A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous XMT-1001 in Patients With Advanced Solid Tumors
This is an open-label study of XMT-1001 administered intravenously over 4 hours every 21
days (1 Cycle). Blood sampling for PK analyses will be performed immediately prior to
dosing, and 9 times after dosing. Patients will be assessed for toxicities known to occur
with other drugs of this class, such as bone marrow suppression, elevated liver function
enzymes, hemorrhagic cystitis, and diarrhea. Tumor imaging will be performed every 2 cycles.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical laboratory examinations: complete blood count (CBC) with differential, liver function tests, coagulation tests, serum chemistry, urinalysis
At baseline, 8, 15, and 21 days post dosing
Yes
Edward Sausville, MD
Principal Investigator
University of Maryland Greenebaum Cancer Center
United States: Food and Drug Administration
MER-001
NCT00455052
March 2011
June 2013
Name | Location |
---|---|
Virginia Oncology Associates | Newport News, Virginia 23606 |
Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
Rocky Mountain Cancer Centers | Thornton, Colorado 80260 |
University of Maryland, Greenebaum Cancer Center | Baltimore, Maryland 21201 |
Central Indiana Cancer Centers | Indianapolis, Indiana 46227 |
New York Oncology Hematology | Albany, New York 12208 |
TGen Clinical Research Services at Scottsdale Healthcare | Scottsdale, Arizona 85258 |
Willamette Valley Cancer Institute and Research Center | Springfield, Oregon 97477 |
Institute of Translational Oncology Research | Greenville, South Carolina 29605 |
Texas Oncology - Tyler | Tyler, Texas 75702 |
Evergreen Hematology & Oncology | Spokane, Washington 99218 |
Vancouver Cancer Center | Vancouver, Washington 98684 |