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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ADH300004

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Martin Heslin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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UAB - Division of Surgery

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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Adherex Protocol # AHX-03-101

Identifier Type: -

Identifier Source: org_study_id