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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 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. The trial reports 20 study locations across 18 states.

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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.

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

FieldValue
Enrollment Target 154 participants
Start Date 2015-12-16
Est. Completion 2026-09-30
Phase Phase 1

Sponsor

Bayer

591 total trials

What the Registry Record Tells You About NCT02637687

The ClinicalTrials.gov registry entry for NCT02637687 describes a study currently listed as active not recruiting, categorized as Phase 1. 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 591 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 18 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.