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  • Tissue Repair Gel in Venous Leg Ulcers in AU/US

    This is an outpatient, randomized, parallel- group, double-blind, multicenter, 16-week study with 2 treatment arms: TR987 0.1% gel + Standard of Care and Standard of Care alone in participants who have a non-healing Venous Leg Ulcer (VLU). The primary objective is to assess the proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit. Secondary endpoints include: - Proportion of participants with Complete Closure of the target ulcer at or before the Week 16 visit AND for whom the ulcer remains closed at the 3-Month Follow-Up visit after such closure (a composite endpoint). - Change from baseline in participant's perception of pain level at 12 weeks. - Percent change from baseline in the target ulcer area at 12 and 16 weeks. In the event of Complete Closure before these time points, the target ulcer area will be deemed to be zero at those time points for purposes of calculation of this endpoint. - Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit. - Proportion of participants with any significant reduction in pain at or before 12 weeks. There are also some supplementary and safety endpoints.

    Phase

    3

    Span

    100 weeks

    Sponsor

    TR Therapeutics

    Shepparton, Victoria

    Recruiting

  • Staphylococcus Aureus Network Adaptive Platform Trial

    Infection of the bloodstream with the bacterium Staphylococcus aureus (Staphylococcus aureus bacteraemia, SAB) is a serious infection that results in 15-30% of affected patients dying within three months of acquiring the infection. Treatment of this infection requires patients to be hospitalised, treated with prolonged antibiotics through an intravenous line, and carefully examined for the occurrence of complications associated with this condition. At present, there are many treatment options in current use, with no clear agreement as to which of these is best. The SNAP trial aims to identify which treatment options for SAB results in the fewest patients dying within the first 90 days after an infection. In contrast to a conventional clinical trial, the SNAP trial will examine multiple different treatment options at once. Patients will be randomly assigned to different concurrent treatment options currently considered acceptable in routine medical care, but as the trial progresses, more patients will be assigned to treatments that appear to have better outcomes than those with worse outcomes. The trial will adapt to accumulating trial evidence, on a regular basis, by removing treatment options found to be inferior, incorporating new treatment options, and ensuring that all patients in the trial receive the best treatments once they have been identified. Over time, we hope to determine the best combination of treatment options for patients with SAB. The SNAP Trial infrastructure will also support a number of sub-studies. A list of all active sub-studies can be found on the SNAP website: https://www.snaptrial.com.au/substudies.

    Phase

    4

    Span

    355 weeks

    Sponsor

    University of Melbourne

    Shepparton, Victoria

    Recruiting

  • Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial

    The Trial's purpose is to evaluate the effectiveness of lidocaine infusions commenced during surgery and extending up to 24 hours postoperatively, on the incidence of moderate or severe chronic post-surgical pain (CPSP) detected one year following surgery in female patients undergoing elective breast cancer surgery. The trial has 90% power to detect a clinically meaningful (25%) reduction in the incidence of the primary outcome. Secondary outcomes include safety events, analgesic efficacy (pain scores and opioid consumption), neuropathic characteristics of CPSP, and psychological and quality of life outcomes.

    Phase

    3

    Span

    314 weeks

    Sponsor

    Monash University

    Shepparton, Victoria

    Recruiting

  • ANZUP - Non-clear Cell Post Immunotherapy CABozantinib (UNICAB)

    Phase

    2

    Span

    264 weeks

    Sponsor

    Australian and New Zealand Urogenital and Prostate Cancer Trials Group

    Shepparton, Victoria

    Recruiting

  • A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence

    Phase

    3

    Span

    423 weeks

    Sponsor

    Stemline Therapeutics, Inc.

    Shepparton, Victoria

    Recruiting

  • A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

    Phase

    3

    Span

    639 weeks

    Sponsor

    Hoffmann-La Roche

    Shepparton, Victoria

    Recruiting

  • An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

    This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

    Phase

    3

    Span

    709 weeks

    Sponsor

    AstraZeneca

    Shepparton

    Recruiting

  • A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

    Phase

    3

    Span

    496 weeks

    Sponsor

    Eli Lilly and Company

    Shepparton, Victoria

    Recruiting

  • Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer

    Phase

    3

    Span

    362 weeks

    Sponsor

    Eli Lilly and Company

    Shepparton, Victoria

    Recruiting

  • A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer

    Dose Optimization, Part A, and Part B are randomized. Safety Lead-In for Part B is single arm, non-randomized.

    Phase

    3

    Span

    306 weeks

    Sponsor

    Eli Lilly and Company

    Shepparton, Victoria

    Recruiting

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