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NCT01748149 · ClinicalTrials.gov registry record · Early Phase 1

Vemurafenib in Children With Recurrent/Refractory BRAF Gene V600E (BRAFV600E)-Mutant Gliomas

A Early Phase 1 study, sponsored by University of California, San Francisco.

Completed
Registry status
Early Phase 1
Development phase
40
Enrollment target

NCT01748149: Completed Early Phase 1 study, sponsored by University of California, San Francisco.

NCT01748149 is a Early Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 40 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01748149, a Early Phase 1 study, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Early Phase 1
Development phase
40 participants
Enrollment target

Study Summary

This is a multicenter, safety and pharmacokinetic trial to determine the MTD and/or select a recommended phase 2 dose (RP2D) of vemurafenib in children with recurrent or refractory gliomas containing the BRAFV600E or BRAF Ins T mutation.

Primary Outcome

To determine if the maximum tolerated dose of vemurafenib established in adults is safe and tolerable in pediatric patients with BRAFV600E-mutant gliomas. (Dose is adjusted for pediatric use. Weighted dose extrapolated from FDA approved standard adult dose)

Interventions

  • DRUG Vemurafenib

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2014-04-29
Est. Completion 2025-07-31
Phase Early Phase 1

What the finished NCT01748149 record still lists

NCT01748149 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (25% lower).

The record links to 0 conditions, and to 1 intervention - of which Vemurafenib is the first listed.

NCT01748149 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01748149 about?

NCT01748149 is a clinical study titled "Vemurafenib in Children With Recurrent/Refractory BRAF Gene V600E (BRAFV600E)-Mutant Gliomas". This is a multicenter, safety and pharmacokinetic trial to determine the MTD and/or select a recommended phase 2 dose (RP2D) of vemurafenib in children with recurrent or refractory gliomas containing the BRAFV600E or BRAF Ins T mutation.

What is the current status of trial NCT01748149?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2014-04-29. Estimated completion is 2025-07-31.

What interventions are being tested in trial NCT01748149?

The interventions under investigation include: Vemurafenib (DRUG).

Who is sponsoring clinical trial NCT01748149?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01748149's enrollment target sits among peer trials

40 629th of 2000 higher than 1,312 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early 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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Source: ClinicalTrials.gov NCT01748149, the US trial registry maintained by the National Library of Medicine. NCT01748149 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.