Study to allow access to dabrafenib and/or trametinib for subjects that are benefiting from dabrafenib and/or trametinib treatment in a Novartis or GSK sponsored study

An open label, multi-center roll-over study to assess longterm 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

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210131

Enrollment

Registered

2021-06-04

Start date

2021-07-05

Completion date

Unknown

Last updated

2026-05-25

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

Conditions

Rare Cancers

Interventions

Dabrafenib and/or trametinib are use based on the parent protocol. The starting dose should be the same dosage the subject was receiving at the completion of the parent study.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient is currently receiving treatment with dabrafenib/trametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective. In the opinion of the Investigator would benefit from continued treatment.

Exclusion criteria

Exclusion criteria: Patient has been previously permanently discontinued from study treatment in the parent protocol. Patient's indication is commercially available and reimbursed in the local country. Patient currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.

Design outcomes

Primary

Measure	Time frame
The primary objective is to evaluate long-term safety as assessed by occurrence of AEs/SAEs	—

Countries

Argentina, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Russia, Slovakia, Spain, Sweden, Thailand, Ukraine, United Kingdom, United States of America

Contacts

Public ContactKazuyuki Suzuki

Novartis Pharma. K.K.

rinshoshiken.toroku2@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: May 29, 2026