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

• Status: Suspended
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adherex Technologies, Inc.
• Treatments: Eniluracil; Fluorouracil

Criteria

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