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

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ClinicalTrials.gov Identifier: NCT00946153
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : June 22, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: E7080 Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of E7080 in Patients With Advanced Hepatocellular Carcinoma (HCC)
Study Start Date : July 2009
Primary Completion Date : June 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Lenvatinib
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. Expansion Component: Time to progression. [ Time Frame: From day of registration to the day when progressive disease is first confirmed ]

Secondary Outcome Measures :
  1. Dose-Escalation Component: To evaluate the anti-tumor effect of E7080 using Response Evaluation Criteria in Solid Tumors (RECIST). [ Time Frame: Every 8 weeks ]
  2. Expansion Component: Progression-free survival. [ Time Frame: From day of registration to the day when progressive disease is first confirmed or death ]
  3. Expansion Component: Objective response rate. [ Time Frame: Every 8 weeks ]
  4. Expansion Component: Disease control rate. [ Time Frame: At 8 weeks and 16 weeks ]
  5. Expansion Component: Overall survival. [ Time Frame: From day of registration to the day of death ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT00946153     History of Changes
Other Study ID Numbers: E7080-J081-202
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: June 22, 2015
Last Verified: June 2015

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Carcinoma
Hepatocellular

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Lenvatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action