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


Condition: Metastatic Castration Resistant Prostate Cancer

Intervention:

  • Drug: TAS3681

Purpose: The purpose of this trial is to investigate the safety and tolerability of TAS3681 and to find the maximum tolerated dose of TAS3681.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02566772

Sponsor: Taiho Oncology, Inc.

Primary Outcome Measures:

  • Measure: Number of participants with dose limiting toxicity
  • Time Frame: Through 1 month
  • Safety Issue:
  • Measure: Number of patients with adverse events and significant ECG abnormalities
  • Time Frame: through 6 months (or until patient discontinuation)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Prostate Specific Antigen (PSA) response
  • Time Frame: Up to 6 months (or until patient discontinuation)
  • Safety Issue:
  • Measure: Maximum concentration of TAS3681 in plasma
  • Time Frame: At Day 15 in Cycle 1 (each cycle is 28 days)
  • Safety Issue:
  • Measure: Time to reach maximum concentration of TAS3681
  • Time Frame: At Day 15 in Cycle 1 (each cycle is 28 days)
  • Safety Issue:
  • Measure: Area under the concentration-time curve of TAS3681
  • Time Frame: At Day 15 in Cycle 1 (each cycle is 28 days)
  • Safety Issue:
  • Measure: Terminal half-life time of TAS3681
  • Time Frame: At Day 15 in Cycle 1 (each cycle is 28 days)
  • Safety Issue:
  • Measure: Accumulation ratio of TAS3681
  • Time Frame: At Day 15 in Cycle 1 (each cycle is 28 days)
  • Safety Issue:
  • Measure: Tumor response as per RECIST 1.1 and PCWG3
  • Time Frame: Through 6 months ( or until patient discontinuation)
  • Safety Issue:

Estimated Enrollment: 200

Study Start Date: March 2016

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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

Contact:

  • Elizabeth Calleja, MD
  • +1-609-285-5280

Locations:

  • Univeristy of California Davis Comprehensive Cancer Center
  • Sacramento California 95817 United States
  • Sarah Cannon Research Institute
  • Sarasota Florida 34232 United States
  • Memorial Sloan Kettering Cancer Center
  • New York New York 10065 United States
  • Seattle Cancer Care Alliance
  • Seattle Washington 98109 United States
  • The Christie Clinic
  • Manchester Greater Manchester M20 4BX United Kingdom
  • Institute of Cancer Research
  • Sutton Surrey SM2 5NG United Kingdom

View trial on ClinicalTrials.gov