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An open label, multi-center roll-over study to assess longterm effect in pediatric patients treated with Tafinlar (dabrafenib) and/or Mekinist (trametinib)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509276-42-00
Acronym
CDRB436G2401
Enrollment
68
Registered
2024-07-19
Start date
2019-10-30
Completion date
Unknown
Last updated
2025-12-22

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

Conditions

Children and Adolescents with Cancers Harboring V600 mutation.

Brief summary

AEs, SAE, clinically significant changes in laboratory values and vital signs.

Detailed description

Serial measurements of height, weight, skeletal maturation, sexual maturation and cardiac function., Disease specific clinical benefit, as determined by investigator using institutional standard of care.

Interventions

Sponsors

Novartis Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
AEs, SAE, clinically significant changes in laboratory values and vital signs.

Secondary

MeasureTime frame
Serial measurements of height, weight, skeletal maturation, sexual maturation and cardiac function., Disease specific clinical benefit, as determined by investigator using institutional standard of care.

Countries

Belgium, Czechia, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, Sweden

Outcome results

None listed

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