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NCT03962543 · ClinicalTrials.gov registry record · Phase 2

MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas

A Phase 2 study of Plexiform Neurofibroma and Neurofibromatosis Type 1 (NF1), sponsored by SpringWorks Therapeutics.

Active
Registry status
Phase 2
Development phase
114
Enrollment target
20
Study locations

NCT03962543 is a Phase 2 study of Plexiform Neurofibroma and Neurofibromatosis Type 1 (NF1) that is active but no longer recruiting, run by SpringWorks Therapeutics. The registered enrollment target is 114 participants, below the 240-participant average among 7 other Plexiform Neurofibroma trials with a reported enrollment target (52% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT03962543, a Phase 2 study of Plexiform Neurofibroma and Neurofibromatosis Type 1 (NF1), is active but no longer recruiting, sponsored by SpringWorks Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
114 participants
Enrollment target
20
Study locations

Study Summary

This study evaluates mirdametinib (PD-0325901) in the treatment of symptomatic inoperable neurofibromatosis type-1 (NF1)-associated plexiform neurofibromas (PNs). All participants will receive mirdametinib (PD-0325901). Eligible participants may continue in a long-term follow-up phase.

Conditions Studied

Plexiform Neurofibroma Neurofibromatosis Type 1 (NF1)

Interventions

  • DRUG Mirdametinib (PD-0325901) oral capsule or dispersible tablet

Study Locations (20)

California

  • Children's Hospital Los Angeles - Los Angeles
  • UCLA Oncology Center - Los Angeles
  • University of California - Irvine Health - Orange
  • Children's Hospital of Orange County - Orange
  • Lucile Packard Children's Hospital Stanford - Palo Alto
  • University of California - Davis Comprehensive Cancer Center - Sacramento

Florida

  • University of Florida Clinical Research Center - Gainesville
  • Nicklaus Children's Hospital - Miami
  • AdventHealth Pediatric Oncology Hematology at Orlando - Orlando
  • Orlando Health, Inc. - Orlando
  • Johns Hopkins All Children's Hospital - St. Petersburg
  • Moffitt Cancer Center - Tampa

Alabama

  • University of Alabama at Birmingham/Children's of Alabama - Birmingham

Arizona

  • Mayo Clinic Hospital - Phoenix

Arkansas

  • Arkansas Children's Hospital - Little Rock

Colorado

  • Children's Hospital Colorado - Aurora

Delaware

  • Nemours A. I. duPont Hospital for Children - Wilmington

District of Columbia

  • Children's National Medical Center - Washington D.C.

Trial Details

FieldValue
Enrollment Target 114 participants
Start Date 2019-09-29
Est. Completion 2028-12-22
Phase Phase 2

Sponsor

SpringWorks Therapeutics

7 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03962543

The ClinicalTrials.gov registry entry for NCT03962543 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 240-participant average among 7 other Plexiform Neurofibroma trials with a reported enrollment target (52% lower). The listed sponsor is SpringWorks Therapeutics, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Plexiform Neurofibroma appearing as the primary indexed condition, and to 1 intervention - of which Mirdametinib (PD-0325901) oral capsule or dispersible tablet is the first listed.

NCT03962543 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Alabama.

Frequently Asked Questions

What is clinical trial NCT03962543 about?

NCT03962543 is a clinical study titled "MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas". This study evaluates mirdametinib (PD-0325901) in the treatment of symptomatic inoperable neurofibromatosis type-1 (NF1)-associated plexiform neurofibromas (PNs). All participants will receive mirdametinib (PD-0325901). Eligible participants may continue in a long-term follow-up phase.

What is the current status of trial NCT03962543?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2019-09-29. Estimated completion is 2028-12-22.

What conditions does trial NCT03962543 study?

This clinical trial studies the following conditions: Plexiform Neurofibroma, Neurofibromatosis Type 1 (NF1).

What interventions are being tested in trial NCT03962543?

The interventions under investigation include: Mirdametinib (PD-0325901) oral capsule or dispersible tablet (DRUG).

Who is sponsoring clinical trial NCT03962543?

This trial is sponsored by SpringWorks Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03962543 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. 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.