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news.Allos Therapeutics has initiated patient enrollment in a Phase IIb, randomized, multi-center study comparing PDX and Tarceva in patients with Stage IIIB/IV non-small cell lung cancer who are, or have been, cigarette smokers who have failed treatment with at least one prior platinum-based chemotherapy regimen.
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The objective of the Phase IIb study is to compare the efficacy of PDX to that of Tarceva. The primary endpoint of the study is overall survival. Secondary endpoints include response rate and progression-free survival, both compared to Tarceva, and the safety and tolerability of PDX. The study will seek to enroll 160 patients in up to 50 investigative sites worldwide.
In this study, patients will be randomized 1:1 to either the PDX arm or the Tarceva arm. Patients randomized to the PDX arm will receive PDX as an intravenous (IV) push administered on days 1 and 15 of a four-week/28 day cycle. The initial dose of PDX will be 230mg/m2, which, based on defined criteria, may be increased to 270mg/m2 or reduced in 40mg/m2 decrements. Patients randomized to the Tarceva arm will receive Tarceva 150mg/day orally daily for the four-week/28 day cycle. Patients in both arms will receive concurrent vitamin therapy of B12 and folic acid.
Pablo Cagnoni, chief medical officer of Allos, said: “Based on PDX’s preclinical and clinical profile in non-small cell lung cancer, we believe that PDX has the potential to offer a new treatment option for patients with this challenging disease.”