Bankstown

Researchers are evaluating the combination of CGT9486 and sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors GIST. This Phase 3, open-label international trial involves multiple parts, including dose confirmation, drug interaction assessments, and efficacy comparisons. The study also includes substudies focusing on drug-drug interaction potential and first-line treatment in patients with specific genetic mutations KIT exon 9. Approximately 482 patients will participate across these parts.

Researchers are evaluating the safety, tolerability, and therapeutic effects of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first-line treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma HNSCC positive for human papilloma virus 16 HPV16 and expressing the protein PD-L1 with a combined positive score of 1 or higher. This is an open-label, multi-site, Phase IIIII clinical trial consisting of two parts an initial safety run-in phase and a randomized phase. In the safety run-in phase Part A, patients receive BNT113 in combination with pembrolizumab to confirm safety and tolerability at selected dose levels. The randomized phase Part B compares BNT113 combined with pembrolizumab against pembrolizumab monotherapy. Treatments are given by intravenous injection or infusion and continue for up to 24 months. An optional pre-screening phase allows tumor samples to be tested for HPV16 DNA and PD-L1 expression before the main trial screening. Participants will be closely monitored throughout the study. Assessments include safety evaluations, tumor response, and survival outcomes such as overall survival and progression-free survival. Tumor tissue samples must be provided for testing. Researchers will measure treatment-emergent adverse events, response rates, duration of response, and disease control. The study may last up to 48 months, with ongoing safety and efficacy monitoring during and after treatment.

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.

Heart attacks occur when a blood clot blocks the hearts blood vessels, stopping blood flow to the heart muscle. This trial focuses on patients with ST-elevation myocardial infarction STEMI and looks at how microcirculatory damage can be measured using the Index of Microcirculatory Resistance IMR. The study aims to find out if treating patients with impaired microcirculatory perfusion using low-dose intracoronary thrombolytic therapy can reduce heart muscle damage and improve clinical outcomes. Participants who have had a heart attack and undergone angioplasty will have their IMR measured. Those with an IMR above 32 will be randomly assigned to receive either low-dose tenecteplase a clot-dissolving drug or a placebo sterile water administered directly into the coronary artery. Patients with lower IMR will be followed in a registry. The treatment is given as an intracoronary infusion over 3 minutes. Cardiac enzymes, MRI scans, and other heart function tests will be done at various time points. During the study, participants will have heart enzyme tests at hospital admission and discharge. Those in the randomised group will receive cardiac MRI scans at discharge and six months later. Follow-up visits will occur at 30 days, then 6, 12, and 24 months after discharge to monitor heart function, rehospitalisation, and mortality. The main outcomes measured include cardiovascular death, heart failure rehospitalisation, heart attack size, and bleeding events, with safety and efficacy monitored closely throughout the study period.

Researchers are evaluating zipalertinib, an oral drug, for safety, effectiveness, and how it behaves in the body pharmacokinetics in adults with locally advanced or metastatic non-small cell lung cancer NSCLC that has specific mutations in the epidermal growth factor receptor EGFR, including exon 20 insertions and other uncommon mutations. This Phase 2b trial also studies how zipalertinib interacts with other drugs affecting liver enzymes and transporters and aims to find the best dose for treatment. Participants join one of four main groups based on their treatment history and mutation type those previously treated for exon 20 insertion mutations, those who are untreated but not candidates for standard chemotherapy, those with active brain metastases or leptomeningeal disease, and those with other uncommon EGFR mutations without prior systemic therapy. Two additional substudies focus on drug interactions using enzyme and transporter probe cocktails, and dose optimization with participants randomly assigned to two dosing arms. Zipalertinib is taken orally twice daily continuously until disease progression or other reasons to stop. During the study, participants undergo regular evaluations including scans to measure tumor response, brain imaging if applicable, laboratory tests, heart function monitoring, and assessments of side effects. Researchers track how long participants respond to treatment, disease control, survival, and changes in heart electrical activity. Safety and drug concentration in blood are closely monitored. Participants may remain in the study for up to approximately two years to assess these outcomes.

This research aims to compare the effects of oral anticoagulation versus no anticoagulation in patients aged 55 and older who have had recent episodes of transient atrial fibrillation triggered by stress and have additional factors that increase their risk of stroke. The study is a multinational, investigator-initiated, prospective, randomized, open-label trial evaluating the impact of non-vitamin K oral anticoagulants NOACs on preventing stroke and other serious cardiovascular events. Participants will be randomly assigned to either receive one of several NOACs, such as edoxaban, apixaban, dabigatran, or rivaroxaban, prescribed by their physician for the duration of the follow-up, or to a control group that will not receive anticoagulants unless medically indicated during the study. The choice of specific NOAC and dose adjustments are determined by the prescribing doctor. The study excludes patients with certain conditions like chronic atrial fibrillation, severe kidney or liver disease, recent cardiac surgery, or bleeding risks. During the study, participants will be monitored for up to 24 months to assess the occurrence of non-hemorrhagic stroke, systemic embolism, vascular mortality, myocardial infarction, peripheral arterial thrombosis, amputation, and venous thromboembolism. Regular follow-up will include evaluation of these outcomes to measure the effectiveness and safety of anticoagulation compared to no anticoagulation. Participants will provide informed consent and remain under medical supervision throughout the trial.

This research aims to evaluate treatments for patients who arrive at the emergency department with acute ischemic stroke caused by basilar artery occlusion within 24 hours of symptom onset. The study compares the use of tenecteplase, a clot-busting drug, against standard care which may include alteplase or no thrombolytic treatment, with the goal of improving functional outcomes at 90 days after stroke. It is a multi-arm, multi-stage, randomized trial designed to adaptively assess treatment effects and proceed seamlessly from phase 2b to phase 3 based on early results. Participants are randomly assigned to one of two groups one receiving intravenous tenecteplase at a dose of 0.25 mgkg given as a quick bolus, and the other receiving standard care that may include intravenous alteplase at 0.9 mgkg or no thrombolytic treatment. Both groups may undergo mechanical thrombectomy if deemed necessary by their treating doctors. The study uses a computer-based randomization process and will monitor patients through an adaptive sample size plan, with a minimum of 320 and up to 688 patients over about five years. During the trial, participants will be followed for 12 months. Researchers will assess stroke recovery using the modified Rankin Scale at 90 days as the primary outcome, along with other measures like quality of life, early clinical improvement, and safety outcomes such as bleeding in the brain. Assessments include angiography, brain imaging, and clinical evaluations at multiple time points. This ongoing monitoring will help determine which treatment offers better functional recovery and safety for stroke patients with basilar artery occlusion.

Researchers are evaluating the safety and effectiveness of gotistobart ONC-392BNT316, a next-generation anti-CTLA-4 antibody, in patients with metastatic non-small cell lung cancer NSCLC whose disease has progressed after treatment with anti-PD-1 or PD-L1 antibody-based therapies. This Phase 3 clinical trial aims to compare gotistobart with the chemotherapy drug docetaxel to see if it can help prolong life in these patients. Approximately 630 patients will participate, and the study is divided into two stages to confirm dosing and assess outcomes. In Stage I, two dosing regimens of gotistobart will be tested against docetaxel, which is given at 75 mgm2 every 21 days. Gotistobart will be administered by intravenous infusion over 60 minutes every 21 days, either at 3 mgkg or 6 mgkg with two loading doses of 10 mgkg. After selecting the most appropriate dosing regimen, Stage II will compare that gotistobart dose with docetaxel in patients with squamous cell NSCLC. Treatment will continue for up to 17 cycles, approximately one year. Participants will receive regular infusions and be monitored for overall survival over 36 months, along with secondary outcomes like tumor response, progression-free survival, and treatment-related adverse events. Patients must have measurable tumors and meet specific health criteria before joining. The study includes safety monitoring and ongoing assessments to evaluate how well the treatments are tolerated and their effects on cancer progression.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

Researchers are investigating the best treatment approaches for infections in artificial hip and knee joints. This study compares different surgical methods, antibiotic choices, and durations of antibiotic treatment to determine which combinations lead to the best outcomes and cure rates at 12 months. The trial focuses on adults with infected artificial joints and aims to address the significant health and economic impacts of prosthetic joint infections. Participants may receive one of several surgical strategies cleaning the infected joint without removing the implant DAIR, or revision surgery where the infected implant is replaced either in a single operation or two stages. Antibiotic treatments are also compared, with some participants receiving standard antibiotics alone and others receiving additional rifampicin. The study further explores different lengths of antibiotic courses after revision surgery, including shorter and longer durations and extended prophylaxis after two-stage revisions. During the study, participants consent to have their medical and treatment information collected in a central database and registry. Researchers will assess health status, infection cure, joint function, quality of life, and antibiotic use at 100 days and 12 months after starting the study. Outcomes like reinfection, survival, and revision surgeries will be monitored up to two years. This study does not require extra tests or treatments beyond routine care and follows participants closely to evaluate treatment success and safety.