A Study of 5 Fluorouracil and the Anti-Tumor Activity of ADH300004 and 5 Fluorouracil in Subjects With Incurable Solid Tumors

Phase 1

Suspended

• Conditions: Neoplasms

• Registration Number: NCT00264472
• Lead Sponsor: Adherex Technologies, Inc.

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 test the safety and effects of oral ADH300004 14 hours prior to oral 5 FU in subjects with refractory solid tumors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-12-12
• Study First Submitted QC: 2005-12-12
• Study First Posted: 2005-12-13
• Study Start: 2006-01
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-12
• Last Update Posted: 2008-12-15
• Primary Completion: 2009-06

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Signed written informed consent
• > or = 18 years of age
• Advanced or metastatic solid tumors:

Part 1: Histologically proven advanced or metastatic solid tumors refractory to standard therapy or for which no standard therapy exists

Part 2: Histologically proven advanced and/or metastatic solid tumor of one of the following 6 histologies, that is refractory to standard curative therapy or for which no curative therapy exists: HCC, NSCLC, gastric cancer, cervical cancer, prostate cancer, and breast cancer

• Radiologically documented measurable or evaluable (non-measurable) disease
• Adequate performance status and organ function, as evidenced by hematologic and biochemical blood testing
• Willing to not receive fluoropyrimidine containing chemotherapy for 8 weeks after the last dose of ADH300004 in this study

Exclusion Criteria

• Cytotoxic chemotherapy, radiotherapy, or investigational drug within 28 days prior to study entry
• Non-cytotoxic cancer therapy within 14 days prior to study entry
• Portal hypertension with bleeding esophageal or gastric varices within the past 3 months
• Ascites that is refractory to conservative management
• Inability to take oral medication
• Active peptic ulcer disease
• Known hypersensitivity to 5-FU or ADH300004
• Stroke, major surgery, or other major tissue injury within 30 days before study entry

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Part 1: To determine the DLTs and MTD of the combination of ADH300004 and 5 FU administered orally in a weekly regimen, for 3 weeks with 1 week rest per cycle, in subjects with incurable solid tumors	4 weeks
Part 2: To determine the DLTs and MTD of the combination of ADH300004 and 5-FU administered orally as a split dose for 3 out of 4 weeks in subjects with HCC, NSCLC, gastric cancer, cervical cancer, prostate cancer, and breast cancer	4 weeks

Trial Locations

Locations (1)

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States