TO-TAS3681-101: A Phase 1, Open-Label, Non-Randomized, Safety, Tolerability, and Pharmacokinetic Study of TAS3681 in Patients with Metastatic Castration-Resistant Prostate Cancer

About this Study

The purpose of the study is to investigate the safety and tolerability of TAS3681, to find the maximum tolerated dose (MTD)/recommended dose of TAS3681 (Escalation Phase).

Sponsor Protocol ID:TO-TAS3681-101
IRB Number:2021-0699
Actively Enrolling
Phase 1
July 12, 2022
Eligibility Criteria
18 years old
Both Male and Female

Inclusion Criteria
  • Must be at least 18 years of age
  • Histological or cytological evidence of metastatic castrated resistant prostate cancer
  • Ongoing androgen deprivation with serum testosterone less than 50 ng/dl
  • Ability to take medication by mouth
  • Willing to comply with scheduled visits and procedures

Exclusion Criteria
  • Heart problems such as heart failure or left ventricular dysfunction with ejection fraction of less than 40%
  • History of atrial fibrillation, atrial flutter, or paroxysmal supraventricular tachycardia
  • Presence of cardiac pacemaker or implantable cardioverter-defibrillator
  • History or presence of bradycardia or conduction abnormalities
  • History of myocardial infarction or severe unstable angina
  • Prior treatment with TAS3681
  • User of herbal products

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Participating Locations
Cancer Center and Research Institute - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Jessie Solise
Phone Number: 601-984-1963
Principal Investigator:Tang, Shou J, M.D.
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