This open-label, non-randomized study will seek to enroll patients 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 of escalating doses of PDX (pralatrexate).
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 150mg/m2. Subsequent cohorts will receive doses of PDX increasing in 40mg/m2 increments until protocol-defined dose limiting toxicities (DLTs) occur.
Allos expects to begin a phase II trial of PDX in non-small cell lung cancer (NSCLC) once the appropriate dosing has been determined.
Results of an earlier phase II trial demonstrated improved response rate and symptomatic benefits in patients with stage IIIb or IV NSCLC who received PDX therapy. Median survival time of patients enrolled in the study was 13.5 months, with one and two-year survival rates of 56% and 36%, respectively. Ten percent of PDX-treated patients had confirmed durable responses and 31% had stable disease.