Phase 3 trial of Abraxane for metastatic malignant melanoma

Abraxis BioScience presented trial design information from its ongoing Phase 3, multicenter, open-label, registration trial investigating Abraxane (nanoparticle albumin bound (nab)-paclitaxel for injectable suspension) for the treatment of metastatic malignant melanoma. Cytotoxic chemotherapy-naive patients with metastatic malignant melanoma were randomized to receive either Abraxane on days 1, 8, and 15 every four weeks or dacarbazine on day 1 every 21 days. The primary efficacy endpoint is progression-free survival (PFS) and the main secondary endpoint is overall survival (OS). Other secondary endpoints include safety and tolerability, Abraxane pharmacokinetic parameters, effects of therapy on and the relationship of response to the levels of SPARC and gene methylation, mutational and other biomarkers, response rate, stable disease rate at ≥16 weeks, and duration of response.

Abraxane is a solvent-free protein-bound chemotherapy agent combining paclitaxel with albumin. By wrapping the albumin around the active drug, Abraxane can be administered to patients at higher doses, delivering higher concentrations of paclitaxel to the tumor site than solvent-based paclitaxel. Abraxane is currently in various stages of investigation for the treatment of the following cancers: expanded applications for metastatic breast, non-small cell lung, malignant melanoma, pancreatic and gastric.

For more information call (800) 564-0126 [option #2] or visit www.abraxane.com.