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Hepatocellular CarcinomaPhase 1/2NCT00946153

Study of Lenvatinib (E7080) in Participants With Advanced Hepatocellular Carcinoma (HCC)

A Phase 1/2 study testing Lenvatinib in people with Hepatocellular Carcinoma, run by Eisai Co., Ltd. at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Lenvatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
12 sitesin 2 countries
Study dates
24 Jul 2009to 13 Aug 2015
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

Japan10 sites

  • Study site

    Chuo-ku, Tokyo

  • Study site

    Kashiwa-shi, Chiba

  • Study site

    Kawasaki-shi, Kanagawa

  • Study site

    Kurume-shi, Fukuoka

  • Study site

    Minato-ku, Tokyo

  • Study site

    Musashino-shi, Tokyo

  • Study site

    Osaka, Osaka

  • Study site

    Osakasayama-shi, Osaka

  • Study site

    Saga, Saga-ken

  • Study site

    Sapporo, Hokkaido

Other trials in Japan

South Korea2 sites

  • Study site

    Gangnam-gu, Seoul

  • Study site

    Songpa-gu, Seoul

Other trials in South Korea

About this study

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

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.

Being tested
Lenvatinib
Keywords
Carcinoma, Hepatocellular
Medical subject headings
Carcinoma, Hepatocellular, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenvatinibDrug

    Also called E7080

    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.

Study groups in NCT00946153
Study groupRoleWhat they receive
LenvatinibExperimentalNot described
Receives: Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 28 days (Cycle1)

  2. 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).

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

Secondary outcomes (7)

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

    BOR was performed using RECIST1.1 and was measured as complete response (CR) defined as when an overall response of CR was obtained 2 or more consecutive times at intervals of at least 28 days (the date when the second overall response of CR was confirmed and the BOR established as CR was regarded as the "CR confirmed date), partial response (PR) defined as when the overall response of PR or better (CR or PR) was obtained 2 or more consecutive times at intervals of at least 28 days (the date when the second overall response of PR was confirmed and the BOR established as PR will be regarded as the "PR confirmed date), PD defined as when the BOR was neither CR, PR, or stable disease (SD), and the overall response was PD, SD defined as when the BOR obtained was neither CR nor PR, but no PD from the initial administration to the end of Cycle 2 and the overall response of SD or better occurred at least once and not evaluable (NE) was when the overall response was NE in all cases.

    Measured: Every 8 weeks (approximately up to 18.4 months)

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

    ORR was defined as the percentage of participants who achieved a tumor response measured by RECIST 1.1 of CR defined as disappearance of all target lesions (a short diameter is less than (<)10 mm if it exists in a lymph node) plus PR defined as at least 30% decrease in the sum of the long diameter LD (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD.

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

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

    DCR was measured by RECIST 1.1 and defined as CR which was defined as disappearance of all target lesions (a short diameter was <10 mm if it exists in a lymph node) plus PR which was defined as at least 30% decrease in the sum of the long diameter (hereafter referred to as sum of LD) of all target lesions, as compared with baseline summed LD plus SD which was reduction in tumor volume of less than 50% or an increase in the volume of 1 or more measurable lesions of less than 25% without the appearance of any new lesions which was neither tumor shrinkage corresponding to PR nor tumor expansion corresponding to PD.

    Measured: Up to Week 16

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

    PFS was defined as the time from the date of registration until the date when PD was first confirmed or death (whichever occurred first) as determined by mRECIST and PD was defined as at least a 20% increase in the sum of long diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.

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

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

    ORR was defined as the percentage of participants who achieved a tumor response measured by mRECIST of CR defined as disappearance of all target lesions (a short diameter is <10 mm if it exists in a lymph node) plus PR defined as at least 30% decrease in the sum of the long diameter LD (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD.

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

  6. Phase 2: Disease Control Rate (DCR) by Independent Review Assessment

    DCR was measured by mRECIST and defined as CR which was defined as disappearance of all target lesions (a short diameter is <10 mm if it exists in a lymph node) plus PR which was defined as at least 30% decrease in the sum of the long diameter (hereafter referred to as sum of LD) of all target lesions, as compared with baseline summed LD plus SD which was reduction in tumor volume of less than 50% or an increase in the volume of 1 or more measurable lesions of less than 25% without the appearance of any new lesions which was neither tumor shrinkage corresponding to PR nor tumor expansion corresponding to PD.

    Measured: Weeks 8 and 16

  7. Phase 2: Overall Survival (OS)

    OS was defined as the time from the date of registration until the date of death.

    Measured: From day of registration to the day of death (approximately 6.1 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2009 (estimated)
  2. Study start24 Jul 2009
  3. Primary completion15 Jun 2014
  4. Study completion13 Aug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00946153
Sponsor's protocol ID
E7080-J081-202
Status last verified
Jul 2018
First submitted
23 Jul 2009
Last updated
1 Feb 2019

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.

    PubMed 27704266

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lenvatinib in people with Hepatocellular Carcinoma, run by Eisai Co., Ltd. at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Maximum Tolerated Dose (MTD) of Lenvatinib (time frame: Up to 28 days (Cycle1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00946153, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.

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