NCT00946153

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_1 hepatocellular-carcinoma

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

July 24, 2009

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2015

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

February 1, 2019

Completed
Last Updated

February 1, 2019

Status Verified

July 1, 2018

Enrollment Period

4.9 years

First QC Date

July 23, 2009

Results QC Date

August 27, 2018

Last Update Submit

August 27, 2018

Conditions

Hepatocellular Carcinoma

Keywords

CarcinomaHepatocellular

Outcome Measures

Primary Outcomes (2)

  • Phase 1: Maximum Tolerated Dose (MTD) of Lenvatinib

    The MTD was defined as the highest dose level at which no more than 1 of 6 participants had a dose limiting toxicities (DLT). DLT was defined as any of the following events: grade 4 or higher hematologic toxicity or grade 3 thrombocytopenia that required blood transfusion, grade 3 or higher nonhematologic toxicity, grade 4 hypertension uncontrolled by antihypertensive drug(s), aspartate aminotransferase/alanine aminotransferase (AST/ALT) greater than (\>) 10.0\*upper limit of normal (ULN), proteinuria 4+ by urine dipstick, proteinuria 3+ by urine dipstick was to be monitored by 24-hour urine collection, proteinuria \>3.5 gram (g) for 24 hours, diarrhea/vomiting/nausea of grade 3 or higher that was uncontrollable despite maximal supportive therapies and abnormal clinical laboratory values that required no treatment, grade 3 proteinuria by dipstick, diarrhea/vomiting/nausea that was managed with supportive therapies were not considered as DLT.

    Up to 28 days (Cycle1)

  • Phase 2: Time to Progression (TTP) by Independent Review Assessment

    TTP was defined as the time from the date of registration to the date when progressive disease (PD) was first confirmed. PD was evaluated according to modified response evaluation criteria in solid tumors (mRECIST) by an independent imaging review. PD was defined as at least a 20 percent (%) increase in the sum of long diameter (LD) of target lesions as compared with the smallest sum of LD and the increase of LD was at least 5 millimeter (mm) (including new lesions).

    From day of registration to the day when PD was first confirmed (approximately up to 6.1 years)

Secondary Outcomes (7)

  • Phase 1: Best Overall Response (BOR) of Lenvatinib by Investigator Assessment

    Every 8 weeks (approximately up to 18.4 months)

  • Phase 1: Objective Response Rate (ORR) by Investigator Assessment

    From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)

  • Phase 1: Disease Control Rate (DCR) by Investigator Assessment

    Up to Week 16

  • Phase 2: Progression-free Survival (PFS) by Independent Review Assessment

    From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)

  • Phase 2: Objective Response Rate (ORR) by Independent Review Assessment

    From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)

  • +2 more secondary outcomes

Study Arms (1)

Lenvatinib

EXPERIMENTAL
Drug: Lenvatinib

Interventions

LenvatinibDRUG

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.

Also known as: E7080
Lenvatinib

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or clinically confirmed diagnosis of advanced HCC.
  • Eastern Cooperative Oncology Group-Performance Status (ECOG-PS): 0-1.
  • Adequate laboratory values/organ function tests.

You may not qualify if:

  • Simultaneous or metachronous cancers.
  • Pericardial, ascites, or pleural effusion requiring drainage.
  • Brain metastasis/meningeal carcinomatosis presenting clinical symptoms or requiring treatment.
  • Malabsorption syndrome.
  • Artery-portal vein shunt or artery-vein shunt preventing proper diagnosis of tumor.
  • Use of drugs known to inhibit cytochrome P3A4.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Kashiwa-shi, Chiba, Japan

Location

Unknown Facility

Kurume-shi, Fukuoka, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Kawasaki-shi, Kanagawa, Japan

Location

Unknown Facility

Osaka, Osaka, Japan

Location

Unknown Facility

Osakasayama-shi, Osaka, Japan

Location

Unknown Facility

Saga, Saga-ken, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, Japan

Location

Unknown Facility

Minato-ku, Tokyo, Japan

Location

Unknown Facility

Musashino-shi, Tokyo, Japan

Location

Unknown Facility

Gangnam-gu, Seoul, South Korea

Location

Unknown Facility

Songpa-gu, Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 27704266DERIVED

MeSH Terms

Conditions

Carcinoma, HepatocellularCarcinoma

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

AdenocarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Results Point of Contact

Title
Eisai Medical Services
Organization
Eisai, Inc.
esi_medinfo@eisai.com
1-888-422-4743

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 24, 2009

Study Start

July 24, 2009

Primary Completion

June 15, 2014

Study Completion

August 13, 2015

Last Updated

February 1, 2019

Results First Posted

February 1, 2019

Record last verified: 2018-07

Locations

KR(2)JP(10)