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Trial record 1 of 1 for:    TAS-3681
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Study of TAS3681 in Metastatic Castration Resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02566772
Recruitment Status : Recruiting
First Posted : October 2, 2015
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Tracking Information
First Submitted Date  ICMJE September 25, 2015
First Posted Date  ICMJE October 2, 2015
Last Update Posted Date November 1, 2019
Actual Study Start Date  ICMJE March 2016
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • Number of participants with dose limiting toxicity [ Time Frame: Through 1 month ]
  • Number of patients with adverse events and significant ECG abnormalities [ Time Frame: through 6 months (or until patient discontinuation) ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
Number of participants with dose limiting toxicity as assessed by CTCAE v4.0 [ Time Frame: Up to 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • Prostate Specific Antigen (PSA) response [ Time Frame: Up to 6 months (or until patient discontinuation) ]
  • Maximum concentration of TAS3681 in plasma [ Time Frame: At Day 15 in Cycle 1 (each cycle is 28 days) ]
  • Time to reach maximum concentration of TAS3681 [ Time Frame: At Day 15 in Cycle 1 (each cycle is 28 days) ]
  • Area under the concentration-time curve of TAS3681 [ Time Frame: At Day 15 in Cycle 1 (each cycle is 28 days) ]
  • Terminal half-life time of TAS3681 [ Time Frame: At Day 15 in Cycle 1 (each cycle is 28 days) ]
  • Accumulation ratio of TAS3681 [ Time Frame: At Day 15 in Cycle 1 (each cycle is 28 days) ]
  • Tumor response as per RECIST 1.1 and PCWG3 [ Time Frame: Through 6 months ( or until patient discontinuation) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
Prostate Specific Antigen (PSA) response [ Time Frame: Up to 6 months ]
Current Other Pre-specified Outcome Measures
 (submitted: May 14, 2019)
  • Change from baseline in Circulating Tumor Cell (CTC) number in blood [ Time Frame: Baseline, end of week 4, at the end of every 12 weeks, and end of every 12 weeks through study completion, an average of 6 months ]
  • Number of patients with AR-v7 positivity in circulating tumor cells [ Time Frame: Baseline ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of TAS3681 in Metastatic Castration Resistant Prostate Cancer
Official Title  ICMJE A Phase 1, Open-Label, Non-Randomized, Safety, Tolerability and Pharmacokinetic Study of TAS3681 in Patients With Metastatic Castration Resistant Prostate Cancer
Brief Summary The purpose of this trial is to investigate the safety and tolerability of TAS3681 and to find the maximum tolerated dose of TAS3681.
Detailed Description

This is a first in human, multinational, phase 1, open-label study of TAS3681 in patients with metastatic castration resistant prostate cancer (mCRPC)evaluating safety, tolerability, pharmacokinetics and preliminary antitumor activity in patients with mCRPC for which there is no standard therapy. Eligible patients will either be enrolled in the dose escalation phase to evaluate safety and determine the maximum tolerated dose for TAS3681, including a preliminary evaluation of food effect, or the expansion phase in which additional cohorts of patients may be enrolled to further evaluate safety and preliminary efficacy of TAS3681 at the MTD or at a lower dose.

Approximately 100 evaluable patients will be enrolled in the Dose Escalation Phase and approximately 100 patients will be enrolled in the Expansion Phase.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Castration Resistant Prostate Cancer
Intervention  ICMJE Drug: TAS3681
TAS3681 will be provided as 25 mg and 100 mg tablets to be administered orally for 28 day cycles, Number of cycles: approximately 6 or until discontinuation criteria is met.
Study Arms  ICMJE Experimental: TAS3681
All patients will receive TAS3681 in 28 day cycles,. The study will enroll patients who have progressed after abiraterone or enzalutamide (expansion phase) and those who have progressed after abiraterone, enzalutamide and chemotherapy (dose escalation phase). - Number of cycles: approximately 6 or until discontinuation criteria is met. Eleven dose escalation cohorts are planned, one of which will include preliminary assessment of food effect. The MTD/recommended dose for further development will be used for patients in the expansion phase.
Intervention: Drug: TAS3681
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019)
200
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2015)
130
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male > 18 years of age
  2. Histological or cytological evidence of metastatic castrate resistant prostate cancer with progression defined in PCWG3; Scher HI 2015 intolerance of standard chemotherapy
  3. ECOG performance status of < 1 on Day1 Cycle 1
  4. Ongoing androgen deprivation with serum testosterone < 50 ng/dl
  5. Ability to take medication orally
  6. Adequate organ function
  7. Willing to comply with scheduled visits and procedures

Exclusion Criteria:

  1. QTc > 450ms, 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 cardia arrest or unexplained syncope
  7. Hypokalemia
  8. History of myocardial infarction or severe unstable angina
  9. Any medication administered within 4 weeks prior to 1st dose of TAS3681 that is known to affect QT interval or arrhythmogenic
  10. Serious illness or medical condition that could affect the safety or tolerability of study treatments
  11. Received prior treatment of TAS3681
  12. User of herbal products
  13. Any condition or reason that in the opinion of the investigator, interferes with the ability of the patient to participate in the trial.
  14. To be eligible to participate in the food effect assessment, patients 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elizabeth Calleja, MD +1-609-285-5280 clinicaltrialinfo@taihooncology.com
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02566772
Other Study ID Numbers  ICMJE TO-TAS3681-101
2015-002745-55 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taiho Oncology, Inc.
Study Sponsor  ICMJE Taiho Oncology, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Taiho Oncology, Inc.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP