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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
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

Full criteria on ClinicalTrials.gov

Sites (33)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Novartis Investigative Site
Coordinator of this site? Confirm its status
CABAArgentinaCompleted
Medizinische Universitaet Innsbruck
Coordinator of this site? Confirm its status
InnsbruckAustriaRecruiting
Novartis Investigative Site
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
Novartis Investigative Site
Coordinator of this site? Confirm its status
BeijingChinaCompleted
Fakultni nemocnice Brno
Coordinator of this site? Confirm its status
BrnoCzechiaActive, not recruiting
Fakultni Nemocnice Motol a Homolka
Coordinator of this site? Confirm its status
PragueCzechiaActive, not recruiting
Universitaetsklinikum Augsburg
Coordinator of this site? Confirm its status
AugsburgGermanyActive, not recruiting
Universitaetsklinikum Essen (AoR)
Coordinator of this site? Confirm its status
EssenGermanyActive, not recruiting
University Medical Center Hamburg-Eppendorf
Coordinator of this site? Confirm its status
HamburgGermanyActive, not recruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyActive, not recruiting
Universitaetsklinikum Mannheim GmbH
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MannheimGermanyActive, not recruiting
Rigshospitalet
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Copenhagen OeDenmarkRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainRecruiting
Hospital Universitario HM Sanchinarro
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MadridSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Infantil Universitario Nino Jesus
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MadridSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Centre Leon Berard
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LyonFranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceActive, not recruiting
Institut Curie
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ParisFranceActive, not recruiting
Institut Gustave Roussy
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VillejuifFranceActive, not recruiting
Orszagos Onkologiai Intezet
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Budapest XIIHungaryCompleted
University of Debrecen
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DebrecenHungaryCompleted
Novartis Investigative Site
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Chuo KuJapanCompleted
Novartis Investigative Site
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KashiwaJapanCompleted
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsRecruiting
Novartis Investigative Site
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MoscowRussiaRecruiting
Novartis Investigative Site
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SongkhlaThailandActive, not recruiting
National Institute Of Health
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BethesdaUnited StatesActive, not recruiting
James Cancer Hospital and Solove Research Institute Ohio State
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ColumbusUnited StatesCompleted
Mary Crowley Cancer Research
Coordinator of this site? Confirm its status
DallasUnited StatesCompleted
Honor Health Research Institute
Coordinator of this site? Confirm its status
ScottsdaleUnited StatesActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.