Spots Global Cancer Trial Database for Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors
Official Title: A Phase 1 Open-Label, Dose-Finding Study Evaluating Safety and Pharmacokinetics of FPA144 in Patients With Advanced Solid Tumors
Study ID: NCT02318329
Interventions
Study Description
Brief Summary: This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both.
Detailed Description: Part 1A is a dose-escalation study in patients with any locally advanced or metastatic solid tumor or lymphoma for which standard therapies have been exhausted. Part 1B will further assess safety and evaluate PK of FPA144 in gastric cancer patients. Part 2 patients will be enrolled and treated in order to further characterize safety and preliminary efficacy in a selected cancer patient population with the greatest potential for clinical benefit from FPA144 treatment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, Mission Bay, San Francisco, California, United States
Innovative Cancer Research Institute, Whittier, California, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Weill Cornell Medical Center, New York, New York, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute, LLC, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
The University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
South Texas Accelerated Research Therapeutics, LLC, San Antonio, Texas, United States
Chonbuk National University Hospital, Jeonju, Jeollabuk-do, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Seoul, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
SMG-SNU Boramae Medical Center, Seoul, , Korea, Republic of
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Contact Details
Name: Medical Lead
Affiliation: Five Prime Therapeutics, Inc.
Role: STUDY_DIRECTOR
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