A Phase I Trial of AEG35156 Administered by 2-Hour Intravenous Infusion in Patients With Advanced Cancers
This is a Phase I study, single-arm, open-label, dose escalation study to establish the
recommended dose and activity of AEG35156 administered as a 2-hour daily infusion over 3
days initially followed by weekly 2-hour intravenous infusions in patients with advanced
cancers. Subjects eligible for study entry must have proven advanced or metastatic cancer
refactory to conventional treatment or for which no conventional therapy exists. The
starting dose will be a fixed dose of 60 mg/day with escalation by steps of 50 to 100% in
successive cohorts. Approximately of 30 patients will be entered in the study to determine
the maximum tolerated dose.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose level at which AEG35156 is well tolerated based upon development of toxicities during the first cycle of therapy unless delayed or cumulative toxicity is encountered. Assessments done weekly.
Jacques Jolivet, MD
Aegera Therapeutics Inc.
United Kingdom: Medicines and Healthcare Products Regulatory Agency