Continued access to dabrafenib and trametinib for patients from earlier studies
Gives continued dabrafenib or trametinib to adults whose earlier study has ended.
Plain-language title generated from the registry record
Registry title: Dabrafenib and/or Trametinib Rollover Study
Key facts
- Where
- Barcelona, Madrid, and Valencia, SpainSee the 6 sites
- Phase
- Phase 4
Could this be for you?
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?
Source: NCT03340506, who can take part
Where in Spain
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital General Universitario Gregorio MarañónMadrid, SpainTaking people
- Hospital Infantil Universitario Nino JesusMadrid, SpainTaking people
- Hospital Universitario Fundación Jiménez DíazMadrid, SpainTaking people
- Hospital Universitario HM SanchinarroMadrid, SpainTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT03340506EU 2023-509318-13-00
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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.