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Optimization of the Time and Dosage of Trametinib in BRAF Negative Juvenile Patients

NCT04943224 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-03-27

No results posted yet for this study

Summary

Prospective, interventional, open, randomized, single-center, non-commercial clinical trial to optimize treatment and dosage of trametinib in juvenile patients with histiocytosis resistant to conventional therapy and without the BRAF gene mutation or after the failure of vemurafenib treatment.

Conditions

  • Histiocytosis

Interventions

DRUG

Trametinib

\< 6 lat 0,032mg/kg, ≥ 6 lat 0,025mg/kg,

Sponsors & Collaborators

  • Maria Sklodowska-Curie National Research Institute of Oncology

    collaborator OTHER

  • Łukasiewicz Research Network

    collaborator UNKNOWN

  • Wrocław University of Environmental and Life Sciences

    collaborator UNKNOWN

  • Anna Raciborska

    lead OTHER

Principal Investigators

  • Anna Raciborska · Mother and Child Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04943224 on ClinicalTrials.gov