NCT06262919

Special Drug Use-results Surveillance of Tafinlar/Mekinist

Observational Study to Assess Safety and Effectiveness of Dabrafenib and Trametinib in Patients With BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 110 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 6 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, single-arm, non-interventional and observational J-PMS conducted by the central registration system and operated in Electronic data capture.

Detailed description

In the Post-Marketing Surveillance (PMS), dabrafenib and trametinib are used as the marketed drugs. Registration of the corresponding patients is to be conducted by the central registered system under current medical practice. Target number of adult patient is 65 (as the number of patients in the effectiveness analysis set). Target number of pediatric patient is not determined. Estimated number of enrolled patients is approximately 20 (as the number of patients in the enrolled set) The observation period for pediatric patients will last after the start of treatment until 8 years (planned, November 2031) after the approval of additional indications, regardless of discontinuation of the product, in order to collect long-term information from as many patients as possible during the reexamination period. The duration of observation for adult patients will be 1 year after the start of treatment with the product.

Conditions

• BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor

Interventions

Type	Name	Description
DRUG	Tafinlar/Mekinist	There is no treatment allocation. Patients administered Tafinlar/Mekinist by prescription that have started before inclusion of the patient into the study will be enrolled.

Timeline

• Start date: 2024-02-09
• Primary completion: 2031-12-31
• Completion: 2031-12-31
• First posted: 2024-02-16
• Last updated: 2025-12-30

Locations

68 sites across 1 country: Japan