Isehara

Researchers are conducting a master protocol study to evaluate the long-term safety and efficacy of the drug pirtobrutinib in patients who have completed previous clinical studies involving this medication. This study includes participants with chronic lymphocytic leukemia or non-Hodgkin lymphoma and aims to monitor their health over an extended period. The master protocol organizes individual study-specific appendices ISAs representing participants from earlier originator studies. Participants continue to receive pirtobrutinib as they did in their original clinical study, with the drug administered orally. The study allows these individuals to keep taking the treatment or to continue with follow-up visits under this master protocol framework. The study is designed to gather safety and survival data over many years. During the study, participants will be closely monitored for any serious treatment-related side effects, with assessments focused on adverse events occurring from the first dose until shortly after the last dose or when starting a new anticancer therapy. Researchers will also track overall survival for up to 93 months. This long-term follow-up ensures comprehensive safety and health evaluations throughout the participants involvement, which may last several years.

Researchers are evaluating Enzomenib DSP-5336, an oral drug, in patients with various types of acute leukemia, including relapsed or refractory acute myeloid leukemia AML, acute lymphocytic leukemia ALL, and acute leukemia of ambiguous lineage. The study also includes patients with high-risk myelodysplastic syndromes MDS and relapsed multiple myeloma MM in selected sites. This phase 12 trial aims to assess the safety, pharmacokinetics, pharmacodynamics, and clinical activity of DSP-5336 alone or combined with standard AML treatments, particularly in patients with specific genetic mutations like MLL rearrangement or NPM1 mutation. The study involves dose escalation and dose expansion of DSP-5336 administered orally. Participants may receive DSP-5336 alone or combined with standard AML regimens such as venetoclax plus azacitidine or intensive chemotherapy with cytarabine and daunorubicin 73. Different study arms include patients with or without certain medications like CYP3A4 inhibitor azoles, and those with specific genetic profiles. The trial evaluates recommended phase 2 doses for various patient groups and combination treatments. Participants will undergo assessments including monitoring for adverse events within 30 days after the last dose and evaluation of clinical responses approximately six months after treatment begins. Researchers will collect blood and bone marrow samples for genomic analysis and track drug levels in the body. Safety labs, ECGs, physical exams, and patient questionnaires will be performed throughout the study. The trial includes long-term follow-up of overall survival up to two years after treatment ends, with visits and tests scheduled to monitor health and treatment effects.

Researchers are evaluating the tolerability and safety of a drug called ONO-4685 when given alone to patients with relapsed or refractory T Cell Lymphoma and Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma CLLSLL. This is an open-label Phase I trial designed to identify potential side effects and appropriate dosing in these patient groups where standard therapies may no longer work or are unavailable. ONO-4685 is administered through intravenous infusion and will be given repeatedly until the disease progresses or unacceptable side effects occur. The study does not include a control group and focuses solely on the effects of ONO-4685 in these patients. The trial includes a dose escalation phase to find the best tolerated dose. Participants will be closely monitored for safety and effectiveness for about one year. This includes tracking any dose-limiting toxicities, adverse events, and changes in vital signs like body temperature, pulse, and blood pressure. Laboratory tests, chest X-rays, and ECGs will be performed regularly. Researchers will also assess tumor response, survival outcomes, and various pharmacokinetic measures during the study period.

Researchers are evaluating the effectiveness and safety of CLS2901C human allogenic chondrocyte sheets combined with proximal tibial osteotomy compared to osteotomy alone in patients with osteoarthritis of the knee OAK. This phase III study focuses on patients aged 20 to 79 years diagnosed with OAK, classified by specific X-ray criteria. The purpose is to understand how this new cellular therapy may impact knee function and symptoms over time. The study involves two groups one receiving osteotomy surgery alone and the other receiving osteotomy combined with CLS2901C chondrocyte sheets applied to the knee. The chondrocyte sheets are made by culturing cartilage cells derived from patients with polydactyly. The evaluation period for each group lasts about 14.5 months, including 52 weeks of active assessment followed by up to 5 years of additional observation for those available to continue. Participants will undergo various assessments including knee function measured by the KOOS 4 score over 52 weeks. Safety is monitored through adverse event rates and product malfunctions. Researchers will also continue to observe patients for up to 5 years after receiving the chondrocyte sheets to evaluate long-term effects. The overall study duration spans from initial treatment through extended follow-up to fully understand treatment outcomes and safety.

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan Dato-DXd with or without Durvalumab compared to investigators choice chemotherapy combined with Pembrolizumab in patients with PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer TNBC. This Phase III, randomized, open-label, international study aims to determine if Dato-DXd with Durvalumab can improve progression-free survival and overall survival while assessing quality of life impacts in this patient population. Participants are assigned to one of three groups Dato-DXd with Durvalumab, investigators choice chemotherapy paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin combined with Pembrolizumab, or Dato-DXd alone. All study drugs are given by intravenous infusion. The study includes stratification by geographic region, disease-free interval, and prior PD-1PD-L1 treatment. Treatment continues with monitoring up to about 33 months for progression-free survival and safety, with some outcomes followed up to 64 months. Throughout the study, participants undergo assessments including imaging to measure tumor response using RECIST criteria, laboratory tests, and questionnaires to evaluate symptoms and quality of life. Researchers monitor time to disease progression, overall survival, response duration, and safety outcomes. Follow-up includes evaluation of subsequent therapies and pharmacokinetics. The total participation duration can be up to several years to capture long-term outcomes.

This research aims to evaluate the effectiveness and safety of zanidatamab combined with a physicians choice of chemotherapy compared to trastuzumab combined with chemotherapy in treating adults with metastatic HER2-positive breast cancer who have either progressed on or cannot tolerate previous trastuzumab deruxtecan T-DXd treatment. Zanidatamab has shown promising results against various HER2-positive advanced tumors, including metastatic breast cancer, and may serve as a potential treatment option for these patients. The study also investigates patient-reported tolerability and physical functioning, as well as the pharmacokinetics and immune response to zanidatamab with chemotherapy. Participants will be randomly assigned to receive either zanidatamab or trastuzumab, each given by intravenous infusion alongside one of several chemotherapy options chosen by the physician eribulin, vinorelbine, gemcitabine, or capecitabine the latter is taken orally. Treatment will be administered according to the assigned group, and the study is open-label and multicenter, designed to compare these two treatment combinations in this patient population. During the study, participants will undergo regular assessments to monitor disease progression using imaging criteria RECIST version 1.1, evaluate survival, treatment response, and duration of response. Safety and side effects will be tracked through adverse event reporting and patient questionnaires on symptoms and physical function. Blood samples will be collected to study drug levels and immune reactions. Participants will be followed until disease progression, death, or for up to approximately 44 months for key outcomes, with overall survival monitored for up to about 80 months.

This research aims to assess the long-term safety and effectiveness of pirtobrutinib in people who have previously been treated for Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma. It is a Phase 4 study involving participants who completed an earlier study called LOXO-BTK-18001. The study invites these participants to continue their assigned treatment or follow-up in this extension study. Participants will continue receiving pirtobrutinib, which is taken orally, as they did in the original study. This study serves as an individual-study appendix under the master protocol J2N-MC-JZNY. There are no new treatment groups participants maintain the therapy they were assigned before. During the study, participants will be monitored for serious treatment-related side effects, including tracking any grade 3 or higher adverse events occurring from the first dose through 30 days after the last dose or until starting a new cancer therapy. Researchers will also observe overall survival up to 93 months from enrollment in the original study. Participants will have regular follow-up visits to assess their health and treatment safety over the long term.

Researchers are evaluating how well brenipatide LY3537031 is tolerated, its side effects, and its safety and effectiveness in adults with Irritable Bowel Syndrome-Constipation IBS-C. This Phase 2 study compares brenipatide given under the skin with a placebo to better understand its impact on IBS-C symptoms. The trial is sponsored by Eli Lilly and Company and lasts about 35 weeks. Participants will receive either brenipatide or a placebo, both administered subcutaneously. The study uses a randomized, double-blind, placebo-controlled design with parallel groups. Treatment effects will be measured primarily between weeks 9 and 16, focusing on the weekly composite clinical response. Secondary outcomes include abdominal pain and bowel movement responses during the same period. During the study, participants will be monitored for safety and symptom changes. They will record abdominal pain scores daily and bowel habits using a stool form scale. Researchers will review these data along with other health assessments to evaluate the study drugs effects. The total participation duration is approximately 35 weeks, including screening, treatment, and follow-up periods.

Researchers are evaluating the safety, side effects, and effectiveness of brenipatide LY3537031 in adults with Irritable Bowel Syndrome-Diarrhea IBS-D. The study compares brenipatide administered under the skin with a placebo to understand its impact on this condition. This Phase 2 clinical trial involves participants aged 18 to 75 years. Participants will receive either the study drug brenipatide or a placebo through subcutaneous injections. The study follows a randomized, double-blind design where neither participants nor researchers know which treatment is given. Treatment and placebo administrations occur during the trial, which lasts approximately 35 weeks. During the study, participants will be monitored for how well they tolerate the drug and any side effects. Researchers will collect daily data on abdominal pain and stool consistency using an eDiary, focusing on responses between weeks 9 and 24. The primary measure is the percentage of participants achieving a daily composite response for at least half the days between weeks 9 and 16. Safety and efficacy outcomes are tracked throughout the trial period.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.