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NCT04142437 · ClinicalTrials.gov registry record
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
A clinical trial of Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion, sponsored by Bayer.
- Recruiting
- Registry status
- 150
- Enrollment target
- 20
- Study locations
NCT04142437: Recruiting study of Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion, sponsored by Bayer.
NCT04142437 is a study of Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion that is actively recruiting participants, run by Bayer. The registered enrollment target is 150 participants. The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04142437, a study of Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion, is actively recruiting participants, sponsored by Bayer.
- RECRUITING
- Registry status
- 150 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG larotrectinib(Vitrakvi, BAY2757556)
Study Locations (20)
California
- California Research Inst. - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- UCLA - Mattel Children's Hospital - Los Angeles
- Hoag Memorial Hospital Presbyterian - Newport Beach
- UCSF Benioff Children's Hospital Oakland - Oakland
- Stanford Univ Med Ctr. / Lucile Packard Children's Hosp - Palo Alto
- Providence Health System - Southern California - Santa Monica
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance
Florida
- Mayo Clinic - Jacksonville
- University of Miami - Miami
- Nicklaus Children's Hospital - Miami
- Nemours Children's Hospital - Orlando
Indiana
- Fort Wayne Medical Oncology Hematology - Fort Wayne
- Regional Health Hope Center - Terre Haute
Arizona
- Banner Desert Medical Center - Mesa
Colorado
- SCL Health - Grand Junction
Connecticut
- Yale University - New Haven
Kansas
- Cancer Center of Kansas - Wichita
Maine
- Maine Health - South Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2020-04-03 |
| Est. Completion | 2030-03-31 |
What NCT04142437 shows while recruiting
NCT04142437 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion appearing as the primary indexed condition, and to 1 intervention - of which larotrectinib(Vitrakvi, BAY2757556) is the first listed.
NCT04142437 names 20 study sites across 9 states, led by California, Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT04142437 about?
NCT04142437 is a clinical study titled "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". 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 place...
What is the current status of trial NCT04142437?
This trial is currently recruiting. The enrollment target is 150 participants. The study started on 2020-04-03. Estimated completion is 2030-03-31.
What conditions does trial NCT04142437 study?
This clinical trial studies the following conditions: Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion.
What interventions are being tested in trial NCT04142437?
The interventions under investigation include: larotrectinib(Vitrakvi, BAY2757556) (DRUG).
Who is sponsoring clinical trial NCT04142437?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04142437 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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