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Study of E7080 in Patients With Advanced Hepatocellular Carcinoma (HCC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT00946153
First received: July 23, 2009
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to determine maximum tolerated dose (MTD), efficacy, safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 when is administered continually once daily in patients with advanced hepatocellular carcinoma.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: E7080
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of E7080 in Patients With Advanced Hepatocellular Carcinoma (HCC)

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Expansion Component: Time to progression. [ Time Frame: From day of registration to the day when progressive disease is first confirmed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dose-Escalation Component: To evaluate the anti-tumor effect of E7080 using Response Evaluation Criteria in Solid Tumors (RECIST). [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • Expansion Component: Progression-free survival. [ Time Frame: From day of registration to the day when progressive disease is first confirmed or death ] [ Designated as safety issue: No ]
  • Expansion Component: Objective response rate. [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • Expansion Component: Disease control rate. [ Time Frame: At 8 weeks and 16 weeks ] [ Designated as safety issue: No ]
  • Expansion Component: Overall survival. [ Time Frame: From day of registration to the day of death ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: July 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: E7080
In the Dose-Escalation Component of the study, E7080 will be administered as continuous once-daily oral dosing. Dose-escalation will occur based on safety information obtained during Cycle 1. The recommended dose for the Expansion Component of the study will use the MTD in Cycle 1.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946153

Locations
Japan
Kashiwa-shi, Chiba, Japan
Kurume-shi, Fukuoka, Japan
Sapporo-shi, Hokkaido, Japan
Kawasaki-shi, Kanagawa, Japan
Osaka-shi, Osaka, Japan
Osakasayama-shi, Osaka, Japan
Saga-shi, Saga, Japan
Chuo-ku, Tokyo, Japan
Minato-ku, Tokyo, Japan
Musashino-shi, Tokyo, Japan
Korea, Republic of
Gangnam-gu, Seoul, Korea, Republic of
Songpa-gu, Seoul, Korea, Republic of
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Takuya Suzuki Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT00946153     History of Changes
Other Study ID Numbers: E7080-J081-202
Study First Received: July 23, 2009
Last Updated: February 20, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Carcinoma
Hepatocellular

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 20, 2014