Spots Global Cancer Trial Database for A Study of ADH300004 and 5-Fluorouracil in Locally Advanced, Recurrent, or Metastatic Hepatocellular Carcinoma
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Trial Identification
Brief Title: A Study of ADH300004 and 5-Fluorouracil in Locally Advanced, Recurrent, or Metastatic Hepatocellular Carcinoma
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)
Study ID: NCT00319683
Conditions
Interventions
Study Description
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 the safety and effects of oral ADH300004 14 hours prior to oral 5-FU in subjects with locally advanced, recurrent, or metastatic hepatocellular carcinoma.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Queens Medical Center, Honolulu, Hawaii, United States
Johns Hopkins Singapore International Medical Center, Singapore, , Singapore
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, , Taiwan
Contact Details
Name: Jacqueline Whang-Peng, MD
Affiliation: National Health Research Institute, Ward Veterans General Hospital
Role: PRINCIPAL_INVESTIGATOR
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