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

Back to results

Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ADH300004

About this trial

This is an interventional treatment trial for Neoplasms focused on measuring Cancer; Tumors; Neoplasms; Anticarcinogenic Agents; Antineoplastic Agents;, Dihydrouracil dehydrogenase (NADP); Colorectal Carcinoma; Liver Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

UAB - Division of Surgery

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00264446

First Posted

December 12, 2005

Last Updated

August 3, 2007

Sponsor

Adherex Technologies, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00264446

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2007

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Adherex Technologies, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasms

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

ADH300004

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Heslin, MD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

UAB - Division of Surgery

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294-3300

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.adherex.com

Description

Adherex Technologies Inc. Corporate Homepage

Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial