Dose-Escalation Study Evaluating the Safety and Pharmacokinetics of Artesunate in Patients With Hepatocellular Carcinoma (DESPARTH)
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|ClinicalTrials.gov Identifier: NCT02304289|
Recruitment Status : Completed
First Posted : December 1, 2014
Last Update Posted : January 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Artesunate||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Dose-Escalation Study Evaluating the Safety and Pharmacokinetics of Oral Artesunate (ART) in Patients With Advanced Hepatocellular Carcinoma (HCC).|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Oral Artesunate
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.
Oral Artesunate once-daily for 14 days, dose-escalation
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304289
|Dept. of Hepatology & Gastroenterology Ghent University Hospital|
|Ghent, East-Flandres, Belgium, 9000|
|Principal Investigator:||Hans Van Vlierberghe, MD, PhD||University Ghent|