AMP-005 is a Phase 1b/2 clinical trial designed to evaluate whether the new drug, imexon, can be administered in combination with the approved drug, dacarbazine (DTIC), for the treatment of patients with stage III or IV inoperable melanoma. The Phase 1b part of the study is designed to determine whether the two drugs can be safely combined together, and the Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether adding imexon to DTIC can improve the outcome for melanoma patients versus the findings from prior clinical studies of DTIC alone.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Investigational Site 009
Los Angeles, California, United States
Investigational Site 002
Santa Monica, California, United States
University of CO Anschutz Cancer Pavilion
Aurora, Colorado, United States
Determine the maximally tolerated dose of imexon plus DTIC
determine the toxicity and tolerability of the combination
determine response rate and progression free survival
Determine effects of the drug combination on plasma thiol levels and other biomarkers
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US Oncology Orlando, Cancer Centers of FL
Ocoee, Florida, United States
US Oncology Albany, New York Oncology
Albany, New York, United States
US Oncology Kettering
Kettering, Ohio, United States
US Oncology Greenville, Cancer Centers of the Carolinas
Greenville, South Carolina, United States
US Oncology, Tyler Cancer Center
Tyler, Texas, United States
Investigational Site 012
Salt Lake City, Utah, United States
US Oncology, Virginia Oncology Assoc
Norfolk, Virginia, United States
...and 1 more locations