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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)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Hepatocellular Carcinoma

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Jacqueline Whang-Peng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Health Research Institute, Ward Veterans General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

AHX-03-103

NCT ID:

NCT00319683

Start Date:

Completion Date:

Related Keywords:

  • Hepatocellular Carcinoma
  • Cancer
  • Tumors
  • Neoplasms
  • Anticarcinogenic Agents
  • Antineoplastic Agents
  • Dihydrouracil Dehydrogenase (NADP)
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location

Queens Medical CenterHonolulu, Hawaii  96813