To determine the response rate in patients with metastatic colorectal cancer who failed treatment with a 5-Fluorouracil/Leucovorin regimen and up to one other chemotherapeutic regimen (not including adjuvant chemotherapy).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Pfizer Investigational Site
Poway, California, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
New York, New York, United States
To determine the overall objective response rate (complete and partial responses) of AG-2037 in patients with metastatic colorectal cancer who failed treatment with 5FU/LV regimen and up to one other chemotherapeutic regimen.
To estimate time to progression (TTP).
To evaluate the overall survival (1-year) of patients treated with AG-2037.
To assess changes in patient reported outcomes using health-related quality of life questionnaires.
To evaluate the safety of AG-2037.
To evalutate the PK and PD of AG-2037.
To correlate the various genetic markers of MTAP, folate and purine metabolism with clinical response.
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