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Sponsored by: |
Adherex Technologies, Inc. |
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Information provided by: | Adherex Technologies, Inc. |
ClinicalTrials.gov Identifier: | NCT00264446 |
5 fluorouracil (5 FU), one of the most actively investigated anti-cancer drugs, is rapidly inactivated by the enzyme dihydropyrimidine dehydrogenase (DPD). ADH300004 blocks DPD. This study will examine the kinetics of inhibition and recovery of the metabolic pathways for fluoropyrimidines in subjects who receive a single oral dose of ADH300004, and may allow optimization of oral 5 FU dosing to subjects in future studies.
Condition | Intervention | Phase |
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Neoplasms |
Drug: ADH300004 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment |
Official Title: | Phase 1 Study of the Evaluation of Dihydropyrimidine Dehydrogenase (DPD), Uridine Phosphorylase (UP), Orotate Phosphoribosyl Transferase (OPRT), and Thymidine Phosphorylase (TP) Activity in Tissue Resected From Subjects Undergoing Planned Resection of Primary or Metastatic Colorectal Cancer and Liver Biopsy, or Planned Hepatic Resection, Following Administration of Oral ADH300004 (Adherex Protocol Number AHX-03-101) |
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with histologically confirmed:
Exclusion Criteria:
United States, Alabama | |
UAB - Division of Surgery | |
Birmingham, Alabama, United States, 35294-3300 |
Principal Investigator: | Martin Heslin, MD | University of Alabama at Birmingham |
Study ID Numbers: | Adherex Protocol # AHX-03-101 |
Study First Received: | December 12, 2005 |
Last Updated: | August 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00264446 |
Health Authority: | United States: Food and Drug Administration |
Cancer; Tumors; Neoplasms; Anticarcinogenic Agents; Antineoplastic Agents; Dihydrouracil dehydrogenase (NADP); Colorectal Carcinoma; Liver Cancer |
Dihydropyrimidine dehydrogenase deficiency Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases 5-ethynyluracil Liver neoplasms Dihydropyrimidine Dehydrogenase Deficiency Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Carcinoma Liver Neoplasms Digestive System Diseases Dihydrouracil Dehydrogenase (NADP) Gastrointestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Pharmacologic Actions |