Vergiate, Italy
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
3Span
100 weeksSponsor
TR TherapeuticsShepparton, 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
4Span
355 weeksSponsor
University of MelbourneShepparton, 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
3Span
314 weeksSponsor
Monash UniversityShepparton, Victoria
Recruiting
ANZUP - Non-clear Cell Post Immunotherapy CABozantinib (UNICAB)
Phase
2Span
264 weeksSponsor
Australian and New Zealand Urogenital and Prostate Cancer Trials GroupShepparton, 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
3Span
423 weeksSponsor
Stemline Therapeutics, Inc.Shepparton, Victoria
Recruiting
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
3Span
709 weeksSponsor
AstraZenecaShepparton
Recruiting
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
Phase
3Span
496 weeksSponsor
Eli Lilly and CompanyShepparton, 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
3Span
362 weeksSponsor
Eli Lilly and CompanyShepparton, 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
3Span
306 weeksSponsor
Eli Lilly and CompanyShepparton, Victoria
Recruiting