Wahroonga

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 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 whether combining pasritamig with docetaxel can extend the time before prostate cancer worsens, compared to docetaxel alone. This study focuses on participants with metastatic castration-resistant prostate cancer, a form of prostate cancer that continues to grow despite low male hormone levels. The trial is a Phase 3, randomized, open-label study assessing radiographic progression-free survival as the main outcome. Participants in this study receive pasritamig, a T-cell-redirecting agent targeting human kallikrein 2, along with docetaxel, a chemotherapy drug. Prednisone is also administered as part of the treatment. The study compares this combination therapy against docetaxel alone to determine if the addition of pasritamig can improve outcomes. During the study, participants undergo regular scans to monitor cancer progression and other assessments to evaluate their health status. Researchers track how long participants live without the cancer worsening based on imaging results. The study includes ongoing monitoring of treatment effects and safety, lasting up to nearly two years to observe radiographic progression-free survival.

Researchers are evaluating the effectiveness and safety of the drug BMS-986365 compared to the investigator's choice of therapy in men with metastatic castration-resistant prostate cancer. This Phase 3 study aims to measure the length of time participants live without radiographic disease progression, using established criteria for bone and soft tissue cancer progression. The study focuses on patients who have already been treated with androgen receptor pathway inhibitors and have metastatic prostate cancer confirmed by imaging. Participants will be randomly assigned to receive either one of two dose levels of BMS-986365 or the investigator's choice of treatment, which may include Docetaxel plus Prednisone/Prednisolone, Abiraterone plus Prednisone/Prednisolone, or Enzalutamide. The study has two parts: initially, participants are assigned to one of three groups including two BMS-986365 doses or comparator therapy, followed by a second part where they are randomized to either the selected BMS-986365 dose or the comparator treatment. During the study, participants will be monitored for disease progression through scans and evaluations using Response Evaluation Criteria in Solid Tumors and Prostate Cancer Clinical Trials Working Group criteria, with follow-up lasting up to four years. Safety and treatment effects will be assessed regularly, and participants' symptoms and quality of life will be closely observed. This long-term follow-up helps researchers understand the treatment's impact on cancer progression and patient well-being.

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 evaluating the safety and potential benefits of the Akyva System, an implantable device designed to electrically stimulate the bladder muscle to help with urination in people who have underactive bladder and experience difficulty emptying their bladder. The study aims to see if this device can reduce the need for catheter use and improve the amount of urine left in the bladder after urinating. Participants in the study are adults with symptoms related to underactive bladder who have been using intermittent catheterization and have certain clinical measures that indicate bladder muscle weakness. The study involves implanting the Akyva System device, which directly stimulates the bladder wall muscle to promote bladder emptying. This is an open-label trial where all participants receive the device implant. The treatment period lasts 18 months, during which the device's safety and functioning are monitored. There are no placebo or comparison groups; instead, the focus is on observing the device's effects over this time. Participants will undergo various assessments before and after implantation, including clinical evaluations, bladder function tests, and monitoring of urinary symptoms and catheter use. Researchers will track the safety of the implantation procedure and device use throughout the 18-month treatment. The main outcome measured is the device's safety from enrollment until the end of treatment. Participants must be able to attend follow-up visits and comply with study procedures during this period.

Researchers are evaluating VIA Disc NP, a minimally processed human nucleus pulposus tissue allograft, as a supplement for degenerated intervertebral discs in participants with symptomatic lumbar disc degeneration lasting more than 6 months and unresponsive to at least 3 months of conservative treatment. This Phase 2 randomized, double-blind, sham-controlled, multi-center study aims to assess the safety and effectiveness of VIA Disc NP compared to a sham procedure. Participants will be randomly assigned in a 1:1 ratio to receive either a single intradiscal injection of 100 mg of VIA Disc NP mixed with sterile saline at one or two affected levels (L1-S1) or a sham procedure where a needle is inserted through the skin and muscle but does not penetrate the disc annulus. The treatment is delivered once, targeting 1 or 2 lumbar disc levels. During the study, participants will be monitored for treatment effectiveness and safety up to 26 weeks. Effectiveness is measured by the proportion achieving a meaningful improvement in pain scores from baseline to 26 weeks, and safety by reported treatment-related adverse events up to 12 weeks. Assessments include pain severity (VAS), disability scores (ODI), neurologic exams, and patient-reported outcomes. The total participation age range is 22 to 85 years old.

This research investigates the effectiveness and safety of combining capivasertib with CDK4/6 inhibitors and fulvestrant in adults with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer that is locally advanced, inoperable, or metastatic. It includes a Phase Ib dose-finding portion to establish safe dosages for the triple combination, followed by a Phase III study comparing this combination to CDK4/6 inhibitors plus fulvestrant alone. The study focuses on patients who have not received prior endocrine therapy for advanced disease and aims to assess added benefit in a high-risk population. During Phase Ib, participants receive capivasertib orally twice daily for 4 days followed by 3 days off each week, combined with fulvestrant injections and one of the CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) at varying doses to find the recommended dose for Phase III. In Phase III, participants are randomized to receive capivasertib plus fulvestrant and a CDK4/6 inhibitor at the established dose or fulvestrant plus a CDK4/6 inhibitor alone, with dosing schedules maintained over 28-day cycles. Participants undergo regular monitoring including scans for tumor assessment, blood tests, and safety evaluations over extended periods—up to 47 months for progression-free survival assessment. Researchers track adverse events, serious side effects, and treatment tolerability throughout. Mandatory tumor and blood samples are collected for biomarker analysis. The study evaluates key outcomes such as dose-limiting toxicities, treatment-related adverse events, and progression-free survival, supporting long-term safety and effectiveness evaluation.

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

Researchers are evaluating DCSZ11 as a single treatment and in combination with pembrolizumab in patients with advanced or metastatic solid tumors. This multicenter, open-label Phase 1 study includes a Dose Escalation Phase (Phase 1a) and a Dose Expansion/Optimization Phase (Phase 1b). The goal is to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of DCSZ11, including combinations with other therapies in certain relapsed or refractory solid tumors. DCSZ11 is given as an intravenous infusion every 3 weeks during the study. Phase 1a involves dose escalation of DCSZ11 alone and with pembrolizumab, increasing doses up to a maximum planned level. Phase 1b includes a dose expansion and optimization stage using a Simon two-stage design for certain cancer types. There is also a safety lead-in and expansion for DCSZ11 combined with standard-of-care treatments like doxorubicin for soft tissue sarcoma or tebentafusp for uveal melanoma. Participants will undergo evaluations including biopsies, imaging scans, and laboratory tests to monitor tumor response and safety. Researchers will track treatment emergent adverse events, dose-limiting toxicities, and overall response rates over periods ranging from 21 days to up to 3 years. Patients will be monitored closely during treatment cycles, and safety follow-up will be conducted to assess long-term effects and treatment tolerability.