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A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children
NCT02637687 · View on ClinicalTrials.gov ↗
Study Summary
The study is being done to test the safety of a cancer drug called larotrectinib in children. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. The first study part (Phase 1) is done to determine what dose level of larotrectinib is safe for children, how the drug is absorbed and changed by their bodies and how well the cancer responds to the drug. The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with larotrectininb.
Conditions Studied
Interventions
- DRUG Larotrectinib (Vitrakvi, BAY2757556)
Study Locations (20)
California
- Children's Hospital Los Angeles - Hematology/Oncology — Los Angeles
- UCLA Jonsson Comprehensive Cancer Center — Los Angeles
- Lucille Packard Children's Hospital Stanford - Pediatric Nephrology — Palo Alto
Florida
- Nemours Children's Hospital - Florida - Hematology / Oncology — Orlando
Massachusetts
- Dana-Farber Cancer Institute — Boston
New York
- Memorial Sloan Kettering Cancer Center New York - Main Campus — New York
Ohio
- Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension — Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia - Hematology/Oncology — Philadelphia
Tennessee
- St. Jude Children's Research Hospital — Memphis
Texas
- University of Texas Southwestern Medical Center — Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2015-12-16 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02637687
The ClinicalTrials.gov registry entry for NCT02637687 describes a study currently listed as active not recruiting. It is categorized as Phase 1, 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 154 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 Solid Tumors Harboring NTRK 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: NCT02637687 reports 20 study locations spanning 18 distinct geographic areas — top geographies include California, Florida, Massachusetts. 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 NCT02637687 about?
NCT02637687 is a clinical study titled "A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children". The study is being done to test the safety of a cancer drug called larotrectinib in children. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. The first study p...
What is the current status of trial NCT02637687?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 154 participants. The study started on 2015-12-16. Estimated completion is 2026-09-30.
What conditions does trial NCT02637687 study?
This clinical trial studies the following conditions: Solid Tumors Harboring NTRK 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 NCT02637687?
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 NCT02637687?
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 NCT02637687 being conducted?
This trial has 20 study locations across California, Florida, Massachusetts, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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