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
Novartis Pharmaceuticals
110 participants
Feb 9, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Patients who have given written consent to cooperate in this surveillance
- For patients aged < 18 years at the start of treatment with the product, their legally authorized representative must have given written informed consent for cooperation in this surveillance prior to patient enrollment.
- Patients who start treatment with the product for BRAF-mutation-positive advanced/recurrent solid tumors (excluding colorectal cancer) after the approval of additional indications
Exclusion Criteria4
- Patients who have received or are receiving a product containing the same ingredient as the product in any other study or research than this surveillance
- Patients with BRAF-mutation-positive malignant melanoma
- Patients with BRAF-mutation-positive non-small cell lung cancer
- Patients with BRAF-mutation-positive hairy cell leukemia
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Interventions
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.
Locations(68)
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NCT06262919