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NCT02684058 · ClinicalTrials.gov registry record · Phase 2

Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors

A Phase 2 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
151
Enrollment target

NCT02684058: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.

NCT02684058 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 151 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02684058, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
151 participants
Enrollment target

Study Summary

The purpose of this study was to investigate the activity of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive low grade glioma (LGG) or relapsed or refractory high grade glioma (HGG)

Primary Outcome

Percentage of participants in the LGG cohort with a best overall confirmed Complete Response (CR) or Partial Response (PR) as assessed per RANO criteria by central independent assessment. The 95% confidence intervals (CIs) were computed using two-sided exact binomial method. CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only o

Interventions

  • DRUG Carboplatin
  • DRUG Vincristine
  • DRUG trametinib
  • DRUG Dabrafenib

Trial Details

FieldValue
Enrollment Target 151 participants
Start Date 2017-12-28
Est. Completion 2023-04-28
Phase Phase 2
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT02684058 record still lists

NCT02684058 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher).

The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.

NCT02684058 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02684058 about?

NCT02684058 is a clinical study titled "Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors". The purpose of this study was to investigate the activity of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive low grade glioma (LGG) or relapsed or refractory high grade glioma (HGG)

What is the current status of trial NCT02684058?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 151 participants. The study started on 2017-12-28. Estimated completion is 2023-04-28.

What interventions are being tested in trial NCT02684058?

The interventions under investigation include: Carboplatin (DRUG), Vincristine (DRUG), trametinib (DRUG), Dabrafenib (DRUG).

Who is sponsoring clinical trial NCT02684058?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02684058's enrollment target sits among peer trials

151 454th of 2000 higher than 1,546 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT02684058, the US trial registry maintained by the National Library of Medicine. NCT02684058 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.