Clinical Trials /

Study of TAS3681 in Metastatic Castration Resistant Prostate Cancer

NCT02566772

Description:

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

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: TO-TAS3681-101
  • SECONDARY ID: 2015-002745-55
  • NCT ID: NCT02566772

Conditions

  • Metastatic Castration Resistant Prostate Cancer

Interventions

DrugSynonymsArms
TAS3681TAS3681

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
TAS3681ExperimentalAll 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.
  • TAS3681

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with dose limiting toxicity
Time Frame:Through 1 month
Safety Issue:
Description:

Secondary Outcome Measures

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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Taiho Oncology, Inc.

Trial Keywords

  • Prostate Cancer

Last Updated

October 30, 2019