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

Status:

TERMINATED

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

Lead Sponsor:

Adherex Technologies, Inc.

Conditions:

Hepatocellular Carcinoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

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
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

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

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00319683

Last Update

December 15 2008

Active Locations (7)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (7 locations)

Queens Medical Center

Honolulu, Hawaii, United States, 96813

Johns Hopkins Singapore International Medical Center

Singapore, Singapore

Chang Gung Memorial Hospital

Chiayi City, Taiwan