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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00078468 |
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).
Condition | Intervention | Phase |
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Colorectal Neoplasms |
Drug: PELITREXOL/AG-2037 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Open-Label Multicenter Study Of The Garft Inhibitor AG2037 In Patients With Metastatic Colorectal Cancer Who Failed Treatment With A 5-Fluorouracil/Leucovorin Regimen. |
Estimated Enrollment: | 56 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | September 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
counted as a chemotherapeutic regimen unless used in combination with a cytotoxic regimen NOTE: *If evidence of failure occurred within < 6 months after completion of adjuvant therapy, patients may have received only 1 additional regimen for metastatic disease
Exclusion Criteria:
United States, California | |
Pfizer Investigational Site | |
Poway, California, United States, 92064 | |
United States, District of Columbia | |
Pfizer Investigational Site | |
Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
Pfizer Investigational Site | |
Tampa, Florida, United States, 33612 | |
United States, New York | |
Pfizer Investigational Site | |
New York, New York, United States, 10021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Study ID Numbers: | A4371004 |
Study First Received: | February 27, 2004 |
Last Updated: | November 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00078468 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Fluorouracil Colonic Diseases Leucovorin |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |