Detergent and alcohol free formulation of cabazitaxel: Safety and pharmacokinetics of escalating dose of cabazitaxel lipid suspension (CLS) in patients with advanced solid maliganancies.

e14019Background: Cabazitaxel commercially called JEVTANA is a treatment for metastatic castration-resistant prostate cancer (mCRPC) patients progressing after docetaxel therapy. Cabazitaxel Lipid Suspension (CLS) is a detergent and alcohol-free aqueous based lipid formulation that can circumvent the toxicity and hypersensitivity reactions caused by excipients (polysorbate 80 and ethanol) of JEVTANA. Methods: An open label and multicentric clinical study was conducted to evaluate the safety and Pharmacokinetics (PK) at escalating doses (15, 20 and 25 mg/m2) of CLS and at 25 mg/m2 dose of JEVTANA in solid tumor cancer patients. A total of 23 venous blood samples were collected per patient and PK parameters were calculated by non-compartmental model using Phoenix WinNonlin version 6.4. Dose proportionality in CLS treated patients was evaluated using PROC MIXED of SAS version 9.3. Results: A total of 32 adverse events (AEs) were reported in 11 patients during the conduct of study. At 15 mg/m2, 7 adverse even...