Study of Lenvatinib (E7080) in Participants With Advanced Hepatocellular Carcinoma (HCC)
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ClinicalTrials.gov Identifier: NCT00946153 |
Recruitment Status :
Completed
First Posted : July 24, 2009
Results First Posted : February 1, 2019
Last Update Posted : February 1, 2019
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Sponsor:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
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Tracking Information | |||
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First Submitted Date ICMJE | July 23, 2009 | ||
First Posted Date ICMJE | July 24, 2009 | ||
Results First Submitted Date ICMJE | August 27, 2018 | ||
Results First Posted Date ICMJE | February 1, 2019 | ||
Last Update Posted Date | February 1, 2019 | ||
Actual Study Start Date ICMJE | July 24, 2009 | ||
Actual Primary Completion Date | June 15, 2014 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Study of Lenvatinib (E7080) in Participants With Advanced Hepatocellular Carcinoma (HCC) | ||
Official Title ICMJE | Phase I/II Study of E7080 in Patients With Advanced Hepatocellular Carcinoma (HCC) | ||
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 participants with advanced hepatocellular carcinoma. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hepatocellular Carcinoma | ||
Intervention ICMJE | Drug: Lenvatinib
In the Dose-Escalation Component of the study, lenvatinib 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.
Other Name: E7080
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Study Arms ICMJE | Experimental: Lenvatinib
Intervention: Drug: Lenvatinib
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Publications * | Ikeda K, Kudo M, Kawazoe S, Osaki Y, Ikeda M, Okusaka T, Tamai T, Suzuki T, Hisai T, Hayato S, Okita K, Kumada H. Phase 2 study of lenvatinib in patients with advanced hepatocellular carcinoma. J Gastroenterol. 2017 Apr;52(4):512-519. doi: 10.1007/s00535-016-1263-4. Epub 2016 Oct 4. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
66 | ||
Original Estimated Enrollment ICMJE |
82 | ||
Actual Study Completion Date ICMJE | August 13, 2015 | ||
Actual Primary Completion Date | June 15, 2014 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 80 Years (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Japan, Korea, Republic of | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00946153 | ||
Other Study ID Numbers ICMJE | E7080-J081-202 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Eisai Inc. ( Eisai Co., Ltd. ) | ||
Study Sponsor ICMJE | Eisai Co., Ltd. | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Eisai Inc. | ||
Verification Date | July 2018 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |