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.

Condition	Intervention	Phase
Neoplasms	Drug: ADH300004	Phase I

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Signed written informed consent

• > or = 18 years of age

• Histologically proven advanced or metastatic solid tumors that are refractory to standard therapy or for which no standard therapy exists

• Radiologically documented 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

• History of primary brain tumors or brain metastases

• Previous or concurrent malignancy at another site within the last 5 years

• Stroke, major surgery, or other major tissue injury within 30 days before study entry

Please refer to this study by ClinicalTrials.gov identifier  NCT00264472

Tennessee
      Sarah Cannon Research Institute, Nashville,  Tennessee,  37203,  United States

Study chairs or principal investigators

Howard Burris, III, MD,  Principal Investigator,  Sarah Cannon Research Institute   

Study ID Numbers:  Adherex Protocol # AHX-03-104
Last Updated:  December 12, 2005
Record first received:  December 12, 2005
ClinicalTrials.gov Identifier:  NCT00264472
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10