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Clinical Trials in Japan / NCT06262919
Recruiting Observational

Special Drug Use-results Surveillance of Tafinlar/Mekinist

NCT06262919 · tracked via the Priya Life Science Japan tracker
Sponsor
Novartis Pharmaceuticals
Phase
Observational
Started
2024-02-09
Last updated
2026-06-17

Condition(s) studied

BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor

Investigational drug(s) / intervention(s)

Tafinlar/Mekinist →

Tafinlar/Mekinist: There is no treatment allocation. Patients administered Tafinlar/Mekinist by prescription that have started before inclusion of the patient into the study will be enrolled.

Study summary

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

Sex
ALL
Min age
6 Years
Max age
99 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • [Pediatric patients] Number of patients and incidence of adverse events/adverse reactions with respect to skeletal and sexual maturation — Up to 8 years
    To evaluate impairment in growth and development in pediatric patients (skeletal and sexual maturation) of dabrafenib and/or trametinib in pediatric patients under 18 years old in the post marketing phase.
  • [Adult patients] overall response rate (ORR) — 1 year
    The Overall Response Rate (ORR) is defined as the proportion of patients with a best OR of confirmed Complete Response (CR) or Partial Response (PR)

Trial sites (70)

FacilityCityRegionStatus
Novartis Investigative Site Nagakute Aichi-ken Completed
Novartis Investigative Site Nagoya Aichi-ken Recruiting
Novartis Investigative Site Nagoya Aichi-ken Completed
Novartis Investigative Site Nagoya Aichi-ken Completed
Novartis Investigative Site Toyohashi Aichi-ken Completed
Novartis Investigative Site Toyota Aichi-ken Completed
Novartis Investigative Site Daisen Akita Completed
Novartis Investigative Site Chiba Chiba Withdrawn
Novartis Investigative Site Funabashi Chiba Completed
Novartis Investigative Site Kashiwa Chiba Recruiting
Novartis Investigative Site Yoshida-gun Fukui Recruiting
Novartis Investigative Site Fukuoka Fukuoka Recruiting
Novartis Investigative Site Kurume Fukuoka Recruiting
Novartis Investigative Site Fukuyama Hiroshima Recruiting
Novartis Investigative Site Sapporo Hokkaido Recruiting
Novartis Investigative Site Sapporo Hokkaido Recruiting
Novartis Investigative Site Amagasaki Hyōgo Completed
Novartis Investigative Site Kobe Hyōgo Completed
Novartis Investigative Site Kobe Hyōgo Recruiting
Novartis Investigative Site Mito Ibaraki Recruiting
Novartis Investigative Site Morioka Iwate Completed
Novartis Investigative Site Sagamihara Kanagawa Recruiting
Novartis Investigative Site Yokohama Kanagawa Recruiting
Novartis Investigative Site Yokohama Kanagawa Recruiting
Novartis Investigative Site Kyoto Kyoto Recruiting
Novartis Investigative Site Natori-shi Miyagi Completed
Novartis Investigative Site Sendai Miyagi Recruiting
Novartis Investigative Site Iida Nagano Active Not Recruiting
Novartis Investigative Site Matsumoto Nagano Recruiting
Novartis Investigative Site Matsumoto Nagano Completed
Novartis Investigative Site Yufu Oita Prefecture Recruiting
Novartis Investigative Site Okayama Okayama-ken Recruiting
Novartis Investigative Site Habikino Osaka Active Not Recruiting
Novartis Investigative Site Izumisano Osaka Completed
Novartis Investigative Site Osaka Osaka Recruiting
Novartis Investigative Site Osaka Osaka Completed
Novartis Investigative Site Osaka Osaka Completed
Novartis Investigative Site Takatsuki Osaka Recruiting
Novartis Investigative Site Kawagoe Saitama Recruiting
Novartis Investigative Site Saitama Saitama Recruiting

+ 30 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in Japan

A Study of Ruxolitinib in Patients With Graft-Versus Host Disease Recruiting
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. Recruiting
Evaluate Long-term Safety, Tolerability and Efficacy of Iptacopan in Study Participants With aHUS Recruiting
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines Active, not recruiting
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06262919 on ClinicalTrials.gov ↗ ← All trials in Japan