A Phase II, Open-Label, Multicenter Study of the GARFT Inhibitor AG2037 in Patients With Metastatic Colorectal Cancer Who Failed Treatment With a 5-Fluorouracil/Leucovorin Regimen
- Determine the overall objective response rate (complete and partial response) in
patients with metastatic adenocarcinoma of the colon or rectum that failed prior
fluorouracil and leucovorin calcium therapy and up to 1 other chemotherapy regimen (not
including adjuvant chemotherapy) when treated with AG2037.
- Determine time to progression in patients treated with this drug.
- Determine the safety of this drug in these patients.
- Determine the 1-year and overall survival of patients treated with this drug.
- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
- Determine changes in patient outcomes (e.g., symptoms, functioning, and quality of
life) in patients treated with this drug.
- Correlate various genetic markers of methylthioadenosine phosphorylase (MTAP), folate,
and purine metabolism with clinical response in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study.
Patients receive AG2037 IV over 15-30 minutes on days 1, 8, and 15. Courses repeat every 28
days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on day 1 of every course (beginning with course 2),
upon exit from the study, and then 30 days after the last treatment dose.
Patients are followed every 3 months for up to 1 year.
PROJECTED ACCRUAL: A total of 23-56 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Leonard B. Saltz, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University||Cleveland, Ohio 44106|
|Lombardi Cancer Center at Georgetown University Medical Center||Washington, District of Columbia 20007|
|H. Lee Moffitt Cancer Center and Research Institute at University of South Florida||Tampa, Florida 33612|
|Southwest Cancer Care - Poway||Poway, California 92064|