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Taking people in AustriaPhase 4

Continued access to dabrafenib and trametinib for patients from earlier studies

Gives continued dabrafenib or trametinib to adults whose earlier study has ended.

Key facts

Who runs it
Novartis Pharmaceuticals
Where
Innsbruck, AustriaSee the siteAlso in 14 other countries, 32 sites
Registry title
Dabrafenib and/or Trametinib Rollover Study
Status
Recruiting
Phase
Phase 4
People taking part
100 people, planned
Started
26 Jan 2018
Expected to end
28 Dec 2032
Type of study
Interventional, 3 groups
Treatments tested
  • dabrafenib
  • trametinib
Record updated
10 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people who are still taking dabrafenib and/or trametinib in a Novartis or former GSK trial and whose doctor thinks they would benefit from continuing.

Age
18 to 100 years
Sex
All sexes can join.
Earlier treatment
Must be taking dabrafenib and/or trametinib now, as a single drug or together, in a Novartis or former GSK trial that met its main goal. Must not have been permanently taken off treatment in that trial.

Main reasons for not taking part

  • Was permanently taken off treatment in the earlier trial
  • The condition can be treated with a commercially available, reimbursed medicine in the local country
  • Has unresolved side effects that stopped dabrafenib and/or trametinib dosing in the earlier trial

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 100 years old?

Where in Austria

Also in 14 other countries, 32 sites

  • Medizinische Universitaet InnsbruckInnsbruck, AustriaTaking people

About the trial

What the trial wants to find out

This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.

The 3 groups in the trial

  • dabrafenib monotherapyTreatment being tested

    Patients in this study may receive: \- monotherapy of dabrafenib

    Treatment: dabrafenib

  • trametinib monotherapyTreatment being tested

    Patients in this study may receive: \- monotherapy of trametinib

    Treatment: trametinib

  • Combination therapy (dabrafenib & trametinib)Treatment being tested

    Patients in this study may receive: \- the combination of dabrafenib and trametinib

    Treatment: dabrafenib and trametinib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and/or Trametinib Study
Plain-language title
Continued access to dabrafenib and trametinib for patients from earlier studiesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT03340506, who can take part
Record updated
10 November 2026