Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

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).

Official Title

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

Details

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.

Keywords

Metastatic Castration Resistant Prostate Cancer Prostate Cancer Prostatic Neoplasms TAS3681

Eligibility

You can join if…

Open to males ages 18 years and up

  1. Male ≥18 years of age
  2. Histological or cytological evidence of metastatic castrate resistant prostate cancer (excluding neuroendocrine differentiation and small cell histology) who are castration resistant and have:
  3. Dose escalation: documented progression defined in PCWG3 and/or intolerance to abiraterone and/or enzalutamide therapy, as well as 1 or more chemotherapies.
  4. Expansion:
  5. 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

  1. ECOG performance status of ≤1 on Day 1 Cycle 1
  2. Ongoing androgen deprivation with serum testosterone <50 ng/dL
  3. Expansion Phase only: willingness to undergo baseline core biopsies, if feasible
  4. Ability to take medication orally
  5. Adequate organ function
  6. Agree to use effective contraception during the study and for 30 days after the last dose of TAS3681
  7. Willing to comply with scheduled visits and procedures

You CAN'T join if...

  1. QTcF ≥ 450 ms, history of QTc prolongation or predisposition for QTc prolongation or family history of sudden cardiac death or QT prolongation
  2. 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
  3. 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
  4. Presence of cardiac pacemaker or implantable cardioverter-defibrillator
  5. History or presence of bradycardia or conduction abnormalities
  6. History or presence of cardiac arrest or unexplained syncope
  7. Hypokalemia
  8. History of myocardial infarction or severe unstable angina
  9. Any medication administered within 2 weeks prior to 1st dose of TAS3681 that is known to prolong the QT interval or be arrhythmogenic
  10. . 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
  11. . Serious illness or medical condition that could affect the safety or tolerability of study treatments
  12. . Received prior treatment with TAS3681
  13. . User of herbal products
  14. . Any condition or reason that in the opinion of the investigator, interferes with the ability of the participant to participate in the trial
  15. . 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

Locations

  • Univeristy of California Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • Seattle Cancer Care Alliance accepting new patients
    Seattle Washington 98109 United States
  • Seattle Cancer Care Alliance accepting new patients
    Seattle Washington 98109 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Taiho Oncology, Inc.
Links
Sign up for this study
ID
NCT02566772
Phase
Phase 1
Study Type
Interventional
Last Updated