Monitoring the use of Tafinlar and Mekinist in patients with specific tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect data on the effectiveness and safety of Tafinlar (dabrafenib) and Mekinist (trametinib) in patients with BRAF V600E mutation-positive unresectable advanced or recurrent solid tumors. It will involve a multicenter approach where patients will be registered in a central system and monitored over a specified period. The study will include both adult and pediatric patients, with adults observed for one year and pediatric patients for up to eight years to gather long-term data. The goal is to assess the real-world outcomes of these treatments in a clinical setting.

Why it matters

Who can join: the full rules

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

Where it's running

• Novartis Investigative Site
  Nagoya, Aichi-ken, Japan Recruiting
• Novartis Investigative Site
  Kashiwa, Chiba, Japan Recruiting
• Novartis Investigative Site
  Yoshida-gun, Fukui, Japan Recruiting
• Novartis Investigative Site
  Fukuoka, Fukuoka, Japan Recruiting
• Novartis Investigative Site
  Kurume, Fukuoka, Japan Recruiting
• Novartis Investigative Site
  Fukuyama, Hiroshima, Japan Recruiting

+20 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +81337978748

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.