NCT00264446

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2005

Completed
Last Updated

August 6, 2007

Status Verified

August 1, 2007

First QC Date

December 12, 2005

Last Update Submit

August 3, 2007

Conditions

Neoplasms

Keywords

Cancer; Tumors; Neoplasms; Anticarcinogenic Agents; Antineoplastic Agents;Dihydrouracil dehydrogenase (NADP); Colorectal Carcinoma; Liver Cancer

Interventions

ADH300004DRUG

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB - Division of Surgery

Birmingham, Alabama, 35294-3300, United States

Location

Related Links

MeSH Terms

Conditions

NeoplasmsColorectal NeoplasmsLiver Neoplasms

Interventions

eniluracil

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesLiver Diseases

Study Officials

  • Martin Heslin, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 12, 2005

First Posted

December 13, 2005

Last Updated

August 6, 2007

Record last verified: 2007-08

Locations

US(1)