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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)

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ClinicalTrials.gov Identifier: NCT04142437
Recruitment Status : Recruiting
First Posted : October 29, 2019
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment
Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion Drug: larotrectinib(Vitrakvi, BAY2757556)

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib
Actual Study Start Date : April 3, 2020
Estimated Primary Completion Date : November 30, 2027
Estimated Study Completion Date : March 31, 2028

Group/Cohort Intervention/treatment
GI
adult patients with gastrointestinal (GI) cancer
Drug: 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

H&N
adult patients with head and neck (H&N) cancer
Drug: 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

STS
adult patients with soft tissue sarcoma (STS)
Drug: 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

CNS
adult patients with primary central nervous system (CNS) cancer
Drug: 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

Lung
adult patients with lung cancer
Drug: 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

Melanoma
adult patients with melanoma
Drug: 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

Pediatric
all pediatric patients regardless of tumor type will be enrolled under this cohort
Drug: 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

other
patients with other tumor types
Drug: 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




Primary Outcome Measures :
  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 Measures :
  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 abnormal neurological assessments [ Time Frame: Up to 8 years ]
  18. Change in height and weight from baseline by visit [ Time Frame: Up to 8 years ]
    Pediatric cohort only

  19. Number of patients with abnormal developmental milestones [ Time Frame: Up to 8 years ]
    Pediatric cohort only

  20. Number of patients with abnormal Tanner stage [ Time Frame: Up to 8 years ]
    Pediatric cohort only



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult and pediatric (from birth to 18 year old) patients with a locally advanced or metastatic solid tumor harboring an NTRK gene fusion (detected by NGS (Next-Generation Sequencing), FISH (Fluorescent In Situ Hybridization), rt-PCR (Reverse Transcription Polymerase Chain Reaction) or other genomic testing able to detect NTRK gene fusion) assessed locally for whom a decision to treat with larotrectinib has been made by the treating physician prior to or at the time of study enrollment
Criteria

Inclusion Criteria:

  • Adult and pediatric (from birth 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04142437


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04142437    
Other Study ID Numbers: 20324
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No