CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Binimetinibdrug
Likely dose
Binimetinib 45mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03231306
NCT03231306Phase 2Completed
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A Phase II Study of Binimetinib in Children and Adults With NF1 Associated Plexiform Neurofibromas (PNOC010)

University of Alabama at Birmingham·interventional·Posted Jul 27, 2017·Updated May 2, 2025

In Brief

A Phase 2 clinical trial evaluating Binimetinib for Neurofibromatosis Type 1 and Plexiform Neurofibroma. Completed, enrolled 45 participants across 22 sites.

Detailed Summary

This is a phase II open label study that will evaluate children ≥ 1 year of age and adults with neurofibromatosis type 1 (NF1) and plexiform neurofibromas treated with the MEK inhibitor, binimetinib. The primary objective is to determine if there is an adequate level of disease responsiveness to binimetinib in children and adults with NF1 and inoperable plexiform neurofibromas. The objective response to binimetinib is defined as ≥ 20% decrease in tumor volume reduction by 12 courses.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeurofibromatosis Type 1, Plexiform Neurofibroma
CountriesUnited States
CollaboratorsArray BioPharma, Pacific Pediatric Neuro-Oncology Consortium

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 27, 2017
Enrollment StartNov 28, 2017
Primary CompletionApr 17, 2024
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 8.9 years ago

Interventions

Binimetinibdrug

Adult subjects (18 years and older) will receive binimetinib by mouth twice daily of 45mg/dose. Pediatric subjects (1-17 years of age) are being treated on the pediatric MTD established by a phase I study (NCT02285439).