Prostate Cancer Clinical Trial
Study of TAS3681 in Metastatic Castration Resistant Prostate Cancer
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).
Full 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 Closed). Patients who are continuing to receive clinical benefit may receive drug in the extension part of the study after escalation and expansion are completed.
Eligibility Criteria
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:
I. 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:
QTcF ≥ 450 ms, history of QTc prolongation or predisposition for QTc prolongation or family history of sudden cardiac death or QT prolongation
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
Presence of cardiac pacemaker or implantable cardioverter-defibrillator
History or presence of bradycardia or conduction abnormalities
History or presence of cardiac arrest or unexplained syncope
Hypokalemia
History of myocardial infarction or severe unstable angina
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
Serious illness or medical condition that could affect the safety or tolerability of study treatments
Received prior treatment with TAS3681
User of herbal products
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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There are 30 Locations for this study
Sacramento California, 95817, United States
Sarasota Florida, 34232, United States
Tampa Florida, 33612, United States
Baltimore Maryland, 21201, United States
Jackson Missouri, 39213, United States
Omaha Nebraska, 68130, United States
Edison New Jersey, 08837, United States
Bronx New York, 10461, United States
New York New York, 10065, United States
Seattle Washington, 98109, United States
Madison Wisconsin, 53705, United States
Bordeaux , 33076, France
Lyon , 69008, France
Lyon , , France
Marseille , 13273, France
Montpellier , 34298, France
Nice , 06189, France
Paris , 75015, France
Rennes , 35042, France
Suresnes , 92151, France
Villejuif Cedex , 94805, France
Barcelona , 08035, Spain
Barcelona , 08908, Spain
Castellana , 12002, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Sabadell , 08208, Spain
Santander , 39008, Spain
London England, , United Kingdom
Manchester Greater Manchester, M20 4, United Kingdom
Sutton Surrey, SM2 5, United Kingdom
Sutton Surrey, SM2 5, United Kingdom
Cambridge , CB2 0, United Kingdom
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