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

This study has been completed.
Sponsor:
Information provided by:
Adherex Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00264446
First received: December 12, 2005
Last updated: August 3, 2007
Last verified: August 2007
History of Changes

December 12, 2005
August 3, 2007
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Complete list of historical versions of study NCT00264446 on ClinicalTrials.gov Archive Site
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A Study of ADH300004 in Surgically Resected Primary or Metastatic Colorectal Cancer and Liver Biopsy, or Planned Hepatic Resection
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)

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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Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
Drug: ADH300004
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00264446
Adherex Protocol # AHX-03-101
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Adherex Technologies, Inc.
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Principal Investigator: Martin Heslin, MD University of Alabama at Birmingham
Adherex Technologies, Inc.
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP