Prostate Cancer Clinical Trial

Study of TAS3681 in Metastatic Castration Resistant Prostate Cancer

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).

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Full Description

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.

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Eligibility Criteria

Inclusion Criteria:

Male ≥18 years of age

Histological or cytological evidence of metastatic castrate resistant prostate cancer (excluding neuroendocrine differentiation and small cell histology) who are castration resistant and have:

Dose escalation: documented progression defined in PCWG3 and/or intolerance to abiraterone and/or enzalutamide therapy, as well as 1 or more chemotherapies.
Expansion:

I. 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

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

Exclusion Criteria:

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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

200

Study ID:

NCT02566772

Recruitment Status:

Active, not recruiting

Sponsor:

Taiho Oncology, Inc.

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There are 35 Locations for this study

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Univeristy of California Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
Yale University
New Haven Connecticut, 06520, United States
Florida Cancer Specialists & Research Institute
Sarasota Florida, 34232, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
University of Maryland Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
UMMC-Cancer Center and Research Institute
Jackson Missouri, 39213, United States
GU Research Network / Urology Cancer Center
Omaha Nebraska, 68130, United States
Premier Oncology Group
Edison New Jersey, 08837, United States
Montefiore Medical Center
Bronx New York, 10461, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Associated Medical Professionals of NY, PLLC
Syracuse New York, , United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
University of Wisconsin-Carbone Cancer Center
Madison Wisconsin, 53705, United States
Cliniques Universitaires Saint-Luc
Brussels , 1200, Belgium
Institut Jules Bordet
Brussel , 1000, Belgium
Institut Bergonie
Bordeaux , 33076, France
Centre Jean Perrin
Clermont Ferrand , 63011, France
Centre Léon BERARD
Lyon , 69008, France
Hospices Civils de Lyon
Lyon , , France
Institut Paoli Calmettes
Marseille , 13273, France
Institut régional du Cancer de Montpellier - ICM Val d'Aurelle
Montpellier , 34298, France
Centre Antoine Lacassagne
Nice , 06189, France
HEGP- Hôpital Européen Georges Pompidou
Paris , 75015, France
Centre eugenie Marquis
Rennes , 35042, France
Hopital Foch
Suresnes , 92151, France
Gustave Roussy
Villejuif Cedex , 94805, France
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Institut Catala d Oncologia - L Hospitalet de Llobregat
Barcelona , 08908, Spain
Hospital Provincial de Castellon
Castellana , 12002, Spain
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain
Hospital 12 de Octubre
Madrid , 28041, Spain
Hospital Universitari Parc Taulí
Sabadell , 08208, Spain
Hospital Marques de Valdecilla
Santander , 39008, Spain
Sarah Cannon Research Institute UK
London England, , United Kingdom
The Christie NHS Foundation Trust- The Christie Clinic
Manchester Greater Manchester, M20 4, United Kingdom
Royal Marsden Hospital (RMH) NHS Foundation Trust
Sutton Surrey, SM2 5, United Kingdom
Royal Marsden Hospital (RMH) NHS Foundation Trust (DDU)
Sutton Surrey, SM2 5, United Kingdom
Cambridge University Hospitals NHS Foundation
Cambridge , CB2 0, United Kingdom
University of Glasgow - Institute of Cancer Sciences;
Glasgow , G12 8, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

200

Study ID:

NCT02566772

Recruitment Status:

Active, not recruiting

Sponsor:


Taiho Oncology, Inc.

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