Nagawa

Researchers are evaluating MT-4561, an investigational drug, in adults with various advanced solid tumors including head and neck, lung, esophageal, gastric, biliary tract, pancreatic, breast, ovarian, cervical, endometrial, prostate, urothelial, neuroendocrine tumors, soft tissue sarcoma, and NUT carcinoma. This Phase III study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and effectiveness of MT-4561 in patients who have exhausted other treatment options or cannot tolerate standard therapies. The study is sponsored by Tanabe Pharma America, Inc. The study is conducted in three parts. Part 1 focuses on finding the maximum tolerated dose using a dose-escalation design with weekly intravenous infusions of MT-4561 in 28-day cycles until disease progression or stopping criteria are met. Parts 2 and 3 will explore dose optimization and drug interactions after reviewing Part 1 results. Participants receive the study drug via intravenous infusion once a week during each 28-day cycle. Participants will be regularly monitored for side effects, dose-limiting toxicities, and drug levels in blood. Researchers will assess tumor response and disease control over approximately three years. Evaluations include physical exams, lab tests, and imaging to measure tumor changes, survival, and duration of disease stability. The study includes screening, treatment cycles, and follow-up visits to track safety and outcomes throughout the trial period.

Researchers are observing adult Japanese men with low-volume metastatic hormone-sensitive prostate cancer mHSPC who are receiving a combination therapy of darolutamide, androgen deprivation therapy ADT, and docetaxel during routine medical care. This study aims to understand the safety and effects of this combination therapy in real-world clinical settings, as darolutamide is approved for a related prostate cancer type but requires further study for this specific group. Participants receive darolutamide together with ADT and docetaxel as prescribed by their doctors in standard medical practice. No treatment changes or advice are given as part of the study. Data collection occurs from October 2024 to June 2031, drawing from medical records without any extra visits or interventions required for participants. Participants will continue their usual care visits, and researchers will gather information from medical records to assess prostate-specific antigen PSA levels, adverse events related to treatment, and other clinical outcomes over 12 months. The main outcomes include the proportion of patients achieving normal PSA levels and the frequency of adverse events leading to changes or discontinuation of darolutamide or docetaxel. Secondary measures include time to PSA progression, development of castration-resistant prostate cancer, and treatment patterns among others.

This observational study focuses on Japanese people with chronic heart failure who are receiving the drug vericiguat. Chronic heart failure is a long-term condition where the heart does not pump blood effectively, which can lead to serious health issues, hospitalization, or death. Researchers aim to learn more about the safety of vericiguat in a broader Japanese population and during prolonged treatment, especially since limited patients have received this drug so far. Participants include those who will start vericiguat therapy alongside standard treatment and those continuing standard care without vericiguat. The dosing of vericiguat is determined by the treating physician based on approved product information. The study collects data from medical records and electronic forms during routine medical visits over a period of up to two years. It compares the safety and cardiovascular outcomes, such as death from heart-related causes, between those treated with vericiguat and those receiving standard care. During the study, researchers will document participants medical history, treatments, laboratory results, vital signs, cardiac exam results, hospitalizations related to heart failure, and any adverse events experienced. The studys main focus is on the severity, seriousness, outcome, and causes of adverse events related to vericiguat treatment. The total study duration, including data analysis, is six years, allowing for long-term safety monitoring and evaluation of treatment effects.

Researchers are evaluating the efficacy and safety of duvakitug, a drug given by subcutaneous injection, in people with moderately to severely active Ulcerative Colitis UC. This Phase 3 randomized, double-blind, placebo-controlled study includes participants aged 16 to 80 years and aims to assess clinical remission and other health improvements over a series of treatment periods. The study lasts up to 35 weeks and includes a screening period followed by three possible sub-studies a 12-week open-label induction, a 12-week pivotal induction, and a 12-week extended induction for those who do not respond initially. Participants receive injections of either duvakitug at one of two doses or placebo according to the study protocol, with up to 15 visits scheduled for those in extended induction. During the study, participants will undergo assessments including clinical remission rates at week 12, endoscopic and histological improvements, symptom tracking, quality of life questionnaires, and safety monitoring for adverse events. Follow-up visits occur up to 45 days after the last dose for those not continuing in the maintenance study. Researchers will also measure drug levels and immune responses over the study period to better understand treatment effects.

Researchers are studying people in Asia and the United States who have chronic kidney disease CKD along with type 2 diabetes T2D to understand more about the use, safety, and effectiveness of the treatment finerenone in real-world settings. CKD is a long-term condition where the kidneys progressively lose function, and T2D is a condition where the body does not produce or use insulin properly, leading to high blood sugar that can damage the kidneys. Finerenone blocks certain proteins called mineralocorticoid receptors, which may help protect the kidneys, heart, and blood vessels. It was recently approved for use in the US, and this observational study aims to collect information on people receiving finerenone as part of their regular care. The study uses data from commercial electronic health records and national claims databases in Asia and the US, covering the period from July 1, 2021, to the most recent available data. Participants are adults with CKD and T2D who have started finerenone treatment prescribed by their doctors. Since this is an observational study, no new treatments or interventions are given by the researchers. Instead, the study collects existing data on participants, including their kidney function, heart health, other medical conditions, and medications used while on finerenone. Participants are not required to attend any study visits or tests specifically for this research. The researchers use already available health records to analyze participant characteristics, comorbidities, and medication use before and after starting finerenone. They also monitor outcomes such as kidney failure, cardiovascular events, and medication dosing over time. The study will continue until September 30, 2026, gathering long-term real-world information about finerenone use and safety in people with CKD and T2D.

Researchers are conducting a phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of KPS-0373 in patients with spinocerebellar degeneration. The study involves 142 patients with mild to moderate ataxia related to this condition. Participants will be followed through screening, treatment, and follow-up periods to assess treatment effects. The study includes three phases a 4-week screening period where all participants receive a placebo tablet once daily after breakfast a 24-week treatment period where patients are randomly assigned to receive either KPS-0373 2.4 mg or placebo once daily after breakfast and a 4-week follow-up period after treatment. Both study groups will take oral tablets daily, allowing comparison of KPS-0373 against placebo. Participants will undergo assessments including the Scale for the Assessment and Rating of Ataxia SARA to measure changes in ataxia symptoms at 24 weeks, along with other secondary measurements like quality of life questionnaires SF-8. Researchers will monitor safety and symptom changes throughout the study. The total duration of participation spans approximately 32 weeks from screening through follow-up.

Researchers are studying larotrectinib as a treatment for people of all ages with advanced or recurring TRK fusion cancer, a type of cancer caused by a specific gene fusion that leads to cancer cell growth. This research aims to gather real-world information about how larotrectinib affects patients when used as part of their regular medical care. Participants receive larotrectinib prescribed by their doctors according to usual clinical practice. The study does not require extra visits or tests beyond what patients normally have during their treatment. Researchers will collect data from medical records, interviews with patients or their guardians, and regular doctor visits. The study includes various cancer types such as gastrointestinal, head and neck, lung, soft tissue sarcoma, central nervous system, and melanoma. During the study, researchers will monitor patients for up to about 2 years for adults and 8 years for children. They will track treatment-related side effects, their severity, frequency, seriousness, and outcomes, as well as assess how the cancer responds to larotrectinib. Information like neurological exams, growth changes in children, and overall survival will also be collected to better understand the long-term effects and safety of larotrectinib in routine care.

This research aims to evaluate the long-term safety and effectiveness of avacopan in Japanese patients diagnosed with microscopic polyangiitis or granulomatosis with polyangiitis. These conditions involve inflammation of blood vessels and the study focuses on real-world use of the medication. The survey is observational and tracks patients over time to gather important information on treatment outcomes. Participants receive avacopan through oral administration as part of their treatment. The study observes patients who are already being treated with avacopan to assess its impact under normal usage conditions. There are no comparison groups or placebo treatments, as this is a drug use-results survey. During the study, researchers monitor adverse events and overall patient safety for up to two years. Data collection includes recording any side effects or health changes related to avacopan. The goal is to better understand the medications safety profile during long-term use in this patient population. Participants remain under their usual medical care throughout the survey.

Researchers are conducting a prospective, observational, multi-center study to assess the safety and effectiveness of Eylea Aflibercept injection in patients diagnosed with Neovascular Glaucoma in Japan. This study focuses on patients for whom the decision to use Eylea has already been made by their doctors in routine clinical practice. The goal is to collect real-world data on how patients respond to this treatment over time. Participants receive Eylea through intravitreal injection as part of their usual care, with the treatment decision guided by the Japanese package insert. The study does not assign treatments but observes patients who have been prescribed Eylea. Patients are followed for up to six months from the start of their Eylea treatment or until they can no longer be followed, such as if they are lost to follow-up. During the study, data are collected at initial, follow-up, and final visits, aligned with routine medical appointments. Researchers assess safety by recording any adverse events and monitor effectiveness by measuring intraocular pressure, visual acuity changes, and improvements in anterior neovascularization. In total, 480 patients will be included, providing valuable information about Eyleas use in everyday clinical settings.

Researchers are investigating how well the drug VITRAKVI generic name larotrectinib works and how well patients tolerate it in real-world use for those with TRK fusion cancer. This cancer type involves a genetic change called an NTRK gene fusion that can cause tumors to grow. The study includes adults and children with locally advanced or metastatic solid tumors that have this specific gene fusion, reflecting a variety of common and rare cancers. Patients enrolled in this observational study are those for whom their doctors have decided to treat with larotrectinib. Treatments and medical care follow local standard practices without interference from the study. Participants are grouped based on cancer types like gastrointestinal, head and neck, soft tissue sarcoma, CNS, lung, melanoma, pediatric tumors, and others. Data on treatments, other medications, disease changes, and health symptoms will be collected during routine care. Participants will be observed for 24 to 60 months. Researchers will collect information on treatment side effects up to 30 days after treatment ends and monitor responses, disease control, survival, doses, and developmental milestones for up to 8 years. Medical records, including height, weight, neurological assessments, and Tanner stage will be reviewed as part of this long-term observation.