Dabrafenib and/or Trametinib Rollover Study (NCT03340506)
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-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (4 items).
Location: Honor Health Research Institute — Scottsdale, Arizona
Age range: 18 Years to 100 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (33 Sites)
Showing the first 25 of 33 sites.
- Honor Health Research Institute — Scottsdale, Arizona
- National Institute Of Health — Bethesda, Maryland
- James Cancer Hospital and Solove Research Institute Ohio State — Columbus, Ohio
- Mary Crowley Cancer Research — Dallas, Texas
- Novartis Investigative Site — Caba, Buenos Aires
- Novartis Investigative Site — Innsbruck, Tyrol
- Novartis Investigative Site — Beijing,
- Novartis Investigative Site — Copenhagen,
- Novartis Investigative Site — Lyon,
- Novartis Investigative Site — Nantes,
- Novartis Investigative Site — Paris,
- Novartis Investigative Site — Paris,
- Novartis Investigative Site — Villejuif,
- Novartis Investigative Site — Mannheim, Baden-Wurttemberg
- Novartis Investigative Site — Augsburg,
- Novartis Investigative Site — Berlin,
- Novartis Investigative Site — Essen,
- Novartis Investigative Site — Hamburg,
- Novartis Investigative Site — Hamburg,
- Novartis Investigative Site — Heidelberg,
- Novartis Investigative Site — Debrecen, Hajdu Bihar Megye
- Novartis Investigative Site — Budapest,
- Novartis Investigative Site — Kashiwa, Chiba
- Novartis Investigative Site — Chuo Ku, Tokyo
- Novartis Investigative Site — Rotterdam, South Holland
📞 Contact the Study Coordinator
Phone: (888) 669-6682
Email: novartis.email@novartis.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.