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

Adherex Technologies

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Hepatocellular Carcinoma

Treatments

Drug: ADH300004

Study type

Interventional

Funder types

Industry

Identifiers

NCT00319683

AHX-03-103

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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