Spots Global Cancer Trial Database for Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors
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Trial Identification
Brief Title: Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors
Official Title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5745 as Monotherapy and in Combination With Chemotherapy in Subjects With Advanced Solid Tumors
Study ID: NCT01803282
Study Description
Brief Summary: The primary objective of the study is to determine the maximum tolerated dose of andecaliximab monotherapy and to evaluate the safety and tolerability of andecaliximab (formerly GS-5745) alone and in combination with chemotherapy. The study consists of 2 parts (Parts A and B). Participants can only qualify for and participate in 1 part. Part A is a sequential dose escalation to determine the maximum tolerated dose of andecaliximab in participants with advanced solid tumors that are refractory to or intolerant to standard therapy or for which no standard therapy exists. In Part A, participants will receive andecaliximab only. Part B is a dose expansion to obtain additional safety and tolerability data for andecaliximab in participants with advanced pancreatic adenocarcinoma, lung adenocarcinoma, lung squamous cell carcinoma, esophagogastric adenocarcinoma, colorectal cancer, or breast cancer. In Part B, participants will receive andecaliximab in combination with standard-of-care chemotherapy.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alabama Oncology, Birmingham, Alabama, United States
Pinnacle Oncology Hematology, Scottsdale, Arizona, United States
Comprehensive Blood and Cancer Center, Bakersfield, California, United States
San Diego Pacific Oncology and Hematology Associates, Inc., Encinitas, California, United States
University of Southern California (USC), Los Angeles, California, United States
California Pacific Medical Center, San Francisco, California, United States
UCLA Medical Center, Santa Monica, California, United States
Florida Cancer Specialists, Sarasota, Florida, United States
Parkview Research Center, Fort Wayne, Indiana, United States
Indiana University Health Goshen Center for Cancer Care, Goshen, Indiana, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Cornell University, New York, New York, United States
Greenville Health System, Institute for Translational Oncology Research, Greenville, South Carolina, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Vanderbilt, Nashville, Tennessee, United States
UT Southwestern, Dallas, Texas, United States
University of Utah, Salt Lake City, Utah, United States
Northwest Medical Specialties, Tacoma, Washington, United States
Contact Details
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR
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