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Endometrial CancerPhase 2NCT01111461

Study of Lenvatinib in Subjects With Advanced Endometrial Cancer and Disease Progression

A Phase 2 study testing Lenvatinib in people with Endometrial Cancer, run by Eisai Inc. at 78 sites in 8 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

To assess the objective response rate (ORR: complete response + partial response [CR+ PR]) of E7080 in subjects with unresectable endometrial cancer and disease progression following platinum-based, first-line chemotherapy. . Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
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
133 participants
Where
78 sitesin 8 countries
Study dates
Mar 2010to Oct 2015
Phase
Phase 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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of endometrial carcinoma.
  • Radiographic evidence of disease progression according to modified RECIST 1.1 after 1 prior systemic, platinum-based chemotherapy regimen for recurrent metastatic or primary unresectable endometrial carcinoma for which no surgical or radiotherapy treatment option exists.
  • Measureable disease meeting the following criteria:
  • At least 1 lesion of greater than 1.0 cm in the longest diameter for a non-lymph node or greater than 1.5 cm in the short-axis diameter for a lymph node which is serially measureable according to modified RECIST 1.1 using computerized tomography / magnetic resonance imaging.
  • Lesions that have had external beam radiotherapy (EBRT) or loco-regional therapies such as radiofrequency ablation must show evidence of progressive disease based on modified RECIST 1.1 to be deemed a target lesion.
  • Eastern Cooperative Oncology Group (ECOG) performance status less than 2.
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  • Adequate controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than 150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Screening Visit.
  • Adequate renal function defined as calculated creatinine clearance greater than 30 mL/min per the Cockcroft and Gault formula.
  • Adequate bone marrow, blood coagulation, and liver functions, as defined in the study protocol.
  • Negative serum or urine pregnancy test for women of reproductive potential.

Who cannot join

  • Brain or leptomeningeal metastases, including stable metastases.
  • More than 1 prior systemic chemotherapy regimen for recurrent metastatic or primary unresectable endometrial carcinoma or any treatment targeting vascular endothelial growth factor (VEGF)-directed angiogenesis. No restriction regarding prior adjuvant chemotherapy or hormonal therapy.
  • Prior systemic anti-tumor therapy within 3 weeks.
  • Not fully recovered from prior radiotherapy based on investigator judgement.
  • Participants with greater than 1+ proteinuria on urine dipstick testing to undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with greater than 1 gm will be ineligible.
  • Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association Class II; unstable angina; myocardial infarction or stroke within 6 months of the first dose of study drug; cardiac arrhythmia requiring medical treatment.
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  • Prolongation of QTc interval greater than 480 msec.
  • Bleeding disorder or thrombotic disorders requiring anticoagulant therapy, such as warfarin, or similar agents requiring therapeutic INR monitoring (treatment with low molecular weight heparin [LMWH] allowed).
  • Active hemoptysis within 3 weeks prior to the first dose of study drug.
  • Females who are pregnant or breast feeding.

Trial locations and contacts

78 sites in 8 countries.

78 sites in 8 countries

United States36 sites

  • Study site

    Arlington Heights, Illinois

  • Study site

    Austin, Texas

  • Study site

    Bedford, Texas

  • Study site

    Boston, Massachusetts

  • Study site

    Burnsville, Minnesota

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Charleston, South Carolina

  • Study site

    Cleveland, North Carolina

  • Study site

    Dallas, Texas

  • Study site

    Detroit, Michigan

  • Study site

    Durham, North Carolina

  • Study site

    Edina, Minnesota

  • Study site

    Eugene, Oregon

  • Study site

    Fort Worth, Texas

  • Study site

    Honolulu, Hawaii

  • Study site

    Los Angeles, California

  • Study site

    Maplewood, Minnesota

  • Study site

    Minneapolis, Minnesota

  • Study site

    Morristown, New Jersey

  • Study site

    New York, New York

  • Study site

    Newport News, Virginia

  • Study site

    Niles, Illinois

  • Study site

    Norfolk, Virginia

  • Study site

    Phoenix, Arizona

  • Study site

    Portland, Oregon

  • Study site

    Saint Paul, Minnesota

  • Study site

    Scottsdale, Arizona

  • Study site

    Springfield, Oregon

  • Study site

    St Louis, Missouri

  • Study site

    Tualatin, Oregon

  • Study site

    Tucson, Arizona

  • Study site

    Tyler, Texas

  • Study site

    Vancouver, Washington

  • Study site

    Virginia Beach, Virginia

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Woodbury, Minnesota

Other trials in United States

Russia12 sites

  • Study site

    Kazan'

  • Study site

    Nizhny Novgorod

  • Study site

    Orenburg

  • Study site

    Pyatigorsk

  • Study site

    Saint Petersburg

  • Study site

    Sochi

  • Study site

    Stavropol

  • Study site

    Syktyvkar

  • Study site

    Tomsk

  • Study site

    Tula

  • Study site

    Ufa

  • Study site

    Vladivostok

Other trials in Russia

Belgium11 sites

  • Study site

    Arlon

  • Study site

    Charleroi

  • Study site

    Duffel

  • Study site

    Ghent

  • Study site

    Kortrijk

  • Study site

    Leuven

  • Study site

    Liège

  • Study site

    Namur

  • Study site

    Ostend

  • Study site

    Roeselare

  • Study site

    Yvoir

Other trials in Belgium

Bulgaria5 sites

  • Study site

    Pleven

  • Study site

    Plovdiv

  • Study site

    Sofia

  • Study site

    Varna

  • Study site

    Veliko Tarnovo

Other trials in Bulgaria

Ukraine5 sites

  • Study site

    Chernihiv

  • Study site

    Donetsk

  • Study site

    Kharkiv

  • Study site

    Kyiv

  • Study site

    Zaporizhia

Other trials in Ukraine

Romania4 sites

  • Study site

    Brasov County

  • Study site

    Bucharest

  • Study site

    Cluj County

  • Study site

    Dolj County

Other trials in Romania

Poland3 sites

  • Study site

    Lublin

  • Study site

    Poznan

  • Study site

    Warsaw

Other trials in Poland

Hungary2 sites

  • Study site

    Budapest

  • Study site

    Győr

Other trials in Hungary

About this study

Official title: An Open-Label, Single-Arm, Multicenter Phase II Study of E7080 (Lenvatinib) in Subjects With Advanced Endometrial Cancer and Disease Progression Following First-Line Chemotherapy

To assess the objective response rate (ORR: complete response + partial response [CR+ PR]) of E7080 in subjects with unresectable endometrial cancer and disease progression following platinum-based, first-line chemotherapy. .

Being tested
Lenvatinib
Keywords
Advanced Endometrial Cancer
Medical subject headings
Endometrial Neoplasms

What participants receive

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

  • LenvatinibDrug

    Also called E7080, Lenvima

    Lenvatinib 24 mg administered orally, once daily continuously in 28-day cycles to participants with advanced endometrial cancer and disease progression following first-line chemotherapy. Participants continued to receive study drug until disease progression, development of unacceptable toxicity or withdrawal of consent. 'Treatment interruption and subsequent dose reduction' was allowed for participants who experienced lenvatinib-related toxicity.

Study groups in NCT01111461
Study groupRoleWhat they receive
Lenvatinib 24 mgExperimentalParticipants with advanced endometrial cancer and disease progression following platinum-based, first line chemotherapy.
Receives: Drug: Lenvatinib

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for target lesions assessed by magnetic resonance imaging/computed tomography (MRI/CT) scans, as determined by independent radiologic review. BOR of CR was confirmed by a subsequent CR assessment at least 4 weeks later. BOR of PR was confirmed by a subsequent CR or PR assessment at least 4 weeks later. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to <10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. The null hypothesis ORR was ≤10% was tested using 1-sided exact test of a single proportion, at 1-sided 0.05 level. ORR was presented with corresponding 2-sided, 95% confidence interval (CI). ORR=CR+PR

    Measured: From the date of first administration of study treatment until all participants completed a minimum of 6 cycles (28-day cycles) or discontinued treatment prior to the end of Cycle 6 (as of 21 May 2012 data cut-off)

Secondary outcomes (5)

  1. Progression Free Survival (PFS)

    PFS was measured as the time from the date of first administration of study treatment until the date of first documentation of disease progression or date of death (whichever occurred first), as determined by independent radiologic review (IRR) and Investigator based on RECIST 1.1. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.

    Measured: From date of first administration of study treatment until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression or up to approximately 26 months (as of 21 May 2012 data cut-off)

  2. Overall Survival (OS)

    OS was the length time in months from the date of first treatment until the date of death from any cause. If death was not observed, OS was censored at the last known alive date or data cut-off. Additional survival follow-up data was collected for all participants who had not withdrawn consent and were alive at the time of the initial survival follow-up as of 26 Nov 2012 data cut-off. Participants who were lost to follow-up at the time of the initial assessment may have been contacted again at the investigator's discretion. Updated survival (based on 26 Nov 2012 cut-off) was derived for these participants if the contact was made successfully.

    Measured: From date of first administration of study treatment until the date of death, or up to approximately 32 months (as of 26 Nov 2012 data cut-off)

  3. Disease Control Rate (DCR)

    DCR was defined as the percentage of participants with BOR of CR or PR or stable disease (SD) based on RECIST 1.1 and SD lasting greater than or equal to 7 weeks, as determined by IRR and Investigator.

    Measured: From date of first administration of study treatment until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, or up to approximately 26 months (as of 21 May 2012 data cut-off)

  4. Clinical Benefit Rate (CBR)

    CBR was defined as the percentage of participants with BOR of CR or PR or durable stable disease (dSD) [CR + PR + dSD] based on RECIST 1.1. The dSD rate was defined as the percentage of participants with dSD (based on RECIST 1.1 and defined as SD lasting greater than or equal to 23 weeks), as determined by the IRR and Investigator.

    Measured: From date of first administration of study treatment until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, or up to approximately 26 months (as of 21 May 2012 data cut-off)

  5. Number of Participants With Adverse Events (AEs) /Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib Tolerability of Lenvatinib

    Safety was assessed by monitoring and recording all AEs and SAEs, regular monitoring of hematology, clinical chemistry, and urine values, regular measurement of vital signs, electrocardiograms (ECGs), and echocardiograms.

    Measured: From the administration of first dose up to 30 days after the last dose, or up to data cut-off (21 May 2012), or up to approximately 26 months.

Timeline

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

  1. First posted27 Apr 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionMay 2012
  4. Study completionOct 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01111461
Sponsor's protocol ID
E7080-G000-204
Status last verified
Nov 2016
First submitted
16 Apr 2010
Last updated
22 Jun 2023
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenvatinib in people with Endometrial Cancer, run by Eisai Inc. at 78 sites in 8 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 10 inclusion and 10 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Russia, Belgium, Bulgaria, Ukraine and 3 more countries. 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 phase mean?

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 18 Apr 2016). 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?

Objective Response Rate (ORR) (time frame: From the date of first administration of study treatment until all participants completed a minimum of 6 cycles (28-day cycles) or discontinued treatment prior to the end of Cycle 6 (as of 21 May 2012 data cut-off)). 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 NCT01111461.

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 22 Jun 2023.

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