A Study of ADH300004 and 5-Fluorouracil in Locally Advanced, Recurrent, or Metastatic Hepatocellular Carcinoma

• Status: Terminated
• 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 locally advanced, recurrent, or metastatic hepatocellular carcinoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Signed written informed consent

• In the Phase I portion, Asian subjects that are > or = to 18 years of age

• In the Phase II portion, any subjects that are > or = to 18 years of age

• Non-resectable locally advanced, recurrent, or metastatic hepatocellular carcinoma (HCC) that is either histologically proven or a radiologically documented liver mass with: (alpha-fetoprotein [AFP] > 4,000 ng/mL, hepatitis B surface antigen positive or alpha-fetoprotein [AFP] > 400 ng/mL, hepatitis B surface antigen negative)

• 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:

• Chemotherapy, radiotherapy, or any other investigational drug within 28 days prior to study entry

• No more than 1 previous treatment with systemic chemotherapy (chemotherapy administered as part of a chemo-embolization procedure is not considered systemic chemotherapy)

• 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