Determine MTD and to Evaluate PK, Safety/Tolerability and Efficacy Profiles of Antroquinonol (Hocena®) in NSCLC Patients Refractory to Conventional Treatment Modalities
1. Antroquinonol, a novel cyclohexenone compound, is a purified compound from extract of
2. The pharmacological effects of antroquinonol were postulated to exert its
antitumorigenesis effects through interactions to primary targets of epidermal growth
factor receptor (EGFR)/Akt/mitogen-activated protein kinase (MAPK).
3. In vivo study in NOD/SCID mice with A549 subcutaneous xenografts consistently showed
tumor growth suppression after 2 weeks of oral 30 and 60 mg/kg antroquinonol treatment.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine MTD and dose limiting toxicities (DLTs) of antroquinonol
There are two phases in this study, the accelerated titration phase and the standard titration phase. MT is defined as any grade 2 toxicity and DLT is defined as any grade 3 or above toxicity by the National Cancer Institute (NCI)Common Terminology Criteria for Adverse Event (CTCAE) version 4.03 as determined by the investigator to be at least possibly related in causality to the treatment. Nausea, vomiting and diarrhea of grade 3 or more are to be counted as DLT only if they remain at grade 3 or more despite adequate treatment.
DLT is to be observed during 4 week period
Woei-Yau Kao, M.D.
Tri-Service General Hospital
United States: Food and Drug Administration