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Trial record 3 of 44 for:    MEAL prostate

Study of TAS3681 in Metastatic Castration Resistant Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Taiho Oncology, Inc.
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.
ClinicalTrials.gov Identifier:
NCT02566772
First received: September 25, 2015
Last updated: August 1, 2016
Last verified: August 2016
  Purpose
The purpose of this trial is to investigate the safety and tolerability of TAS3681 and to find the maximum tolerated dose of TAS3681.

Condition Intervention Phase
Metastatic Castration Resistant Prostate Cancer
Drug: TAS3681
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Non-Randomized, Safety, Tolerability and Pharmacokinetic Study of TAS3681 in Patients With Metastatic Castration Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Taiho Oncology, Inc.:

Primary Outcome Measures:
  • Number of participants with dose limiting toxicity as assessed by CTCAE v4.0 [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prostate Specific Antigen (PSA) response [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: March 2016
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAS3681
TAS3681 will be provided as 25 mg and 100 mg tablets to be administered QD orally for 28 days, at least 1 hour before or 2 hours after a meal. Number of cycles: approximately 6 or until discontinuation criteria is met, followed by an expansion phase..
Drug: TAS3681
TAS3681 will be provided as 25 mg and 100 mg tablets to be administered QD orally for 28 days, at least 1 hour before or 2 hours after a meal. Number of cycles: approximately 6 or until discontinuation criteria is met.

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 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 50 evaluable patients will be enrolled in the Dose Escalation Phase and approximately 80 patients will be enrolled in the Expansion Phase.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male > 18 years of age
  2. Histological or cytological evidence of metastatic prostate cancer with progression defined in PCWG3; Scher HI 2015 and 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 bradydysrhythmia 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. Received any treatments prohibited in this trial
  11. Serious illness or medical condition that could affect the safety or tolerability of study treatments
  12. Received prior treatment of TAS3681
  13. User of herbal products
  14. Any condition or reason that in the opinion of the investigator, interferes with the ability of the patient to participate in the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02566772

Contacts
Contact: Takekazu Aoyama, MD, PhD +1-609-285-5248 aoyama@taihooncology.com

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Takekazu Aoyama, MD, PhD    609-285-5248    aoyama@taihooncology.com   
United Kingdom
Institute of Cancer Research Recruiting
Sutton, Surrey, United Kingdom, SM2 5NG
Contact: Takekazu Aoyama, MD, PhD    +1-609-285-5248    aoyama@taihooncology.com   
Sponsors and Collaborators
Taiho Oncology, Inc.
  More Information

Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02566772     History of Changes
Other Study ID Numbers: TO-TAS3681-101  2015-002745-55 
Study First Received: September 25, 2015
Last Updated: August 1, 2016
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Keywords provided by Taiho Oncology, Inc.:
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on December 02, 2016