Study of TAS3681 in Metastatic Castration Resistant Prostate Cancer
Completed · Phase 1
Conditions studied: Metastatic Castration Resistant Prostate Cancer
In brief
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).
Key facts
- Study ID
- NCT02566772
- Run by
- Taiho Oncology, Inc.
- People needed
- 130
- Starts
- 2016-03-01
- Expected to finish
- 2024-04-26
- Last updated by the study team
- 2024-09-03
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Univeristy of California Davis Comprehensive Cancer Center — Sacramento, California, United States
- Florida Cancer Specialists & Research Institute — Sarasota, Florida, United States
- Moffitt Cancer Center — Tampa, Florida, United States
- University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
- UMMC-Cancer Center and Research Institute — Jackson, Missouri, United States
- GU Research Network / Urology Cancer Center — Omaha, Nebraska, United States
- Premier Oncology Group — Edison, New Jersey, United States
- MSKCC — New York, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Seattle Cancer Care Alliance — Seattle, Washington, United States
- University of Wisconsin-Carbone Cancer Center — Madison, Wisconsin, United States
- Institut Bergonie — Bordeaux, France
- Centre Léon BERARD — Lyon, France
- Hospices Civils de Lyon — Lyon, France
- Institut Paoli Calmettes — Marseille, France
- Institut régional du Cancer de Montpellier - ICM Val d'Aurelle — Montpellier, France
- Centre Antoine Lacassagne — Nice, France
- HEGP- Hôpital Européen Georges Pompidou — Paris, France
- Centre eugenie Marquis — Rennes, France
- Hopital Foch — Suresnes, France
- Gustave Roussy — Villejuif, France
- Hospital Universitari Vall d'Hebron — Barcelona, Spain
- Institut Catala d Oncologia - L Hospitalet de Llobregat — Barcelona, Spain
- Hospital Provincial de Castellon — Castellana, Spain
- Hospital Universitario Ramon y Cajal — Madrid, Spain
Full record on ClinicalTrials.gov
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