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Phase I/II Study of E7080 in Patients With Advanced Hepatocellular Carcinoma (HCC)


Phase 1/Phase 2
20 Years
80 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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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

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