Status:
SUSPENDED
A Study of 5 Fluorouracil and the Anti-Tumor Activity of ADH300004 and 5 Fluorouracil in Subjects With Incurable Solid Tumors
Lead Sponsor:
Adherex Technologies, Inc.
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00264472
Start Date
January 1 2006
Last Update
December 15 2008
Active Locations (1)
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1
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203