Study of TAS3681 in Metastatic Castration Resistant Prostate Cancer

  • STATUS
    Recruiting
  • End date
    Oct 15, 2022
  • participants needed
    200
  • sponsor
    Taiho Oncology, Inc.
Updated on 16 May 2021
Investigator
Elizabeth Calleja, MD
Primary Contact
Sarah Cannon Research Institute (5.4 mi away) Contact
+10 other location

Summary

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).

Description

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.

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

Eligibility

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
Expansion
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
feasible
\. 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
Hypokalemia
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
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