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

Adherex Technologies

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: ADH300004

Study type

Interventional

Funder types

Industry

Identifiers

NCT00264446

Adherex Protocol # AHX-03-101

Details and patient eligibility

About

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.

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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