Last updated on July 2017

Safety and Tolerability Study in Solid Tumors


Brief description of study

This is an open-label, multicenter, sequential dose-escalation, and expansion study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics 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 A will consist of between 12 to 48 participants. 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. Part B will consist of between 115 to 295 participants. Please note the study is currently only recruiting in the breast cancer cohorts.

Clinical Study Identifier: NCT01803282

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Alabama Oncology
Birmingham, AL United States
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Michael Gordon, MD

Pinnacle Oncology Hematology
Scottsdale, AZ United States
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Ravindranath Patel, MD

Comprehensive Blood and Cancer Center
Bakersfield, CA United States
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Alberto Bessudo, MD

San Diego Pacific Oncology and Hematology Associates, Inc.
Encinitas, CA United States
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Steven Hager, MD

Cancer Care Associates Of Fresno
Fresno, CA United States
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Heinz-Josef Lenz, MD

University of Southern California (USC)
Los Angeles, CA United States
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Ari Baron, MD

California Pacific Medical Center
San Francisco, CA United States
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Zev Wainberg, MD

UCLA Medical Center
Santa Monica, CA United States
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Manish Patel, MD

Florida Cancer Specialists
Sarasota, FL United States
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Alexander Starodub, MD

Parkview Research Center
Fort Wayne, IN United States
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Daniel Bruetman, MD

Indiana University Health Goshen Center for Cancer Care
Goshen, IN United States
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Paula Rosenblatt, MD

University of Maryland Medical Center
Baltimore, MD United States
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Haeseong Park, MD

Washington University School of Medicine
Saint Louis, MO United States
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Manish Shah, MD

Cornell University
New York, NY United States
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Nashat Gabrail, MD

Gabrail Cancer Center Research
Canton, OH United States
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Ki Chung, MD

Greenville Health System, Institute for Translational Oncology Research
Greenville, SC United States
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Johanna Bendell, MD

Sarah Cannon Research Institute
Nashville, TN United States
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Jordan Berlin, MD

Vanderbilt
Nashville, TN United States
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Saad Khan, MD

UT Southwestern
Dallas, TX United States
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University of Utah
Salt Lake City, UT United States
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Jorge Chaves, MD

Northwest Medical Specialties
Tacoma, WA United States
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