Access to continued treatment with dabrafenib and/or trametinib for eligible patients

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 for patients with melanoma, lung cancer, or other solid tumors who have been doing well on dabrafenib and/or trametinib and want to keep getting these treatments without a break.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Drugs / interventions: trametinib
• Locations: 28 sites (Scottsdale, Arizona and 27 other locations)
• Trial ID: NCT03340506 on ClinicalTrials.gov

What this trial studies

This study provides ongoing access to patients who have been receiving treatment with dabrafenib and/or trametinib in previous Novartis or former GSK-sponsored studies. It aims to allow patients who have met the primary objectives of those studies and are deemed by investigators to benefit from continued treatment to remain on these therapies. The study focuses on patients with conditions such as melanoma, non-small cell lung cancer, and other solid tumors. It is designed to ensure that patients who have shown positive responses can continue their treatment without interruption.

Who should consider this trial

Good fit: Ideal candidates are patients currently receiving dabrafenib and/or trametinib in a qualifying study who are judged by their investigator to benefit from ongoing treatment.

Not a fit: Patients who have been permanently discontinued from study treatment in the parent protocol or whose indication is commercially available may not receive benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with continued access to effective cancer treatments that they have already benefited from.

How similar studies have performed: Other studies involving dabrafenib and trametinib have shown success in treating similar conditions, indicating a promising approach.

Eligibility criteria

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.

Where this trial is running

Scottsdale, Arizona and 27 other locations

• Honor Health Research Institute — Scottsdale, Arizona, United States (Active_not_recruiting)
• Honor Health Research Institute — Scottsdale, Arizona, United States (Recruiting)
• National Institute Of Health — Bethesda, Maryland, United States (Active_not_recruiting)
• James Cancer Hospital and Solove Research Institute Ohio State — Columbus, Ohio, United States (Completed)
• Mary Crowley Cancer Research — Dallas, Texas, United States (Completed)
• Novartis Investigative Site — Caba, Buenos Aires, Argentina (Completed)
• Novartis Investigative Site — Innsbruck, Tyrol, Austria (Active_not_recruiting)
• Novartis Investigative Site — Beijing, China (Completed)
• Novartis Investigative Site — Copenhagen, Denmark (Active_not_recruiting)
• Novartis Investigative Site — Lyon, France (Active_not_recruiting)
• Novartis Investigative Site — Nantes, France (Active_not_recruiting)
• Novartis Investigative Site — Paris, France (Completed)
• Novartis Investigative Site — Villejuif, France (Completed)
• Novartis Investigative Site — Mannheim, Baden-Wurttemberg, Germany (Completed)
• Novartis Investigative Site — Berlin, Germany (Completed)
• Novartis Investigative Site — Hamburg, Germany (Completed)
• Novartis Investigative Site — Heidelberg, Germany (Active_not_recruiting)
• Novartis Investigative Site — Debrecen, Hajdu Bihar Megye, Hungary (Completed)
• Novartis Investigative Site — Budapest, Hungary (Completed)
• Novartis Investigative Site — Kashiwa, Chiba, Japan (Completed)
• Novartis Investigative Site — Chuo Ku, Tokyo, Japan (Completed)
• Novartis Investigative Site — Rotterdam, South Holland, Netherlands (Completed)
• Novartis Investigative Site — Utrecht, Netherlands (Active_not_recruiting)
• Novartis Investigative Site — Barcelona, Spain (Recruiting)
• Novartis Investigative Site — Madrid, Spain (Recruiting)
• Novartis Investigative Site — Madrid, Spain (Completed)
• Novartis Investigative Site — Madrid, Spain (Recruiting)
• Novartis Investigative Site — Songkhla, Hat Yai, Thailand (Active_not_recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Melanoma; Non Small Cell Lung Cancer; Solid Tumor; Rare Cancers; High Grade Glioma; Tafinlar; Mekinist; Dabrafenib