Safety and pharmacokinetics of Withaferin-A in advanced stage high grade osteosarcoma: A phase I trial.

ABSTRACT: BACKGROUND:Withaferin-A (WA), an active principle obtained from a traditional Indian herb known as Ashwagandha or the Indian ginseng, has been shown to prevent and cure urethane-induced lung tumors in mice, and also inhibit the growth of transplanted sarcoma in mice. OBJECTIVES:In this study, we evaluated the safety and pharmacokinetics of WA in patients with advanced stage high-grade osteosarcoma. METHODS:A phase I dose escalation study was planned using the classical 3 + 3 design (C33D). Dose escalation cohorts comprised of 72, 108, 144 and 216 mg of WA administered in two to four divided doses per day. Three patients were enrolled in each cohort and the last patient was observed for at least 30 days for any dose-limiting toxicity before progressing to a higher cohort. Pharmacokinetic st

SUBMITTER: Pires N 

PROVIDER: S-EPMC7125369 | biostudies-literature | 2020 Jan - Mar

REPOSITORIES: biostudies-literature