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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)

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00264446
Enrollment
Unknown
Registered
2005-12-13
Start date
Unknown
Completion date
Unknown
Last updated
2007-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

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

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.

Interventions

DRUGADH300004

Sponsors

Adherex Technologies, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026