Spots Global Cancer Trial Database for Study of TAS3681 in Metastatic Castration Resistant Prostate Cancer
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Trial Identification
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
Study ID: NCT02566772
Interventions
Study Description
Brief 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).
Detailed 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 Closed). Patients who are continuing to receive clinical benefit may receive drug in the extension part of the study after escalation and expansion are completed.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
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
Montefiore Medical Center, Bronx, New York, United States
MSKCC, New York, 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 Cedex, , 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
Hospital 12 de Octubre, Madrid, , Spain
Hospital Universitari Parc Taulí, Sabadell, , Spain
Hospital Marques de Valdecilla, Santander, , Spain
Sarah Cannon Research Institute UK, London, England, United Kingdom
The Christie NHS Foundation Trust- The Christie Clinic, Manchester, Greater Manchester, United Kingdom
Royal Marsden Hospital (RMH) NHS Foundation Trust (DDU), Sutton, Surrey, United Kingdom
Royal Marsden Hospital (RMH) NHS Foundation Trust, Sutton, Surrey, United Kingdom
Cambridge University Hospitals NHS Foundation, Cambridge, , United Kingdom
Contact Details
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