Abraxis Completes Enrollment In Phase III Abraxane Study

Abraxis has completed patient enrollment of a pivotal, phase III clinical study. The study compares the Abraxane for injectable suspension with Taxol (paclitaxel) injection, both in combination with carboplatin, in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).

The phase III study involves 1,050 patients randomized in a one-to-one ratio to two treatment arms, patients in Arm A receive Abraxane 100 mg/m2 weekly plus carboplatin AUC 6 on Day 1 of a three-week treatment cycle; and patients in Arm B receive Taxol 200 mg/m2 weekly plus carboplatin AUC 6 on Day 1 of a three-week treatment cycle.

The primary study endpoint is disease response, measured as complete and partial responses as defined by Recist. Secondary study endpoints include; safety and tolerability, disease control rate and duration of response, progression-free survival (PFS), patient survival, and assessments of Abraxane efficacy correlated with specific tumor biomarkers, including secreted protein acidic and rich in cysteine (SPARC).