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

Hepatocellular Carcinoma Clinical Trial

Official title:

A Phase 1/2 Study in Subjects With Locally Advanced, Recurrent, or Metastatic Hepatocellular Carcinoma, Evaluating the Safety, and Anti-Tumor Activity of ADH300004 (Eniluracil) With Escalating Doses of 5 Fluorouracil Administered Orally Once Weekly for 3 Weeks Out of Every 4 (Adherex Protocol Number AHX-03-103)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00319683
• Other study ID #: AHX-03-103
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: April 27, 2006
• Last updated: December 12, 2008

Study information

• Verified date: December 2008
• Source: Adherex Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSingapore: Health Sciences AuthorityTaiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• ADH300004

Locations

Country	Name	City	State
Singapore	Johns Hopkins Singapore International Medical Center	Singapore
Taiwan	Chang Gung Memorial Hospital	Chiayi
Taiwan	Chung-Ho Memorial Hospital, Kaohsiung Medical University	Kaohsiung
Taiwan	National Health Research Institute, Ward Veterans General Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
United States	Queens Medical Center	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Adherex Technologies, Inc.

Countries where clinical trial is conducted

United States,  Singapore,  Taiwan, 

External Links

•   Adherex Technologies Inc. Corporate Homepage