Norwalk

Researchers are investigating whether buntanetap/Posiphen can help treat early Alzheimer's disease in adults aged 55 to 85 years. This Phase 3 study aims to find out if buntanetap/Posiphen improves thinking abilities and daily functioning compared to a placebo. It also evaluates the safety of buntanetap/Posiphen by monitoring any medical issues that participants may experience during the trial. Participants will take either a 30 mg capsule of buntanetap/Posiphen or a placebo capsule by mouth once daily for 18 months. The study includes regular clinic visits at screening, enrollment, and months 1, 3, 6, 9, 12, 15, and 18. During some visits, participants will have brain MRI scans. The study uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo. Throughout the study, participants will complete tests and questionnaires to measure cognitive function and daily living activities, including the ADAS-Cog13 and ADCS-iADL scales. Phone calls before and after visits help track progress and adherence. Safety is closely monitored with ongoing assessments from screening through the 18-month treatment period.

This research aims to collect long-term safety and effectiveness data for participants treated with ibrutinib, a medicine used for various blood cancers and conditions including Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Waldenstrom Macroglobulinemia, and Chronic Graft Versus Host Disease. It also provides ongoing access to ibrutinib for participants who have completed previous ibrutinib studies, continue treatment, and benefit from it. This is an open-label Phase 3b study without formal hypothesis testing. Participants will continue their current ibrutinib dosing regimen from the prior study, taken orally once daily as capsules in doses of 560 mg, 420 mg, 280 mg, or 140 mg, around the same time each day. Treatment continues until the investigator decides the participant no longer benefits due to disease progression or side effects, the participant withdraws, alternative ibrutinib access becomes available, or the study ends. Participants not able to access ibrutinib elsewhere can keep receiving the single-agent ibrutinib until all transition or stop treatment, or until the study is stopped. During the study, safety is monitored throughout and summarized, and effectiveness may be analyzed together with previous study data. The main outcome measured is the number of participants experiencing any adverse events within 30 days after the last dose or until starting another cancer treatment. Participants will undergo assessments including pregnancy testing and investigator evaluations to ensure ongoing benefit and safety. The study duration depends on when participants stop treatment or transition to other access.

This research aims to screen and detect early stage pancreatic cancer and precursor lesions in individuals who have a strong family history or genetic predisposition to pancreatic cancer. It focuses on people aged 50 to 90 years who carry certain high-risk gene mutations or have multiple relatives diagnosed with pancreatic cancer. The study seeks to improve early detection methods to better identify pancreatic cancer at a treatable stage. Participants will undergo annual Magnetic Resonance Imaging and Magnetic Cholangiopancreatography (MRI/MRCP) scans with IV gadolinium contrast and high-resolution imaging of the pancreas over a period of three years, totaling four MRI scans. Blood samples will be collected every six months for three years to create a bio-bank that supports the development of a blood-based screening test. Any abnormalities found on MRI will be reviewed by a specialist tumor board and discussed with the participant. The study covers the costs of MRI scans. During the study, participants will complete a five-minute psychological survey and provide blood samples biannually. Researchers will monitor for early stage pancreatic cancer or precursor lesions through imaging and blood analysis, tracking results for up to three years. Participants are expected to return to the study site for all assessments. The study includes safety evaluations related to MRI and gadolinium contrast and follows participants closely to understand the development of pancreatic cancer in high-risk individuals.

Researchers are exploring how new-onset or worsening diabetes may be linked to early pancreatic cancer or its precursors. This study focuses on individuals aged 50 and older who have recently developed diabetes or whose diabetes is getting worse. The goal is to better understand this relationship and to help develop a blood test that could screen for pancreatic cancer earlier. Participants will have an MRI/MRCP scan with contrast at the start of the study to look for early signs of pancreatic cancer. If the MRI shows any abnormalities, a team of experts will review the results and discuss them with the participant. Additional imaging may be done if recommended. Every six months for up to three years, participants will provide blood samples and complete a brief psychological survey, contributing to a bio-bank for future research. Throughout the study, participants will be regularly monitored with scans and blood tests to track any changes. The main outcome being measured is the detection of early stage pancreatic cancer or precursor lesions over the three-year study period. Participants need to be willing to undergo MRI scans, give blood samples, and attend scheduled visits at the study site.

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who have agitation related to Alzheimer's Disease. This phase 3 study aims to better understand how these treatments impact agitation symptoms in this population by comparing them to a placebo group. Participants must have a confirmed Alzheimer's diagnosis and meet specific criteria for agitation severity to join the study. Participants will receive either the Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, or a placebo, each given at specified doses on designated days. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison of treatment effects. The treatment period lasts through Week 14, during which dosing schedules are closely followed. Throughout the study, participants will be regularly assessed using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) to measure changes in agitation levels from baseline to Week 14. Caregivers will provide reports on participant status and help ensure medication compliance. Safety and symptom changes will be carefully monitored to evaluate the treatments' effects during this period.

Researchers are evaluating the maximum tolerated dose and safety of Anvumetostat, a PRMT5 inhibitor, given in combination with other therapies for adults with metastatic or locally advanced gastrointestinal, biliary tract, or pancreatic cancers that have a specific genetic deletion called homozygous MTAP-deletion. This phase 1b study aims to find the recommended dose while monitoring safety and tolerability in these patients. Participants will receive Anvumetostat orally along with other treatments including gemcitabine and nab-paclitaxel given intravenously, modified FOLFIRINOX (a combination of irinotecan, 5-FU, leucovorin, and oxaliplatin given IV), or RMC-6236 taken orally. The study includes different subprotocols for patients based on their cancer characteristics and previous treatments. Treatment schedules and combinations are carefully evaluated to determine the best dosing. During the study, participants will be closely monitored for side effects such as dose limiting toxicities, treatment emergent adverse events, and serious adverse events for up to about two years. Researchers will assess organ function, tumor response using RECIST criteria, and overall safety. The study involves tumor biopsies or archival tissue samples and various clinical assessments throughout the treatment and follow-up periods to ensure comprehensive evaluation of the drug combinations.

Researchers are evaluating a combination of disitamab vedotin and tucatinib for treating patients with advanced or metastatic breast cancer or gastric cancer that express the HER2 protein. These solid tumors, which arise in organs like the breast or stomach, are challenging to treat once they have spread or grown larger. The trial focuses on patients whose tumors have HER2, a marker that can make the cancer grow and spread faster. The study aims to assess the safety and effectiveness of this drug combination in these cancers. The study includes a dose escalation phase where disitamab vedotin is given intravenously while tucatinib is taken orally twice daily at 300 mg. After determining two appropriate dose levels, the study proceeds to a dose optimization phase to evaluate safety and efficacy in different patient groups based on HER2 expression and cancer type. Following this, an expansion phase will test the treatment in four specific cohorts, including HER2-low and HER2-positive breast and gastric cancers. Participants will have regular assessments including monitoring for side effects, laboratory tests, and scans to evaluate tumor response using RECIST criteria. Safety will be followed for up to approximately five years after the last treatment dose. Key outcomes measured include the number of participants experiencing dose-limiting toxicities, adverse events, laboratory abnormalities, and dose changes. The study also tracks the objective response rate to the treatment over about three years.

Researchers are evaluating the safety and effects of a medicine called Mevrometostat for treating adults with Relapsed/Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC), and Follicular Lymphoma (FL). This Phase 1 study includes three parts; Parts 1 and 2 have finished enrolling, while Part 3 is currently open and focuses on men with CRPC who have progressed after prior treatment. The study aims to understand the safety profile, toxicities, and preliminary effectiveness of Mevrometostat alone or combined with other treatments. Participants in Part 3 receive oral Mevrometostat and/or enzalutamide. Part 3 has two substudies: a Bioequivalence (BE) substudy where participants take three single doses of Mevrometostat in separate periods, and a Drug-Drug Interaction (DDI) substudy with two cohorts. Cohort 1 receives Mevrometostat twice daily and/or itraconazole once daily, while Cohort 2 receives Mevrometostat twice daily, enzalutamide once daily, and/or itraconazole once daily. After the assessment phase, all participants enter a maintenance phase taking Mevrometostat twice daily and enzalutamide once daily until their cancer no longer responds. Throughout the study, participants will have regular evaluations including monitoring for dose limiting toxicities, adverse events, laboratory abnormalities, vital signs, and disease response. The study will track radiographic progression-free survival until disease progression or death, up to approximately two years. This close monitoring aims to gather data on the safety, tolerability, and effects of the treatments over time.

Researchers are evaluating the safety and effectiveness of neoadjuvant carboplatin combined with mirvetuximab soravtansine in adult women with folate receptor alpha (FRα)-expressing advanced-stage serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. This is a single-arm Phase 2 study involving about 140 participants across approximately 80 sites in the United States. The study focuses on advanced disease stages III and IV, with FRα expression confirmed in tumor cells. Participants will receive intravenous infusions of mirvetuximab soravtansine together with carboplatin on day 1 of each 21-day cycle, continuing for up to 6 to 9 cycles. Bevacizumab may also be given as an intravenous infusion if the investigator decides it is appropriate. The total duration of the study is about 3 years, during which treatments and responses will be closely monitored. During the study, participants will attend regular visits at hospitals or clinics for medical evaluations including blood tests, scans, and safety assessments. Researchers will track tumor response using independent central review over the course of up to 3 years. The study involves frequent medical monitoring to assess treatment effects and participant safety.

Researchers are evaluating the effectiveness and safety of plixorafenib, an oral drug, in people aged 10 years and older who have various types of cancers with specific BRAF genetic changes. These include locally advanced or metastatic solid tumors, primary central nervous system (CNS) tumors with BRAF fusions, and rare BRAF V600-mutated tumors such as melanoma, thyroid cancer, and recurrent CNS tumors. The study is a Phase 2 Master Protocol designed to assess this targeted therapy in multiple subgroups based on tumor type and genetic profile. Participants receive plixorafenib oral tablets, and the study includes several subprotocols tailored to different tumor types and BRAF alterations. Subprotocols A, B, and C focus on tumors with BRAF fusions or rare BRAF mutations, while Subprotocol D enrolls adults aged 18 to 65 with solid tumors harboring BRAF V600E mutations not eligible for other subprotocols. Before starting treatment, participants provide tumor tissue or blood samples for genetic testing and scans to monitor tumor changes. Some subprotocols require stable or decreasing corticosteroid doses before treatment. Throughout the study, participants undergo regular evaluations including imaging scans, biopsies, and laboratory tests to assess tumor response and drug levels. The main outcomes measured are the objective response rate for most subprotocols and pharmacokinetics for Subprotocol D, with follow-up lasting up to approximately four years. Safety monitoring includes tracking adverse events and ensuring recovery from prior treatments, with additional assessments for heart function and infection status as needed.