An open label, multi-center roll-over study to assess long-term safety in patients who are ongoing or have completed a prior global Novartis or GSK sponsored Tafinlar (dabrafenib) and/or Mekinist (trametinib) study and are judged by the investigator to benefit from continued treatment.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509318-13-00

Acronym

CDRB436X2X02B

Enrollment

Registered

2024-08-01

Start date

2018-01-15

Completion date

Unknown

Last updated

2025-08-01

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

Conditions

Multiple indications

Brief summary

Frequency and severity of AEs/SAEs.

Detailed description

Proportion of subjects with clinical benefit as assessed by the Investigator at scheduled visits.

Interventions

DRUGTMT212

DRUGDRB436

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Frequency and severity of AEs/SAEs.	—

Secondary

Measure	Time frame
Proportion of subjects with clinical benefit as assessed by the Investigator at scheduled visits.	—

Countries

Austria, Denmark, France, Germany, Hungary, Netherlands, Spain

Outcome results

None listed

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