Time to response (TTR)
Timepoint [4] 0 0
Up to 8 years
Secondary outcome [5] 0 0
Progression-free survival (PFS)
Timepoint [5] 0 0
Up to 8 years
Secondary outcome [6] 0 0
Overall survival (OS)
Timepoint [6] 0 0
Up to 8 years
Secondary outcome [7] 0 0
Total dose
Timepoint [7] 0 0
Up to 8 years
Secondary outcome [8] 0 0
Starting and ending dose
Timepoint [8] 0 0
Up to 8 years
Secondary outcome [9] 0 0
Dose modification during treatment
Timepoint [9] 0 0
Up to 8 years
Secondary outcome [10] 0 0
Duration of treatment (DOT)
Timepoint [10] 0 0
Up to 8 years
Secondary outcome [11] 0 0
ORR by patient subgroup(s)
Timepoint [11] 0 0
Up to 8 years
Secondary outcome [12] 0 0
DCR by patient subgroup(s)
Timepoint [12] 0 0
Up to 8 years
Secondary outcome [13] 0 0
DOR by patient subgroup(s)
Timepoint [13] 0 0
Up to 8 years
Secondary outcome [14] 0 0
TTR by patient subgroup(s)
Timepoint [14] 0 0
Up to 8 years
Secondary outcome [15] 0 0
PFS by patient subgroup(s)
Timepoint [15] 0 0
Up to 8 years
Secondary outcome [16] 0 0
OS by patient subgroup(s)
Timepoint [16] 0 0
Up to 8 years
Secondary outcome [17] 0 0
Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)
Timepoint [17] 0 0
Up to 8 years
Secondary outcome [18] 0 0
Number of patients with abnormal developmental milestones
Timepoint [18] 0 0
Up to 8 years
Secondary outcome [19] 0 0
Number of patients with abnormal Tanner stage
Timepoint [19] 0 0
Up to 8 years

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
Minimum age
1 Month
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/04/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2030
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Many Locations - Multiple Locations
Recruitment postcode(s) [1] 0 0
- Multiple Locations
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Maine
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
State/province [23] 0 0
West Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Argentina
State/province [25] 0 0
Multiple Locations
Country [26] 0 0
Austria
State/province [26] 0 0
Multiple Locations
Country [27] 0 0
Belgium
State/province [27] 0 0
Multiple Locations
Country [28] 0 0
Brazil
State/province [28] 0 0
Multiple Locations
Country [29] 0 0
Canada
State/province [29] 0 0
Multiple Locations
Country [30] 0 0
China
State/province [30] 0 0
Multiple Locations
Country [31] 0 0
Denmark
State/province [31] 0 0
Multiple Locations
Country [32] 0 0
Finland
State/province [32] 0 0
Multiple Locations
Country [33] 0 0
France
State/province [33] 0 0
Multiple Locations
Country [34] 0 0
Germany
State/province [34] 0 0
Multiple Locations
Country [35] 0 0
Greece
State/province [35] 0 0
Multiple Locations
Country [36] 0 0
Ireland
State/province [36] 0 0
Multiple Locations
Country [37] 0 0
Italy
State/province [37] 0 0
Multiple Locations
Country [38] 0 0
Japan
State/province [38] 0 0
Multiple Locations
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Multiple Locations
Country [40] 0 0
Luxembourg
State/province [40] 0 0
Multiple Locations
Country [41] 0 0
Norway
State/province [41] 0 0
Multiple Locations
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Multiple Locations
Country [43] 0 0
Singapore
State/province [43] 0 0
Multiple Locations
Country [44] 0 0
Spain
State/province [44] 0 0
Multiple Locations
Country [45] 0 0
Sweden
State/province [45] 0 0
Multiple Locations
Country [46] 0 0
Switzerland
State/province [46] 0 0
Multiple Locations
Country [47] 0 0
Taiwan
State/province [47] 0 0
Multiple Locations
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Multiple Locations

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bayer Clinical Trials Contact
Address 0 0
Country 0 0
Phone 0 0
(+)1-888-84 22937
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.


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