Clinical Research Directory

Edoxaban Versus Apixaban in Cancer-Associated Venous Thromboembolism

This prospective, multicenter, randomized, open-label, blinded-endpoint trial aims to compare the clinical efficacy and safety of edoxaban-based treatment versus apixaban-based treatment in patients with cancer-associated venous thromboembolism (CAT). A total of 2,300 patients with active cancer and objectively confirmed venous thromboembolism will be randomized in a 1:1 ratio to receive edoxaban-based or apixaban-based treatment. The primary objective is to determine whether edoxaban-based treatment is non-inferior to apixaban-based treatment with respect to net adverse clinical events (NACE), defined as a composite of recurrent venous thromboembolism, venous thromboembolism-related death, or major bleeding according to the International Society on Thrombosis and Haemostasis criteria.

Acute Ischemic Stroke in Patients With Active Cancer

The goal of this multicenter prospective observational study, conducted at 24 hospitals in Japan, is to learn about recurrent ischemic stroke in people with active cancer who develop acute ischemic stroke. One of the main objectives is to evaluate how often ischemic stroke recurs during follow-up. The main questions this study aims to answer are: * How often does ischemic stroke recur within 3 months after the initial stroke? * Which clinical factors may be associated with recurrent ischemic stroke? * What other clinical outcomes occur during follow-up? Participants will receive medical care determined by their treating physicians. Researchers will collect information about participants' cancer, stroke characteristics, test results, treatments, recurrent ischemic stroke, and other clinical outcomes. Researchers will also explore whether clinical factors are associated with recurrent ischemic stroke and other outcomes. This study will not assign participants to a specific treatment.

First-in-human Diagnostic Imaging Profile of the Theranostic Pair [68Ga]Ga-DOTA-STR-17126 and Low Dose [177Lu] Lu-DOTA-STR-17126 in Patients With Advanced or Metastatic Cancer

This is an open-label, first-in-human, exploratory Phase 0 study evaluating the safety and diagnostic imaging performance of the DOTA-STR-17126 theranostic pair in patients with advanced or metastatic breast or prostate cancer. The study investigates \[68Ga\]Ga-DOTA-STR-17126 for PET imaging and, in patients with positive GRPR uptake, a low dose of \[177Lu\]Lu-DOTA-STR-17126 for SPECT imaging and dosimetry. The primary objective is to assess safety and tolerability. Secondary objectives include evaluation of imaging quality, biodistribution, pharmacokinetics, and radiation dosimetry. Exploratory objectives assess correlations between GRPR expression in tumour tissue and imaging uptake. The study is conducted at a single centre in Australia, with 12 evaluable participants (up to 20 enrolled), and supports the development of a GRPR-targeted theranostic approach for personalised cancer management.