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Brief Title: A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of TH-302 in Patients With Advanced Solid Tumors
Official Title: A Phase I, Multi-Center, Open-Label, Dose-Escalation Study of the Safety, Pharmacokinetics and Anti-Tumor Activity of TH-302 in Patients With Advanced Solid Tumors
Study ID: NCT00495144
Brief Summary: This is a phase I, multi-center, open-label, dose-escalation study of TH-302 in patients with advanced solid tumors. TH-302 is a hypoxia activated product designed to exploit the hypoxic nature of tumors. The study is designed to establish the safety including the maximum tolerated dose, the pharmacokinetics, and the anti-tumor activity of TH-302.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
TGen Drug Development Services, Scottsdale, Arizona, United States
Mayo Clinic Arizona, Scottsdale, Arizona, United States
St. Mary's Medical Center, San Francisco, California, United States
Indiana University Simon Cancer Center, Indianapolis, Indiana, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Mary Crowley Cancer Research Centers, Dallas, Texas, United States
Name: Howard Burris, MD
Affiliation: SCRI Development Innovations, LLC
Role: PRINCIPAL_INVESTIGATOR
Name: Glen Weiss, MD
Affiliation: Translational Drug Development
Role: PRINCIPAL_INVESTIGATOR