Last updated on November 2019

Study of TAS3681 in Metastatic Castration Resistant Prostate Cancer

Brief description of study

The purpose of this trial is to investigate the safety and tolerability of TAS3681 and to find the maximum tolerated dose of TAS3681.

Detailed Study Description

This is a first in human, multinational, phase 1, open-label study of TAS3681 in patients with metastatic castration resistant prostate cancer (mCRPC)evaluating safety, tolerability, pharmacokinetics and preliminary antitumor activity in patients with mCRPC for which there is no standard therapy. Eligible patients will either be enrolled in the dose escalation phase to evaluate safety and determine the maximum tolerated dose for TAS3681, including a preliminary evaluation of food effect, or the expansion phase in which additional cohorts of patients may be enrolled to further evaluate safety and preliminary efficacy of TAS3681 at the MTD or at a lower dose.

Approximately 100 evaluable patients will be enrolled in the Dose Escalation Phase and approximately 100 patients will be enrolled in the Expansion Phase.

Clinical Study Identifier: NCT02566772

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Sarah Cannon Research Institute

Sarasota, FL United States
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Recruitment Status: Open

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