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RECRUITING

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

NCT04142437 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 150 participants
Start Date 2020-04-03
Est. Completion 2030-03-31

Sponsor

Bayer

143 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04142437

The ClinicalTrials.gov registry entry for NCT04142437 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04142437 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04142437?

The interventions under investigation include: larotrectinib(Vitrakvi, BAY2757556) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04142437?

This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial