ALLOS INITIATES PHASE I PDX STUDY IN PATIENTS WITH NON-SMALL CELL LUNG CANCER

Allos Therapeutics has initiated a Phase I dose-escalation study of its investigational drug PDX (pralatrexate) with vitamin B12 and folic acid supplementation in patients with previously-treated (Stage IIIB-IV) advanced non-small cell lung cancer (NSCLC).

This open-label, nonrandomized study will seek to enroll one to six patients per treatment level cohort who have received one prior chemotherapy regimen and may or may not have received an EGFR Kinase inhibitor to test the safety, tolerability and pharmacokinetics (PK) of escalating doses of PDX.

To determine the maximum-tolerated dose of PDX when administered with concurrent vitamin B12 and folic acid supplementation, patients will receive a starting dose of 150 mg/m2. Subsequent cohorts will receive doses of PDX increasing in 40 mg/m2 increments until protocol-defined dose-limiting toxicities (DLTs) occur. Patients will receive their specific PDX dose intravenously twice during a four- to six-week period. Vitamin supplementation will be consistent for all patients regardless of PDX dose.

Safety endpoints for the study include DLTs, treatment-related adverse events (AEs), PK/AE correlation and laboratory values.