There are about 7997 clinical studies being (or have been) conducted in Japan. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The primary objective of Part A is to evaluate the safety and tolerability of S-531011 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of S-531011. The primary objective of Parts B and C is to evaluate the antitumor activity of S-531011 at the RP2D.
This study is a survey in Japan of Brigatinib tablets used to treat Japanese people with non-small cell lung cancer. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for side effects related to lung disease from Brigatinib. During the study, participants with non-small cell lung cancer will take Brigatinib tablets according to their clinic's standard practice. The study doctors will check for side effects from Brigatinib for 1 year.
This study is a genetic analysis of aberrations in circulating tumor DNA (ctDNA) in patients in Asian countries. This study protocol is divided into parts describing several subanalyses that differ in terms of cancer types, analytical methods, participating countries, and participating institutions.
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC), a group of lung cancers that have spread to nearby tissues or to other parts of the body. Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and/or HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and/or HER2 mutations exist in the cancer cells. The study treatment, BAY2927088, is expected to block the mutated EGFR and HER2 proteins which may stop the spread of NSCLC. The main purpose of this study is to learn: Escalation, Backfill, and Expansion Part: - How safe is BAY2927088 for the participants? - What is the highest dose of BAY2927088 that can be tolerated (maximum tolerated dose) by or given to (maximum administered dose) the participants? - How does BAY2927088 move into, through, and out of the bodies of the participants? For this, the researchers will measure the followings: - The number of participants with medical problems, also called adverse events and serious adverse events, and their severity - The number of participants who discontinue study treatment due to an adverse event. - The highest dose of BAY2927088 that the participants can take without having adverse events (maximum tolerated dose (MTD)) or the maximum dose that is tested and found to be safe for the participants in case MTD cannot be found out (maximum administered dose (MAD)) of BAY2927088 - Number of participants experiencing adverse events that prevent an increase in the dose of BAY2927088 (dose-limiting toxicities (DLTs)) at each dose level - The (average) total level of BAY2927088 in the blood (also called AUC) after receiving single or multiple doses of BAY 2927088 - The (average) highest level of BAY 2927088 in the blood (also called Cmax) after receiving a single or multiple doses of BAY2927088 Extension Part - How well does BAY 2927088 work in participants? For this, the researchers will measure the following: • Percentage of participants whose cancer completely disappears (complete response) or reduces by at least 30% (partial response) after taking the treatment (also known as objective response rate (ORR)). This will be assessed by doctors other than the study doctor. This study has 4 parts: - The escalation part aims to find the maximum daily amount (dose) of BAY2927088 that participants can receive. - The backfill part aims to test the doses of BAY2927088 that are considered safe in the escalation part by giving it to more participants. This will help find optimal doses of BAY 2927088 that work well and are safe to be tested in the next part. - The expansion part aims to determine the dose of BAY2927088 to be tested in further studies. - The extension part aims to determine whether the selected dose of BAY2927088 from the expansion part works well. The participants in this study will take the study treatment BAY2927088 in 3-week periods called "cycles". They will in general take BAY2927088 once or twice daily as a liquid/tablet by mouth until their cancer gets worse, they have medical problems, they leave the study, or the study is terminated. Participants will have no more than 5 visits per cycle. During the study, the study team will: - take blood and urine samples, - check the status of the cancer by doing computed tomography (CT) or magnetic resonance imaging (MRI) scans, - check the participants' overall health and heart health, - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is considered "serious" when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important.
The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AMG 193 alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors. The primary objective of Part 3 of this study is to evaluate the objective response rate (ORR) of AMG 193 in adult participants with metastatic or locally advanced MTAP-null solid tumors.
The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab
The administration of Janus kinase (JAK) inhibitors as well as biological disease-modifying anti-rheumatic drugs has dramatically improved even the clinical outcomes in rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX). The dysregulation of JAK-signal transducer and activator of transcription (STAT) pathways via overproduction of cytokines, such as interleukin-6 (IL-6) is involved in the pathogenesis of RA. Filgotinib is a selective JAK1 inhibitor to be approved for use in RA. Filgotinib is effective in suppressing disease activity and preventing the progression of joint destruction due to inhibition of the JAK-STAT pathway. IL-6 inhibitors such as tocilizumab also inhibit the JAK-STAT pathways due to inhibition of IL-6 signaling. We will evaluate whether the effectiveness and safety of filgotinib monotherapy is non-inferior to those of tocilizumab monotherapy in RA patients with inadequate response to MTX.
The primary objectives of this study are to determine the safety and tolerability of DRF administered for up to 24 weeks in adult East Asian participants with RMS (Part 1) and to determine the safety and tolerability of DRF administered for up to 48 weeks in adult East Asian participants with RMS (Part 2). The secondary objective of this study is to evaluate the pharmacokinetic(s) (PK) of DRF metabolites (monomethyl fumarate [MMF] and 2-hydroxyethyl succinimide [HES]) following multiple doses of DRF in a subset of adult East Asian participants with RMS (Part 1).
Immune therapies work with the body's immune system to treat a number of cancers. They work with T-cells, a type of white blood cell, to target and attack specific tumors. However, some tumors can become resistant to attack by T-cells over time. They do this by sending "off" signals to T-cells. The researchers are finding ways to switch the T-cells back on. Early studies have shown that ASP1570 can switch T-cells back on to attack tumors. This study will provide more information on this potential new treatment in adults with advanced solid tumors. Their tumor has either grown outside of the area where it started (locally advanced and unresectable) or it has spread to other parts of the body (metastatic). Their cancer gets worse after standard therapy or they are unable to have standard therapy. People will either be treated with ASP1570 by itself, or together with another medicine called pembrolizumab. This study will be in 2 parts. In Part 1, the best dose of ASP1570 to give to people with advanced solid tumors will be worked out. Different small groups of people with advanced solid tumors will take lower to higher doses of ASP1570 by itself or with pembrolizumab. There are different doses of ASP1570, with each group staying on the same dose. There is just 1 dose of pembrolizumab. After taking the lowest dose of ASP1570, the first group will be checked for medical problems. The next group can only take the higher dose of ASP1570 if the first group on the lowest dose had no major medical problems. This will continue in the same way for each group. This means each group will take the next highest dose of ASP1570 as long as the previous group did not have any major medical problems. Each group will take tablets of ASP1570 either once or twice every day in a 21-day cycle. People taking part in Japan will stay in hospital for up to 21 days during the first treatment cycle only. People will continue with more treatment cycles on the same dose unless they have major medical problems, their cancer gets worse or the study doctor decides that person should stop treatment. People who are also receiving treatment with pembrolizumab will be infused with pembrolizumab on the first day of every other cycle of ASP1570 (once every 6 weeks). In Part 2, different small groups of people with advanced solid tumors will take the best dose of ASP1570 worked out from Part 1. The dose will not go above the highest dose that people took in Part 1 without getting major medical problems. Some groups of people will have specific advanced tumors. These include tumors from metastatic melanoma or non-small cell lung cancer (NSCLC for short). Other groups will have solid tumors that showed a response in Part 1. Again, each group will take tablets of ASP1570 once or twice every day in a 21-day cycle. Only people with NSCLC will also be infused with pembrolizumab on the first day of every other cycle of ASP1570 (once every 6 weeks). All groups will continue with more treatment cycles with ASP1570 by itself or with pembrolizumab, unless they have major medical problems, their cancer gets worse or the study doctor decides that person should stop treatment. After treatment with ASP1570, people in the study will visit their clinic 45 days after their last dose of ASP1570. People who were treated with ASP1570 and pembrolizumab will visit their clinic either 45 days after their last dose of ASP1570 or 30 days after their last dose of pembrolizumab. It will depend on which treatment was the last one they had. Then, the study clinic will contact each person in the study at least every 12 weeks until the end of the study or if they decide to leave the study.
The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration.