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news.Allos Therapeutics has started patient enrollment in a Phase II, open-label, single-arm, multi-center study of pralatrexate in patients with advanced or metastatic relapsed transitional cell carcinoma of the urinary bladder.
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The primary endpoint of the study is objective response rate (complete and partial response). Secondary endpoints include duration of response, clinical benefit rate, progression-free survival (PFS), overall survival and the safety and tolerability of pralatrexate (PDX).
The study will seek to enroll approximately 41 patients in up to 20 investigative sites worldwide. In this study, patients will receive PDX as an intravenous push administered on days one and 15 of a four-week/28 day cycle.
The initial dose of PDX will be 190mg/m2, which may be adjusted based on criteria defined in the protocol. Patients will receive concurrent vitamin therapy of B12 and folic acid.
Pablo Cagnoni, chief medical officer of Allos, said: “Given the established role of antifolates in the treatment of bladder cancer, we believe this trial represents an important opportunity to evaluate the potential of PDX in this setting.”