Yufu

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are evaluating the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of LY3962681 in both healthy volunteers and patients with Parkinson's disease. This study includes a Single Ascending Dose (SAD) phase with healthy volunteers and a Multiple Ascending Dose (MAD) phase involving Parkinson's patients to better understand the effects of the drug administered into spinal fluid. The study is a Phase 1 trial designed to gather important safety and dosage information for LY3962681 compared to a placebo (artificial cerebrospinal fluid). The study consists of two parts: the SAD study where healthy volunteers receive a single dose of LY3962681 or placebo via intrathecal (IT) injection, and the MAD study where Parkinson's patients receive two doses of LY3962681 or placebo spaced 12 to 24 weeks apart, also by IT injection. The treatment period lasts one day in the SAD study and two days in the MAD study. Follow-up for both parts extends up to 52 weeks after the last dose to monitor participants. Participants will undergo medical evaluations, including cognitive assessments and specific Parkinson's disease diagnostic tests for patients. The study monitors serious and treatment-emergent adverse events, as well as discontinuations due to side effects, for up to 76 weeks. Throughout the study, researchers will closely observe participants' safety, tolerability, and the body's processing of the drug to determine its effects over time.

Researchers are evaluating the safety, tolerability, and how the body processes the drug LY4006896 when given intravenously compared to a placebo in both healthy adults and adults with Parkinson's disease. This Phase 1 study aims to generate evidence on these aspects to better understand the effects of LY4006896 in these two groups. Participants include healthy individuals and those diagnosed with Parkinson's disease, reflecting a broad study population. Participants with Parkinson's disease undergo a screening period of up to 120 days and receive four doses of the study drug or placebo. Healthy participants have a shorter screening period of up to 35 days and receive a single dose. The treatment and follow-up last up to 61 weeks for Parkinson's disease participants and 48 weeks for healthy participants. Both LY4006896 and placebo are administered intravenously during the study. During the study, participants will have regular assessments including evaluations for any serious or treatment-emergent adverse events up to 48 weeks for healthy participants and 61 weeks for those with Parkinson's disease. Researchers will monitor safety, tolerability, and drug effects through blood sampling and clinical evaluations over a total duration of up to 78 weeks for Parkinson's disease participants and 53 weeks for healthy participants. Cognitive function and treatment stability are also monitored in Parkinson's disease participants.

Researchers are investigating the effectiveness and safety of mocravimod, a drug, as an additional and maintenance treatment for adults with acute myeloid leukemia (AML) who are undergoing allogeneic hematopoietic cell transplantation (HCT). This phase III, multi-center, randomized, double-blinded, placebo-controlled trial focuses on adult AML patients classified as high-risk or intermediate-risk, including those in their first or second remission. The study excludes patients with acute promyelocytic leukemia. Participants will receive mocravimod or a placebo alongside their transplantation procedure. The treatment is given as an adjunctive therapy during the transplantation process and continued as maintenance afterward. All participants will undergo planned allogeneic HCT from fully matched related or unrelated donors, or haploidentical donors using peripheral blood stem cell grafts. Conditioning regimens and GvHD prophylaxis based on tacrolimus (TAC) will be used as per protocol. Throughout the study, participants will be monitored for relapse-free survival over 12 months. Researchers will evaluate treatment safety and efficacy, with assessments including performance status and organ function. The total study duration includes transplantation, treatment, and follow-up periods to ensure comprehensive evaluation of mocravimod's role in this patient population.

Researchers are evaluating the long-term safety of ONO-4538 in participants with various types of tumors who are already receiving ONO-4538 either alone or combined with other therapies in clinical trials. This is a Phase II, open-label study involving patients continuing treatment with ONO-4538 after participating in previous trials assessing its efficacy and safety. Participants will receive ONO-4538 administered as an intravenous infusion over 30 minutes. Depending on their prior or ongoing treatments, some may also receive other drugs such as oxaliplatin (IV over 2 hours), S-1 or capecitabine (both taken orally twice daily), bevacizumab (IV infusion over 30 minutes), or temozolomide (oral daily for 5 days every 28 days). Treatments continue as per clinical trial protocols and investigator decisions. During the study, researchers will monitor participants for adverse events from the first day of treatment until 28 days after the treatment phase ends. Participants will be regularly assessed for safety and tolerability throughout their continued use of ONO-4538. The study focuses on long-term safety outcomes in patients treated with this drug regimen, with no maximum age limit specified and including both males and females aged 16 and older.

Researchers are evaluating the overall survival of women with stage I epithelial ovarian cancer following comprehensive staging surgery. This phase III trial compares the effects of adjuvant chemotherapy versus observation without chemotherapy in this patient group. Patients are randomly assigned based on histologic type, enrollment facility, and clinical staging according to the FIGO system. Participants are divided into two groups. Group A receives adjuvant chemotherapy, which includes either Paclitaxel plus Carboplatin or Docetaxel plus Carboplatin, administered every three weeks for three to six cycles. Switching between paclitaxel and docetaxel is allowed if adverse events occur. Group B undergoes observation only, with no chemotherapy given. The study treatment starts within eight weeks after comprehensive staging surgery. During the study, participants undergo regular assessments to monitor survival status up to 60 months from randomization. Researchers collect data including clinical evaluations, imaging, and laboratory tests as needed. Safety is closely monitored, and participants provide informed consent before enrollment. The trial aims to determine whether adjuvant chemotherapy improves survival compared to observation alone in this patient population.

This research aims to observe the safety and effectiveness of dabrafenib and trametinib in patients with BRAF V600E mutation-positive unresectable advanced or recurrent solid tumors, excluding colorectal cancer. It is a prospective, multicenter, single-arm, non-interventional observational study conducted through a central registration system using electronic data capture. The study includes both adult and pediatric patients, with long-term monitoring planned to collect comprehensive safety data. Patients already prescribed Tafinlar/Mekinist (dabrafenib and trametinib) before joining the study will be enrolled without treatment allocation or changes. The study targets 65 adult patients for effectiveness analysis and approximately 20 pediatric patients. Pediatric patients will be observed for up to 8 years after starting treatment to gather long-term information, while adult patients will be followed for one year post-treatment initiation. During participation, patient safety and treatment response will be monitored through reports of adverse events and overall response rates. Pediatric patients will have ongoing safety assessments related to skeletal and sexual development over the 8-year period. Adults will have their treatment response evaluated over one year. Data collection includes long-term follow-up regardless of treatment discontinuation, aiming to provide comprehensive post-marketing surveillance information on these medications.

This research investigates the safety of tisagenlecleucel (CTL019) that does not meet the usual commercial release standards, focusing on patients treated within the approved label by the Japan Health Authority. The study includes pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (pALL) and adults with relapsed or refractory large B-cell lymphoma (LBCL) and related types for Part 1. Part 2 includes patients with relapsed or refractory acute lymphoblastic leukemia and non-Hodgkin's lymphomas. The study is a Phase IIIb, open-label, multicenter trial assessing both safety and key efficacy for Part 1, with safety the main focus in Part 2. Participants receive a single intravenous infusion of CTL019, which consists of CAR-positive viable T cells. Part 1 participants are followed for 3 months after infusion, while Part 2 participants are followed for 1 day. Patients are included if their tisagenlecleucel batch does not meet commercial release standards but is individually approved by Novartis teams for safety. The study excludes those with certain infections, CNS lymphoma, hypersensitivity, or uncontrolled infections in Part 1, while Part 2 follows the product’s approved guidelines. During the study, participants undergo safety monitoring to record adverse events from screening through follow-up periods (3 months for Part 1 and 1 day for Part 2). Investigators carefully assess each patient's response and safety outcomes related to the tisagenlecleucel treatment. Informed consent is required before participation, and patients are observed for any side effects or reactions connected to the investigational infusion.

Researchers are evaluating treatments for patients with locally recurrent rectal cancer who have not previously received radiation. This phase III randomized trial in Japan started in August 2019 and aims to compare local relapse-free survival between two approaches: standard surgery plus adjuvant chemotherapy and preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy. The study plans to enroll 110 patients over six years from 43 institutions, focusing on whether adding chemoradiotherapy before surgery improves outcomes. Participants will be randomly assigned to one of two treatment groups. One group will undergo surgery followed by adjuvant chemotherapy using regimens such as CAPOX, mFOLFOX6, capecitabine, or 5-FU plus leucovorin. The other group will receive preoperative chemoradiotherapy consisting of capecitabine and radiation therapy before surgery, followed by adjuvant chemotherapy. Surgery will be performed within 42 days of registration for the surgery-first group, and between 56 and 98 days after completing chemoradiotherapy for the other group. Surgical procedures aim to achieve clear margins and may include various types of rectal and pelvic surgeries. Throughout the study, participants will be monitored for local relapse-free survival over three years as the primary outcome. Secondary outcomes include overall survival, relapse-free survival, rates of local and distant relapse, complete tumor removal rates, response to preoperative treatment, treatment completion rates, adverse events, and quality of life after surgery. Patients will undergo imaging tests, pathological assessments, and clinical evaluations to track disease status and treatment effects. The total study duration per participant includes treatment and follow-up assessments to measure long-term outcomes and safety.