The US Food & Drug Administration has placed a hold on all clinical trials evaluating GTx Inc's prostate cancer drug Capesaris (GTx-758) after the company reported to the regulatory agency that there was an increased risk of blood clots (venous thromboembolic events) in patients given Capesaris at doses of 1000 mg and higher.
GTx was running a number of clinical trials of Capesaris: a Phase II loading dose finding trial and a Phase IIb maintenance dose finding trial as a potential primary androgen deprivation therapy for advanced prostate cancer and secondary hormonal treatment, as well as a Phase II trial in men with castration resistant prostate cancer.
GTx will now consider lowering the dosage of the drug in future trials.
Source: Therapeutics Daily
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