Traralgon

Researchers are studying pirtobrutinib, an oral drug, to understand how well it works and how safe it is for people with chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. The study focuses on participants who have previously received 1 to 3 treatments, including a covalent Bruton tyrosine kinase BTK inhibitor, as well as those with treatment-nafve CLLSLL who have a specific genetic change called 17p deletion. This is a Phase 2 open-label trial sponsored by Loxo Oncology, Inc. The study has two parts. Part 1 tests three different dose levels of pirtobrutinib in participants with relapsed or refractory CLLSLL who have prior treatment experience, lasting about 3 years. Part 2 evaluates pirtobrutinib alone in participants who have not received prior treatment but have the 17p deletion, with participation lasting up to 2 years. All doses are given orally. Participants will take the study drug orally and attend visits for up to 3 years in Part 1 or up to 2 years in Part 2. Researchers will monitor how well the disease responds to treatment using overall response rate and how long the response lasts. Safety will be tracked throughout. Participants ability to swallow oral medication and their overall health status will be assessed before and during the study to ensure suitability and safety.

Researchers are evaluating the combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.

This trial is focused on adults with cancer who are receiving chemotherapy and experience nausea and vomiting as side effects. Researchers are studying a drug called LY3537021 to see how well it controls these symptoms and to evaluate its safety. The study is a Phase 2, double-blind, placebo-controlled trial designed to better understand the treatment options for chemotherapy-induced nausea and vomiting in this population. Participants are randomly assigned to receive either LY3537021 or a placebo, both given as a subcutaneous injection before chemotherapy. All participants also receive standard anti-nausea treatments, which may be taken orally, intravenously, or through skin patches. The chemotherapy drugs involved include cisplatin or an anthracycline and cyclophosphamide combination. The study treatment is given prior to chemotherapy, and the trial lasts about two months per participant. During the study, participants will be monitored for nausea and vomiting from the time of their chemotherapy infusion through up to five days afterward. Researchers will collect data on symptom control, the need for rescue medications, and drug levels in the body. Participants will complete diaries to track nausea severity. Safety and response to treatment are carefully observed. The study aims to measure how many participants have a complete response to nausea and vomiting during the delayed phase after chemotherapy.

Researchers are conducting a three-part Phase 3 clinical trial to evaluate a potential new medicine called Sofetabart Mipitecan Sofe-M in people with high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancers. The study focuses on patients with platinum-resistant cancer in Part A, meaning their disease worsened during or within six months of platinum-based chemotherapy, and platinum-sensitive cancer in Parts B and C, where disease remained controlled for more than six months after platinum treatment. The goal is to assess whether Sofe-M works better than current standard treatments and to understand its safety. Participants receive treatments administered intravenously. Part A compares Sofe-M to investigators choice of chemotherapy or Mirvetuximab Soravtansine MIRV. Parts B and C compare Sofe-M plus bevacizumab to platinum-based doublet chemotherapy plus bevacizumab. The study includes multiple chemotherapy options such as paclitaxel, topotecan, gemcitabine, and pegylated liposomal doxorubicin. Each participants involvement duration depends on their response to treatment. During the trial, participants undergo regular assessments including imaging to measure progression-free survival and overall survival. Researchers also track tumor marker responses, side effects, quality of life scores, and pharmacokinetics of Sofe-M. The study uses a randomized design without masking. Follow-up can last up to about 70 months, allowing for long-term safety and effectiveness monitoring.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

This trial investigates whether fluid therapy with Plasma-Lyte48 increases the number of days alive and out of hospital by day 28 compared to 0.9% sodium chloride saline in critically ill patients with moderate to severe diabetic ketoacidosis DKA admitted to emergency departments and critical care units. DKA is a serious complication of diabetes, and hospital admissions for this condition have risen notably in recent years. Current treatment guidelines rely on limited evidence, creating a need for clearer information on the best fluid therapy approach. Participants receive either Plasma-Lyte48 or 0.9% saline as intravenous fluids for resuscitation during two 12-month periods across 20 hospitals, with a one-month break between periods. Each hospital switches fluids after the first period. The fluids are blinded and provided by Baxter Healthcare, with treatments continuing until discharge from critical care or up to 72 hours. Additional therapies, including glucose solutions and electrolyte supplements, are used as needed based on clinical judgment. During the study, patients are monitored for hospital-free days up to 28 days after enrollment, with telephone follow-up to collect information. Secondary outcomes include ICU-free days, readmissions, kidney function, mental status changes, ketosis resolution time, insulin use, and potassium replacement. The study involves consumer representatives and aims to provide evidence to improve DKA management. Total participation involves treatment and follow-up over 28 days post-enrollment.

Researchers are evaluating lunsekimig, a subcutaneous injection, compared with placebo in adults aged 40 to 80 years with inadequately controlled Chronic Obstructive Pulmonary Disease COPD characterized by an eosinophilic phenotype. This Phase 2bPhase 3 parallel study aims to assess the efficacy, safety, and tolerability of lunsekimig in reducing COPD exacerbations and improving lung function and symptoms. Participants are randomly assigned to one of three groups lunsekimig dose regimen A, lunsekimig dose regimen B, or a matching placebo. They will receive subcutaneous injections during a 48-week treatment period. The study also includes a screening period of up to 4 weeks before treatment and an approximately 8-week follow-up period after treatment, totaling up to 60 weeks of participation. During the study, participants will undergo regular assessments including lung function tests such as post- and pre-bronchodilator Forced Expiratory Volume in 1 second FEV1, questionnaires measuring respiratory health and symptoms, and monitoring of COPD exacerbations. Safety will be evaluated through reported adverse events and laboratory tests. Researchers will also monitor blood levels of lunsekimig and the presence of antidrug antibodies. Participants will be followed closely throughout the study duration to assess treatment impact and safety.

Researchers are evaluating the long-term effects of lidocaine infusions given during and after surgery to reduce moderate or severe chronic post-surgical pain in adult women undergoing elective breast cancer surgery. This large, international, randomized, double-blind trial aims to detect a meaningful reduction in chronic pain one year after surgery and also assesses safety, pain relief, opioid use, nerve-related pain symptoms, psychological health, and quality of life. Participants receive either a lidocaine infusion starting with an intravenous bolus after anesthesia induction, continuing with an intraoperative intravenous infusion, and followed by a post-operative subcutaneous infusion for up to 24 hours. The lidocaine dosing is adjusted by lean body weight with a cap, while the comparison group receives a saline placebo infusion following the same schedule. Day-case surgeries receive only the intraoperative treatments without the post-operative infusion. During the trial, participants will be monitored for pain severity, opioid consumption, nerve-related symptoms, psychological distress, physical functioning, quality of life, safety events, and health care costs up to one year after surgery. The primary outcome is the incidence of moderate or severe chronic post-surgical pain reported at one year. Assessments include patient-reported outcomes, pain scores at 24 hours postoperatively, and opioid use at various timepoints. The total participation duration extends up to one year after surgery.

This research aims to evaluate the effects of lowering blood phosphate levels in adults with end-stage kidney disease ESKD who are receiving dialysis. Elevated phosphate levels are common in ESKD and linked to higher risk of death and heart problems, but it is unclear if reducing phosphate improves important patient outcomes. The study will compare intensive lowering of phosphate to a more liberal phosphate target to see if this reduces heart-related deaths and events, improves physical health, and is cost-effective. Participants will be randomly assigned to one of two groups one aiming for a liberal serum phosphate target of 2.0 to 2.5 mmolL, and the other aiming for an intensive target of 1.50 mmolL or lower. Doctors will decide the type and dose of phosphate-lowering medications to help participants reach their assigned phosphate levels, following usual local practices. The study will last up to five years and is conducted internationally with 3600 adults on dialysis. During the study, researchers will monitor participants for major heart-related events and deaths, physical health, fatigue, quality of life, patient satisfaction, and itching. Regular assessments will include measuring time to cardiovascular death or major cardiovascular events and evaluating overall survival and quality of life using the EQ5D-5L tool. The study will also assess cost-effectiveness and continue to observe participants for five years to collect comprehensive data on these outcomes.

This research aims to evaluate the omission of adjuvant whole breast radiation therapy in women with breast cancer who have no clinical evidence of lymph node involvement and have achieved a pathological complete response after neoadjuvant chemotherapy. The study focuses on female patients with newly diagnosed T1-3 node negative breast cancer treated with breast conserving surgery and axillary staging surgery, without distant metastatic disease. The goal is to understand the impact of skipping radiation therapy on breast cancer outcomes. Participants will not receive the usual adjuvant whole breast radiation therapy following breast conserving surgery. Instead, they will be followed over time to monitor their health status. The study is designed as a single arm cohort, meaning all enrolled women who meet the criteria will be observed without receiving radiation therapy. The first analysis is planned after a median follow-up of 5 years. Throughout the study, participants will undergo regular assessments to check for local, regional, and distant recurrence of breast cancer, as well as disease-free survival and overall survival. Any additional breast cancer treatments received after recurrence, such as repeat surgery, systemic therapy, or radiation, will be documented. The total participation duration is planned to extend up to 5 years, with ongoing monitoring to measure outcomes and safety.