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Completed

NCT Number: NCT00264446

A Study of ADH300004 in Surgically Resected Primary or Metastatic Colorectal Cancer and Liver Biopsy, or Planned Hepatic Resection

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.

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Key information

Conditions

Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Neoplasms by Site Rectal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UAB - Division of Surgery

Birmingham, Alabama, 35294-3300, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed written informed consent
  • > or = 19 years of age
  • Patients with histologically confirmed:
  • primary or metastatic (known or suspected) colorectal carcinoma requiring planned surgical resection with hepatic biopsy and systemic chemotherapy , or
  • primary or metastatic neoplastic disease within the liver from any origin requiring planned surgical resection and systemic chemotherapy
  • Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing

Exclusion criteria

  • Lack of known or suspected metastatic disease in the liver
  • Known DPD deficiency
  • Severe infection
  • Inability to take oral medication
  • The need for treatment with any fluoropyrimidine within 8 weeks of any ADH300004 dose
  • Stroke, major surgery, or other major tissue injury within 30 days before study entry

Treatment and study plan

ADH300004

Drug

Sponsors and collaborators

Lead sponsor

Adherex Technologies, Inc.

Industry

Registry information

Official study 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)

Important dates

First posted
Dec 13, 2005
Registry last updated
Aug 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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