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Special Drug Use-results Surveillance of Tafinlar/Mekinist
Special Drug Use-results Surveillance of Tafinlar/Mekinist

NCT06262919

RecruitingN/A

Sponsor: Novartis Pharmaceuticals

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

Interventions: Tafinlar/Mekinist

Countries: Japan

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 overview

Sex: ALL

Age: 6 Years to 99 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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
Locations (70)
  • Nagakute, Aichi-ken, Japan
  • Nagoya, Aichi-ken, Japan
  • Nagoya, Aichi-ken, Japan
  • Nagoya, Aichi-ken, Japan
  • Toyohashi, Aichi-ken, Japan
  • Toyota, Aichi-ken, Japan
  • Daisen, Akita, Japan
  • Chiba, Chiba, Japan
  • Funabashi, Chiba, Japan
  • Kashiwa, Chiba, Japan
  • Yoshida-gun, Fukui, Japan
  • Fukuoka, Fukuoka, Japan
  • Kurume, Fukuoka, Japan
  • Fukuyama, Hiroshima, Japan
  • Sapporo, Hokkaido, Japan
  • Sapporo, Hokkaido, Japan
  • Amagasaki, Hyōgo, Japan
  • Kobe, Hyōgo, Japan
  • Kobe, Hyōgo, Japan
  • Mito, Ibaraki, Japan
  • Morioka, Iwate, Japan
  • Sagamihara, Kanagawa, Japan
  • Yokohama, Kanagawa, Japan
  • Yokohama, Kanagawa, Japan
  • Kyoto, Kyoto, Japan
  • Natori-shi, Miyagi, Japan
  • Sendai, Miyagi, Japan
  • Iida, Nagano, Japan
  • Matsumoto, Nagano, Japan
  • Matsumoto, Nagano, Japan
  • + 40 more on CT.gov