ANZCTR search results

A single-arm, open-label study to assess the overall safety of rovalpituzumab tesirine in participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer by evaluating the frequency of high grade (\>= Grade 3) select treatment-emergent adverse events (TEAEs).

The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis. Participants were enrolled in this study from the originating studies (JAHL, JAHM, JAIY) or were directly enrolled in the open-label arm.

The purpose of this study is to evaluate the efficacy and safety of baricitinib as monotherapy in participants with moderate to severe atopic dermatitis.

The purpose of this first in human and proof of concept study is to characterize the safety, tolerability and initial efficacy of CLL442 in patients with Squamous Cell Carcinoma in situ (SCCis) to enable further clinical development of CLL442.

Sepsis has been characterised as a dysregulated host response to infection. Adjunctive therapies targeting the inflammatory cascade are being increasingly explored, although to date, have failed to demonstrate consistent benefit, and sepsis continues to manifest poor outcomes. Hospital mortality in patients with septic shock remains as high as 22% in Australia and New Zealand. From a global perspective, 31 million sepsis and 19 million severe sepsis cases are expected to be treated in hospitals all over the world per year. To date, experimental data have reported that both high dose intravenous vitamin C and corticosteroids attenuate the acceleration of the inflammatory cascade and possibly reduce the endothelial injury characteristic of sepsis, enhance the release of endogenous catecholamines and improve vasopressor responsiveness. Therefore, the investigators plan to conduct a feasibility pilot prospective, multi-centre, randomised, open-label, trial in ICU patients with septic shock to test whether the intravenous administration of high dose Vitamin C (6g/d), Thiamine (400mg/d) and Hydrocortisone (200mg/d) leads to a more rapid resolution shock and vasopressor dependence.

This study will evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GDC-9545 as a single agent and in combination with palbociclib and/or luteinizing hormone-releasing hormone (LHRH) agonist in participants with advanced or metastatic estrogen receptor (ER)-positive (human epidermal growth factor receptor 2 \[HER2\]-negative) breast cancer.

he purpose of the study is to evaluate the efficacy, safety, and tolerability BGB-3111 plus obinutuzumab versus obinutuzumab alone in participants with relapsed/refractory non-Hodgkin follicular lymphoma.

The purpose of this study is to test how safe and effective the research study drug, pembrolizumab is as a treatment for patients with Hodgkin lymphoma who have not previously been treated for this disease and are unsuitable for standard treatment (adriamycin, bleomycin, vinblastine, dacarbazine ABVD).

Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), hormone receptor positive (HR+) breast cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration resistant prostate cancer (CRPC).

This is a bilateral, non-dispensing, randomized, subject masked, four visits, 3-period by 3- treatment crossover study. The objective of this study is to evaluate the effect of JJVC senofilcon A - based contact lens with new UV-blocker on vision and driving performance in both daytime and nighttime lighting under real world driving conditions. This will be achieved through field-based driving studies on a closed-road driving circuit at night and during the day. Quantitative methods will be used to assess vision and driving performance under a range of challenging conditions and appropriate masking, order of testing, randomization and control conditions will be used.