ArQule, Inc. (ARQL) announced positive top-line results from a randomized, double-blind, placebo-controlled Phase 2 trial of tivantinib as a single agent in metastatic prostate cancer. This trial was conducted under a Cooperative Research and Development Agreement with the National Cancer Institute's Cancer Therapy Evaluation Program. The principal investigator was Paul Monk, M.D. of The Ohio State University, Arthur James Cancer Hospital and Solove Research Institute.
In this trial, 78 patients were randomized 2 to 1 to receive either tivantinib as a single agent or placebo. During a pre-planned analysis, it was found that the trial met its primary endpoint of improving median progression-free survival (PFS) with tivantinib alone as compared to placebo. The results were highly statistically significant. Safety data were consistent with those observed in other trials of tivantinib.
The trial results are the subject of ongoing analyses and will be submitted by the investigators for presentation at a future medical conference.
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