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Brief Title: DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)
Official Title: A Phase 2, Open-label, Single-arm Trial of Trastuzumab Deruxtecan (DS 8201a) in HER2-positive, Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma Subjects Who Have Progressed on or After a Trastuzumab-containing Regimen (DESTINY-Gastric02)
Study ID: NCT04014075
Brief Summary: This study will find out if trastuzumab deruxtecan is safe and works for participants with gastric or gastroesophageal junction cancer. They must have human epidermal growth factor receptor 2 (HER2)-positive gastric or gastro-esophageal junction (GEJ) cancer: * that cannot be removed surgically * that has moved to other parts of the body * that got worse during or after treatment that included trastuzumab The study will enroll about 80 participants. Sites will be in North America and the European Union.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope Medical Center, Duarte, California, United States
USC Norris Comprehensive Cancer Center Hospital, Los Angeles, California, United States
Pacific Cancer Care, Monterey, California, United States
UCLA Health, Santa Monica, California, United States
Hartford Hospital, Hartford, Connecticut, United States
MidState Medical Center, Meriden, Connecticut, United States
The Hospital of Central Connecticut, New Britain, Connecticut, United States
Smilow Cancer Hospital at Yale-New Haven, New Haven, Connecticut, United States
Miami Cancer Institute, Baptist Health South Florida, Miami, Florida, United States
University of Chicago Medical Center UCMC Duchossois Center for Advanced Medicine DCAM, Chicago, Illinois, United States
Kansas University Cancer Center, Kansas City, Kansas, United States
Massachusetts General Hospital (MGH), Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (BIDMC), Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Alvin J. Siteman Cancer Center Washington University, Saint Louis, Missouri, United States
Northwell Health Cancer Institute, Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Lehigh Valley Health Network, Allentown, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
University of Washington/Seattle Cancer Care Alliance, Seattle, Washington, United States
UCL St-Luc, Brussels, , Belgium
Hopital de Jolimont, Haine-Saint-Paul, , Belgium
UZ Leuven, Leuven, , Belgium
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Asst Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Azienda Ospedaliero Universitaria di Modena Policlinico, Modena, , Italy
Oncology Institute Veneto IOVIRCCS, Padua, , Italy
Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Institut Catalan de Oncologia Hospital Duran i Reynals, Barcelona, , Spain
Hospital la Paz, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Biomedical Research Institute Hospital de Valencia, Valencia, , Spain
Cambridge University Hospitals NHS Foundation Trust, Cambridge, , United Kingdom
The Royal Marsden Hospital, London, , United Kingdom
Christie Hospital, Manchester, , United Kingdom
The Royal Marsden Hospital, Sutton, , United Kingdom
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR