Special Drug Use-results Surveillance of Tafinlar/Mekinist
Recruiting
Observational Study
BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
6 – 99
Sex
Any
Study type
Observational
Participants needed
110 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for
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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.
Trial Locations
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Status
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 t…
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
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