Spots Global Cancer Trial Database for Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer
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Trial Identification
Brief Title: Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer
Official Title: A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancer
Study ID: NCT01631552
Conditions
Interventions
Study Description
Brief Summary: The primary objective in Phase I is to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent administered in 21-day treatment cycles in previously treated participants with advanced epithelial cancer. In Phase II, the primary objective is to evaluate the safety and efficacy of sacituzumab govitecan-hziy administered in 21-day treatment cycles at a dose selected in Phase I. Tumor types in the study will include: cervical, colorectal, endometrial, ovarian, esophageal, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular, prostate, non-small-cell lung cancer, pancreatic, renal cell, small-cell lung cancer, non-triple negative breast cancer (non-TNBC), triple-negative breast cancer (TNBC) and metastatic urothelial cancer (mUC).
Detailed Description: The outcome measures are planned to be assessed up to the data cutoff date. Following the data cutoff date, the participants will either stay on the study and will be followed for safety data collection or rolled into another Gilead-sponsored study. Therefore, only safety data will be collected after the data cutoff date.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
Yale University School of Medicine, New Haven, Connecticut, United States
Helen F. Graham Cancer Center, Newark, Delaware, United States
MD Anderson Cancer Center Orlando (UF Health Cancer Center), Orlando, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
IU Health Goshen Cancer Center, Goshen, Indiana, United States
Massachusettes General Hospital, Boston, Massachusetts, United States
Weill Cornell/New York Presbyterian Hospital, New York, New York, United States
Columbia University Herbert Irving Cancer Center, New York, New York, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Texas Oncology Sammons Cancer Center, Dallas, Texas, United States
Virginia Mason Cancer Center, Seattle, Washington, United States
Contact Details
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR
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