Randomized, Double-blind, Split-body, Placebo-controlled Phase Ib Study of Lipoxysan (Liposomal Recombinant Human Cu/Zn-Superoxide Dismutase) for the Prevention of Radiation-induced Dermatitis in Patients With Breast Cancer
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
To evaluate safety and tolerability of APN201
Adverse events, vital signs and laboratory assessments (hematology, serum chemistry) are used for safety evaluations.
From baseline until 1 day following the final radiotherapy fraction, assessed for a maximum of 28 radiotherapy fractions.
Austria: Agency for Health and Food Safety