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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Assessed by National Cancer Institute Common Terminology for Adverse Events Criteria (NCI CTCAE v4.03)

Conditions Studied

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
Hoffmann-La Roche

909 total trials

What the registry record for NCT02650401 still lists

NCT02650401 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (76% lower).

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 names 20 study sites across 17 states, led by 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.

Similar trials for Solid Tumors

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02650401's enrollment target sits among peer trials

69 64th of 125 higher than 62 of 125 other Solid Tumors trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Solid Tumors 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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Source: ClinicalTrials.gov NCT02650401, the US trial registry maintained by the National Library of Medicine. NCT02650401 (small enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.