Special Drug Use-results Surveillance of Tafinlar/Mekinist

Recruiting now

Conditions studied: BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor

In brief

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.

Key facts

Study ID

NCT06262919

Run by

Novartis Pharmaceuticals

People needed

110

Starts

2024-02-09

Expected to finish

2031-12-31

Last updated by the study team

2026-06-17

Who can join

Age: 6 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Kawagoe, Saitama, Japan (enrolling)
• Novartis Investigative Site — Sunto Gun, Shizuoka, Japan (enrolling)
• Novartis Investigative Site — Okayama, Okayama-ken, Japan (enrolling)
• Novartis Investigative Site — Takatsuki, Osaka, Japan (enrolling)
• Novartis Investigative Site — Saitama, Saitama, Japan (enrolling)
• Novartis Investigative Site — Ohtsu, Shiga, Japan (enrolling)
• Novartis Investigative Site — Sendai, Miyagi, Japan (enrolling)
• Novartis Investigative Site — Yufu, Oita Prefecture, Japan (enrolling)
• Novartis Investigative Site — Osaka, Osaka, Japan (enrolling)
• Novartis Investigative Site — Yoshida-gun, Fukui, Japan (enrolling)
• Novartis Investigative Site — Fukuoka, Fukuoka, Japan (enrolling)
• Novartis Investigative Site — Kurume, Fukuoka, Japan (enrolling)
• Novartis Investigative Site — Fukuyama, Hiroshima, Japan (enrolling)
• Novartis Investigative Site — Sapporo, Hokkaido, Japan (enrolling)
• Novartis Investigative Site — Sapporo, Hokkaido, Japan (enrolling)
• Novartis Investigative Site — Nagoya, Aichi-ken, Japan (enrolling)
• Novartis Investigative Site — Matsumoto, Nagano, Japan (enrolling)
• Novartis Investigative Site — Kobe, Hyōgo, Japan (enrolling)
• Novartis Investigative Site — Mito, Ibaraki, Japan (enrolling)
• Novartis Investigative Site — Kashiwa, Chiba, Japan (enrolling)
• Novartis Investigative Site — Sagamihara, Kanagawa, Japan (enrolling)
• Novartis Investigative Site — Yokohama, Kanagawa, Japan (enrolling)
• Novartis Investigative Site — Yokohama, Kanagawa, Japan (enrolling)
• Novartis Investigative Site — Kyoto, Kyoto, Japan (enrolling)
• Novartis Investigative Site — Bunkyo Ku, Tokyo, Japan (enrolling)

Full record on ClinicalTrials.gov

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