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Dabrafenib and/or Trametinib Rollover Study

RecruitingPhase 4Ages 18 Years - 100 YearsAllNovartis Pharmaceuticals
NCT03340506 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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: * 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.
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What it tests

  • dabrafenib
  • trametinib
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Where

38 sites
Honor Health Research Institute
Scottsdale, United States
National Institute Of Health
Bethesda, United States
James Cancer Hospital and Solove Research Institute Ohio State
Columbus, United States
Mary Crowley Cancer Research
Dallas, United States
Novartis Investigative Site
Caba, Argentina
Novartis Investigative Site
Innsbruck, Austria
Novartis Investigative Site
Toronto, Canada
Novartis Investigative Site
Beijing, China

…and 30 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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