Optimalization Of The Time And Dosage Of Trametinib In BRAF Negative Juvenile Patients With Refractory Histiocytosis Or After Failure Of Vemurafenib Treatment.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515896-37-00

Acronym

TRAM

Enrollment

Registered

2024-08-26

Start date

2021-04-20

Completion date

Unknown

Last updated

2025-10-30

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

Conditions

histiocytic cell proliferation

Brief summary

EFS – (event-free survival)., Assessment of the safety of trametinib treatment by AE analysis including adverse events of a special interest., Assessment of the safety of trametinib treatment by vital signs, laboratory tests, echocardiography and ECG findings analysis., To determine dose of the investigated substance in patient below 18 y.o. that provides exposition to the drug similar to exposition recommended in adults.

Detailed description

PFS (Progression-Free Survival), OS (Overall Survival), ORR (Overall Response Rate), Reactivation rate after 2 years

Interventions

DRUGTRAMETINIB DIMETHYL SULFOXIDE

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
EFS – (event-free survival)., Assessment of the safety of trametinib treatment by AE analysis including adverse events of a special interest., Assessment of the safety of trametinib treatment by vital signs, laboratory tests, echocardiography and ECG findings analysis., To determine dose of the investigated substance in patient below 18 y.o. that provides exposition to the drug similar to exposition recommended in adults.	—

Measure

Time frame

—

Secondary

Measure	Time frame
PFS (Progression-Free Survival), OS (Overall Survival), ORR (Overall Response Rate), Reactivation rate after 2 years	—

Countries

Poland

Outcome results

None listed

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