Study of Lenvatinib in Subjects With Advanced Endometrial Cancer and Disease Progression
NCT ID: NCT01111461
Last Updated: 2023-06-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
133 participants
INTERVENTIONAL
2010-03-31
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lenvatinib 24 mg
Participants with advanced endometrial cancer and disease progression following platinum-based, first line chemotherapy.
Lenvatinib
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.
Interventions
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Lenvatinib
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eisai Medical Services
Role: STUDY_DIRECTOR
Eisai Limited
Locations
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Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Los Angeles, California, United States
Honolulu, Hawaii, United States
Arlington Heights, Illinois, United States
Niles, Illinois, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Burnsville, Minnesota, United States
Edina, Minnesota, United States
Maplewood, Minnesota, United States
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
Woodbury, Minnesota, United States
St Louis, Missouri, United States
Morristown, New Jersey, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Cleveland, North Carolina, United States
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
Eugene, Oregon, United States
Portland, Oregon, United States
Springfield, Oregon, United States
Tualatin, Oregon, United States
Charleston, South Carolina, United States
Austin, Texas, United States
Bedford, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Tyler, Texas, United States
Newport News, Virginia, United States
Norfolk, Virginia, United States
Virginia Beach, Virginia, United States
Vancouver, Washington, United States
Arlon, , Belgium
Charleroi, , Belgium
Duffel, , Belgium
Ghent, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Liège, , Belgium
Namur, , Belgium
Ostend, , Belgium
Roeselare, , Belgium
Yvoir, , Belgium
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Veliko Tarnovo, , Bulgaria
Budapest, , Hungary
Győr, , Hungary
Lublin, , Poland
Poznan, , Poland
Warsaw, , Poland
Brasov County, , Romania
Bucharest, , Romania
Cluj County, , Romania
Dolj County, , Romania
Kazan', , Russia
Nizhny Novgorod, , Russia
Orenburg, , Russia
Pyatigorsk, , Russia
Saint Petersburg, , Russia
Sochi, , Russia
Stavropol, , Russia
Syktyvkar, , Russia
Tomsk, , Russia
Tula, , Russia
Ufa, , Russia
Vladivostok, , Russia
Chernihiv, , Ukraine
Donetsk, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Zaporizhia, , Ukraine
Countries
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Other Identifiers
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E7080-G000-204
Identifier Type: -
Identifier Source: org_study_id
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