Trial Information
Phase I/II Study of E7080 in Patients With Advanced Hepatocellular Carcinoma (HCC)
Inclusion Criteria
Inclusion criteria:
1. Histologically or clinically confirmed diagnosis of advanced HCC
2. Eastern Cooperative Oncology Group-Performance Status (ECOG-PS): 0-1
3. Adequate laboratory values/organ function tests
Exclusion criteria:
1. Simultaneous or metachronous cancers
2. Pericardial, ascites, or pleural effusion requiring drainage
3. Brain metastasis/meningeal carcinomatosis presenting clinical symptoms or requiring
treatment
4. Malabsorption syndrome
5. Artery-portal vein shunt or artery-vein shunt preventing proper diagnosis of tumor
6. Use of drugs known to inhibit cytochrome P3A4
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Dose-Escalation Component: To determine the MTD defined by dose-limiting toxicity (DLT) of E7080. Safety assessments based on adverse events, physical exams, and selected lab values.
Outcome Time Frame:
4 weeks
Safety Issue:
Yes
Principal Investigator
Takuya Suzuki
Investigator Role:
Study Director
Investigator Affiliation:
Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
E7080-J081-202
NCT ID:
NCT00946153
Start Date:
August 2009
Completion Date:
March 2013
Related Keywords:
- Hepatocellular Carcinoma
- Carcinoma
- Hepatocellular
- Carcinoma
- Carcinoma, Hepatocellular