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Trametinib in neurofibromatosis type 1 related symptomatic plexiform neurofibromas

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516593-30-00
Acronym
NL69517.078.19
Enrollment
30
Registered
2024-09-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurofibromatosis type 1

Brief summary

Tumor volume on volumetric MRI analysis

Detailed description

Numeric pain rating scale (NRS-11), Pain interference (PROMIS), QLQ-SF36, Medical photography, Adverse events according to CTCAEv5.0, Time to first significant progression defined as >20% volumetric growth of the index lesion(s), Incidence of surgical interventions

Interventions

DRUGMekinist 0.5 mg film-coated tablets

Sponsors

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Tumor volume on volumetric MRI analysis—

Secondary

MeasureTime frame
Numeric pain rating scale (NRS-11), Pain interference (PROMIS), QLQ-SF36, Medical photography, Adverse events according to CTCAEv5.0, Time to first significant progression defined as >20% volumetric growth of the index lesion(s), Incidence of surgical interventions—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026