NCT03340506RecruitingPhase 4
Dabrafenib and/or Trametinib Rollover Study
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 8 Nov 2017
- Start date
- 26 Jan 2018
- Primary completion date
- 28 Dec 2032
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Melanoma, Lung cancer, Childhood cancers
- NCT number
- NCT03340506
- EU CT number
- 2023-509318-13-00
- EudraCT number
- 2017-001987-39
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From 26 Jan 2018 to the primary completion date, 28 Dec 2032
- 33 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient has been previously permanently discontinued from study treatment in the parent protocol.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (33)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Investigative Site Coordinator of this site? Confirm its status | CABA | Argentina | Completed |
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Beijing | China | Completed |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Active, not recruiting |
| Fakultni Nemocnice Motol a Homolka Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Universitaetsklinikum Augsburg Coordinator of this site? Confirm its status | Augsburg | Germany | Active, not recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Active, not recruiting |
| Universitaetsklinikum Mannheim GmbH Coordinator of this site? Confirm its status | Mannheim | Germany | Active, not recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Infantil Universitario Nino Jesus Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Active, not recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Active, not recruiting |
| Orszagos Onkologiai Intezet Coordinator of this site? Confirm its status | Budapest XII | Hungary | Completed |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Completed |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Chuo Ku | Japan | Completed |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Kashiwa | Japan | Completed |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Songkhla | Thailand | Active, not recruiting |
| National Institute Of Health Coordinator of this site? Confirm its status | Bethesda | United States | Active, not recruiting |
| James Cancer Hospital and Solove Research Institute Ohio State Coordinator of this site? Confirm its status | Columbus | United States | Completed |
| Mary Crowley Cancer Research Coordinator of this site? Confirm its status | Dallas | United States | Completed |
| Honor Health Research Institute Coordinator of this site? Confirm its status | Scottsdale | United States | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.