Special Drug Use-results Surveillance of Tafinlar/Mekinist

Launched by NOVARTIS PHARMACEUTICALS · Feb 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called Tafinlar/Mekinist in patients who have certain types of advanced or recurrent solid tumors that are positive for a specific genetic change known as the BRAF V600E mutation. The trial is non-interventional, meaning it is observing how patients respond to the treatment without altering their standard care. It is currently recruiting participants of all ages, from 2 to 36 years old, who have agreed to join the study.

To be eligible, participants must provide written consent to take part, and if they are under 18, a parent or guardian must also agree. The trial is specifically looking for patients who have these advanced tumors but excludes those with certain other types of cancers, like melanoma or lung cancer. Participants can expect to be monitored closely throughout the trial to understand how well the medication works for them. This is an important step in gathering information on the safety and effectiveness of Tafinlar/Mekinist for these patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients who have given written consent to cooperate in this surveillance
• • 2. 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.
• • 3. 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 Criteria:
• • 1. 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
• • 2. Patients with BRAF-mutation-positive malignant melanoma
• • 3. Patients with BRAF-mutation-positive non-small cell lung cancer
• • 4. Patients with BRAF-mutation-positive hairy cell leukemia