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NCT02637687 · ClinicalTrials.gov registry record · Phase 1
A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children
A Phase 1 study of Solid Tumors Harboring NTRK Fusion, sponsored by Bayer.
- Active
- Registry status
- Phase 1
- Development phase
- 154
- Enrollment target
- 20
- Study locations
NCT02637687: Active Phase 1 study of Solid Tumors Harboring NTRK Fusion, sponsored by Bayer.
NCT02637687 is a Phase 1 study of Solid Tumors Harboring NTRK Fusion that is active but no longer recruiting, run by Bayer. The registered enrollment target is 154 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (157% higher). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02637687, a Phase 1 study of Solid Tumors Harboring NTRK Fusion, is active but no longer recruiting, sponsored by Bayer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 154 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
DLT: Dose-limiting toxicity. NCI-CTCAE: National Cancer Institute-Common Terminology Criteria for Adverse Events.
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 |
What the registry record for NCT02637687 still lists
NCT02637687 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (157% higher).
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.
NCT02637687 names 20 study sites across 18 states, led by California, Florida, Massachusetts.
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.
What interventions are being tested in trial NCT02637687?
The interventions under investigation include: Larotrectinib (Vitrakvi, BAY2757556) (DRUG).
Who is sponsoring clinical trial NCT02637687?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT02637687's enrollment target sits among peer trials
154 356th of 2000 higher than 1,643 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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