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

Tracking Information

First Received Date ^ICMJE

December 12, 2005

Last Updated Date

August 3, 2007

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00264446 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

Brief Summary

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment

Condition ^ICMJE

Neoplasms

Intervention ^ICMJE

Drug: ADH300004

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00264446

Responsible Party

Study ID Numbers ^ICMJE

Adherex Protocol # AHX-03-101

Study Sponsor ^ICMJE

Adherex Technologies, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Martin Heslin, MD

University of Alabama at Birmingham

Information Provided By

Adherex Technologies, Inc.

Verification Date

August 2007

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