The purpose of this study is to evaluate the Safety and Pharmacokinetics of Oral Artesunate in patients with advanced hepatocellular carcinoma (HCC)
Artemisinins, compounds extracted from the herb Artemisia annua, are safe and effective FDA-approved antimalarial drugs. Recent studies have suggested that artemisinins also exert anti-angiogenic and cytotoxic effects on human cancer cells. Artesunate (ART) is a water soluble semisynthetic artemisinin with improved pharmacokinetic properties. A single-center phase I dose-escalation study evaluating the safety and pharmacokinetics of oral Artesunate in patients with Advanced HCC. Approximately 15 patients will be enrolled in this trial. Dose-escalation protocol: The first patient will receive 200 mg Artesunate once-daily for 14 days. If no dose-limiting toxicity (DLT) is observed after 14 days, the next patient will start at a daily dose of 300 mg Artesunate. If no DLT is observed after 14 days, a cohort of 3 patients will receive 400 mg once-daily for 14 days. For each subsequent cohort of 3 patients 200 mg will be added to the dose, until the maximum tolerated dose (MTD) is determined.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Oral Artesunate once-daily for 14 days, dose-escalation
Dept. of Hepatology & Gastroenterology Ghent University Hospital
Ghent, East-Flandres, Belgium
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 14 days
Maximum tolerated dose (MTD)
Time frame: 14 days
Pharmacokinetic analysis of Cmax, Cmin, Tmax, and AUC.
Time frame: 2 days
Time to tumor progression (TTP)
Time frame: Time from the first intake of Artesunate to radiological progression
Overall survival (OS)
Time frame: ime from the first intake of Artesunate to death
Quality of life based on the "Functional Assessment of Cancer Therapy Hep-30 scale" (FACT-Hep-30)
Time frame: 14 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.