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This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the safety, tolerance, and effects of elritercept, alone and combined with the JAK inhibitor ruxolitinib, in adults with myelofibrosis (MF). This Phase 2 study aims to learn how elritercept impacts the signs and symptoms of MF, how the body processes the drug, and its effects on anemia and blood cell counts. Elritercept is an investigational protein designed to boost red blood cell and platelet production by blocking certain signals that suppress blood formation. Participants receive elritercept as a subcutaneous injection either alone or in combination with oral ruxolitinib tablets. The study includes different groups based on prior treatments: those previously treated with JAK inhibitors and those currently on ruxolitinib with insufficient disease control or side effects limiting dose. A specific group in Brazil includes participants with no prior JAK inhibitor treatment. The study monitors participants over about 8 years, including long-term extension periods. During the study, participants will be regularly assessed for side effects, blood cell levels, and overall health. Researchers will track adverse events and serious side effects from informed consent through 30 days after the last dose. Other evaluations include laboratory tests, symptom assessments, and pharmacokinetic analyses to understand how elritercept behaves in the body. Participants agree to follow all study procedures and return for follow-up visits throughout the study period.

Researchers are evaluating the safety and tolerance of elritercept, a recombinant fusion protein, in adults with anemia linked to lower-risk myelodysplastic syndromes (MDS). The study aims to understand how elritercept affects red blood cell production and to monitor participants for any worsening of MDS during treatment. This is a Phase 2, open-label study focused on patients with very low, low, or intermediate risk MDS. Participants receive elritercept through subcutaneous injections at different dose levels to assess safety and effects. The study includes multiple parts, with initial treatment cycles followed by an extension phase for those who complete the first part without dose-limiting toxicities and may benefit from continued treatment. The study also includes several cohorts based on specific MDS characteristics and transfusion needs. During the study, participants undergo regular evaluations including blood tests, bone marrow assessments, and monitoring for adverse events. Researchers will track the number of treatment-emergent and serious adverse events for up to 11.2 years. Participants are closely monitored for how well they tolerate elritercept and its impact on anemia and red blood cell production throughout the study duration.

Researchers are evaluating whether accelerated BEP chemotherapy is more effective than the standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumors. This phase 3 trial focuses on patients with these tumor types, aiming to improve cure rates beyond those achieved with current treatments. The trial is led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group and addresses the need for better first-line treatments due to limited success and higher toxicity of previous strategies. The study compares two treatment regimens: standard BEP chemotherapy given every 3 weeks for 4 cycles and accelerated BEP chemotherapy given every 2 weeks for 4 cycles. Both regimens include Bleomycin, Etoposide, and Cisplatin administered intravenously at specified doses, plus supportive treatments with Pegylated G-CSF (Pegfilgrastim) and Filgrastim to help manage blood cell counts. The accelerated arm includes additional weekly doses of Bleomycin after the initial 4 cycles. These regimens are designed to test if faster cycling of chemotherapy drugs improves outcomes. Participants will be closely monitored from the time of randomization through up to 5 years for progression-free survival, which measures time until disease progression or death. Assessments include laboratory tests to check bone marrow, liver, and kidney function, as well as evaluations of overall health status. Participants must be able to start treatment within 14 days of randomization and comply with all study procedures. Safety and effectiveness of the treatments will be tracked throughout the study duration to determine if the accelerated regimen offers improved results.

Researchers are working on the ETHOS II Project to improve care for people with hepatitis C virus (HCV) in drug treatment clinics and needle and syringe programs (NSPs) across New South Wales and Australia. The project aims to create a framework for better HCV screening and treatment services in these settings nationally. It is a collaborative effort involving multiple health and research organizations, focusing on individuals with a history of injecting drug use or those receiving opioid substitution therapy. The study involves an intervention that includes on-site HCV RNA testing, liver fibrosis assessment, and helping participants connect to care to increase the use of direct-acting antiviral therapy for HCV. Participants will undergo procedures such as Hepatitis C testing, fibroscan, questionnaires, and clinical assessments during "campaign days." A sub-study will invite 550 participants to provide blood samples to evaluate new diagnostic tests for chronic HCV infection. The project also includes interviews with policy makers, clinicians, and patients to understand challenges in HCV care, and the development of an education and training program to improve workforce skills and HCV care quality. Participants will be recruited from drug treatment clinics, general practices, and NSP programs. They will complete surveys and may consent to link their data with health databases for ongoing study. The main outcome measured is the number of participants starting anti-HCV treatment each year for up to three years. Researchers will monitor participant health records and follow up through medical record reviews, ensuring thorough tracking of treatment initiation and care engagement throughout the study duration.

Researchers are evaluating the effect of adding SBP-101 to the standard treatment of gemcitabine and nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma who have not received prior treatment for metastatic disease. This randomized, double-blind, placebo-controlled, multicenter study aims to assess overall survival as the primary endpoint, with secondary goals including progression-free survival, radiologic response, and quality of life. The study includes approximately 600 participants and is conducted in phase 2 and phase 3 stages. Participants will be randomly assigned to receive either SBP-101 with gemcitabine and nab-paclitaxel or a placebo with gemcitabine and nab-paclitaxel. SBP-101 is given as a subcutaneous injection and is studied in combination with the chemotherapy drugs nab-paclitaxel and gemcitabine. The study also incorporates a Data Safety Monitoring Board to oversee safety, efficacy, and a planned analysis to determine if the study should continue. During the study, participants will undergo assessments including imaging scans to measure tumor response, quality of life evaluations, and safety monitoring. Overall survival will be tracked from the first dose for up to 100 weeks or until death. The study ensures participants meet specific health and laboratory criteria before enrollment and requires ongoing monitoring to evaluate treatment effects and safety throughout the trial.