Fukuyama, Hiroshima, Japan
Special Drug Use-results Surveillance of Tafinlar/Mekinist
In the Post-Marketing Surveillance (PMS), dabrafenib and trametinib are used as the marketed drugs. Registration of the corresponding patients is to be conducted by the central registered system under current medical practice. Target number of adult patient is 65 (as the number of patients in the effectiveness analysis set). Target number of pediatric patient is not determined. Estimated number of enrolled patients is approximately 20 (as the number of patients in the enrolled set) The observation period for pediatric patients will last after the start of treatment until 8 years (planned, November 2031) after the approval of additional indications, regardless of discontinuation of the product, in order to collect long-term information from as many patients as possible during the reexamination period. The duration of observation for adult patients will be 1 year after the start of treatment with the product.
Phase
N/ASpan
412 weeksSponsor
Novartis PharmaceuticalsFukuyama, Hiroshima
Recruiting
Fukuyama, Hiroshima
Recruiting
Fukuyama, Hiroshima
Recruiting
A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)
The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.
Phase
3Span
321 weeksSponsor
Merck Sharp & Dohme LLCFukuyama, Hiroshima
Recruiting
A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Phase
3Span
228 weeksSponsor
Eli Lilly and CompanyFukuyama, Hiroshima
Recruiting
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
Phase
3Span
496 weeksSponsor
Eli Lilly and CompanyFukuyama, Hiroshima
Recruiting
Fukuyama, Hiroshima
Recruiting
A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.
Phase
3Span
284 weeksSponsor
Merck Sharp & Dohme LLCFukuyama, Hiroshima
Recruiting
Fukuyama, Hiroshima
Recruiting
Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
This is a clinical trial to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 36 cycles) on the primary endpoint of overall survival (OS) in adult patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML). Participants will be tested for FLT3-ITD mutation status in a central laboratory using a validated assay.
Phase
3Span
293 weeksSponsor
Daiichi SankyoFukuyama
Recruiting