Brief Title
Study of Lenvatinib in Subjects With Advanced Endometrial Cancer and Disease Progression
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
Brief 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. .
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective Response Rate (ORR)
Secondary Outcome
Progression Free Survival (PFS)
Condition
Endometrial Cancer
Intervention
Lenvatinib
Study Arms / Comparison Groups
Lenvatinib 24 mg
Description: Participants with advanced endometrial cancer and disease progression following platinum-based, first line chemotherapy.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
133
Start Date
March 2010
Completion Date
October 2015
Primary Completion Date
May 2012
Eligibility Criteria
Inclusion criteria:
1. Histologically confirmed diagnosis of endometrial carcinoma.
2. 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.
3. 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.
4. Eastern Cooperative Oncology Group (ECOG) performance status less than 2.
5. 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.
6. Adequate renal function defined as calculated creatinine clearance greater than 30
mL/min per the Cockcroft and Gault formula.
7. Adequate bone marrow, blood coagulation, and liver functions, as defined in the study
protocol.
8. Negative serum or urine pregnancy test for women of reproductive potential.
Exclusion criteria:
1. Brain or leptomeningeal metastases, including stable metastases.
2. 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.
3. Prior systemic anti-tumor therapy within 3 weeks.
4. Not fully recovered from prior radiotherapy based on investigator judgement.
5. 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.
6. 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.
7. Prolongation of QTc interval greater than 480 msec.
8. 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).
9. Active hemoptysis within 3 weeks prior to the first dose of study drug.
10. Females who are pregnant or breast feeding.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Eisai Medical Services, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT01111461
Organization ID
E7080-G000-204
Responsible Party
Sponsor
Study Sponsor
Eisai Inc.
Study Sponsor
Eisai Medical Services, Study Director, Eisai Limited
Verification Date
November 2016