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NCT02650401 · ClinicalTrials.gov registry record · Phase 1

Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options

A Phase 1 study of Solid Tumors and CNS Tumors, sponsored by Hoffmann-La Roche.

Active
Registry status
Phase 1
Development phase
69
Enrollment target
20
Study locations

NCT02650401 is a Phase 1 study of Solid Tumors and CNS Tumors that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 69 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT02650401, a Phase 1 study of Solid Tumors and CNS Tumors, is active but no longer recruiting, sponsored by Hoffmann-La Roche.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
69 participants
Enrollment target
20
Study locations

Study Summary

This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain tumors harboring NTRK1/2/3 or ROS1 gene fusions, and extracranial solid tumors harboring NTRK1/2/3 or ROS1 gene fusions.

Conditions Studied

Solid Tumors CNS Tumors

Interventions

  • DRUG Entrectinib

Study Locations (20)

Other

  • Beijing Children's Hospital, Capital Medical University - Beijing
  • Centre Leon Berard - Lyon
  • Hôpital de la Timone, Oncologie Pédiatrique - Marseille

California

  • University of California San Diego - La Jolla
  • UCSF Benioff Children's Hospital - San Francisco

Colorado

  • Children's Hospital Colorado - Aurora

Georgia

  • Egleston Children's Hospital at Emory University Atlanta - Atlanta

Illinois

  • University of Chicago - Chicago

Maryland

  • Johns Hopkins University - Baltimore

Massachusetts

  • Dana Farber Cancer Institute - Boston

Missouri

  • Washington University,St. Louis Children's Hospital - St Louis

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2016-05-03
Est. Completion 2026-06-30
Phase Phase 1

Sponsor

Hoffmann-La Roche

909 total trials

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What the Registry Record Tells You About NCT02650401

The ClinicalTrials.gov registry entry for NCT02650401 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (76% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which Entrectinib is the first listed.

NCT02650401 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Other, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT02650401 about?

NCT02650401 is a clinical study titled "Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options". This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain tumors harboring NTRK1/2/3 or ROS1 gene fusions, and extracranial solid...

What is the current status of trial NCT02650401?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2016-05-03. Estimated completion is 2026-06-30.

What conditions does trial NCT02650401 study?

This clinical trial studies the following conditions: Solid Tumors, CNS Tumors.

What interventions are being tested in trial NCT02650401?

The interventions under investigation include: Entrectinib (DRUG).

Who is sponsoring clinical trial NCT02650401?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02650401 being conducted?

This trial has 20 study locations across California, Colorado, Georgia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.