Study of TAS3681 in Metastatic Castration Resistant Prostate Cancer

  • End date
    Oct 15, 2022
  • participants needed
  • sponsor
    Taiho Oncology, Inc.
Updated on 16 May 2021
Elizabeth Calleja, MD
Primary Contact
Sarah Cannon Research Institute (5.4 mi away) Contact
+10 other location


The purpose of this trial is to investigate the safety and tolerability of TAS3681, to find the maximum tolerated dose (MTD)/recommended dose of TAS3681 (Escalation Phase) and to further evaluate safety and preliminary efficacy of TAS3681 at the MTD/recommended dose (Expansion Phase).


This is a first in human, multinational, Phase 1, open-label study of TAS3681 evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity in patients with metastatic castration-resistant prostate cancer (mCRPC) for which there is no standard therapy. Eligible participants will be enrolled to evaluate safety and determine the MTD/recommended dose for TAS3681, including a preliminary evaluation of food effect and antitumor activity. The study will be conducted in 2 parts, Dose Escalation (Enrollment closed) and Expansion (Enrollment open), and will enroll up to approximately 200 patients.

Condition Metastatic Castration Resistant Prostate Cancer
Treatment TAS3681
Clinical Study IdentifierNCT02566772
SponsorTaiho Oncology, Inc.
Last Modified on16 May 2021


Yes No Not Sure

Inclusion Criteria

Male 18 years of age
Histological or cytological evidence of metastatic castrate resistant prostate cancer (excluding neuroendocrine differentiation and small cell histology) who are castration resistant and have
Dose escalation: documented progression defined in PCWG3 and/or intolerance to abiraterone and/or enzalutamide therapy, as well as 1 or more chemotherapies
Group A: documented progression after abiraterone or enzalutamide and chemotherapy consisting of no more than 2 prior taxane-based therapies
ii. Group B: documented progression after only abiraterone or enzalutamide
therapy without any chemotherapy
iii. Measurable disease per RECIST 1.1 and/or bone metastases
\. ECOG performance status of 1 on Day 1 Cycle 1
\. Ongoing androgen deprivation with serum testosterone <50 ng/dL
\. Expansion Phase only: willingness to undergo baseline core biopsies, if
\. Ability to take medication orally
\. Adequate organ function
\. Agree to use effective contraception during the study and for 30 days
after the last dose of TAS3681
\. Willing to comply with scheduled visits and procedures

Exclusion Criteria

Presence of cardiac pacemaker or implantable cardioverter-defibrillator
History or presence of bradycardia or conduction abnormalities
History of myocardial infarction or severe unstable angina
Serious illness or medical condition that could affect the safety or tolerability of study treatments
QTcF 450 ms, history of QTc prolongation or predisposition for QTc prolongation or family history of sudden cardiac death or QT prolongation
User of herbal products
History or presence of heart failure or left ventricular dysfunction with ejection fraction <40% within the previous 6 months; if >6 months cardiac function within normal limits and free of cardiac-related symptoms
History or presence of atrial fibrillation, atrial flutter, or paroxysmal supraventricular tachycardia; the presence or history of ventricular arrhythmias including ventricular fibrillation and ventricular tachycardia
History or presence of cardiac arrest or unexplained syncope
Any medication administered within 2 weeks prior to 1st dose of TAS3681 that is known to prolong the QT interval or be arrhythmogenic
Received G-CSF, radiotherapy for extended field, anticancer chemotherapy, investigational agents, or major surgery within 4 weeks of study drug administration; receipt of anticoagulant or CYP3A inhibitor within 2 weeks of study drug administration
Received prior treatment with TAS3681
Any condition or reason that in the opinion of the investigator, interferes with the ability of the participant to participate in the trial
To be eligible to participate in the food effect assessment (Escalation Phase only), participants must not have a history or presence of any clinically significant abnormality involving the gastrointestinal tract and an inability to fast for a minimum of 8 hours
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note