A Study of E7080 in Subjects With Advanced Thyroid Cancer
NCT ID: NCT01728623
Last Updated: 2020-08-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
51 participants
INTERVENTIONAL
2012-09-03
2015-10-01
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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E7080
E7080 capsule
E7080 is administered as continuous once daily dosing in an uncontrolled manner
Interventions
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E7080 capsule
E7080 is administered as continuous once daily dosing in an uncontrolled manner
Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-2
3. Adequate laboratory values/organ function tests
Exclusion Criteria
1. Brain metastasis
2. Systemic severe infection
3. Significant cardiovascular impairment
4. QTc greater than 480 milliseconds
5. Active hemoptysis
6. Bleeding or thrombotic disorders
7. Having greater than 1+ proteinuria on urine dipstick testing will undergo 24 hour urine collection for quantitative assessment of proteinuria
8. Gastrointestinal malabsorption or any other condition in the opinion of the investigator that might affect the absorption of E7080
9. Major surgery within 3 weeks before enrollment
10. With co-existing effusion requiring drainage
20 Years
ALL
No
Sponsors
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Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Kashiwa, Chiba, Japan
Kobe, Hyōgo, Japan
Koto-ward, Tokyo, Japan
Countries
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References
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Takahashi S, Kiyota N, Yamazaki T, Chayahara N, Nakano K, Inagaki L, Toda K, Enokida T, Minami H, Imamura Y, Fukuda N, Sasaki T, Suzuki T, Ikezawa H, Dutcus CE, Tahara M. A Phase II study of the safety and efficacy of lenvatinib in patients with advanced thyroid cancer. Future Oncol. 2019 Mar;15(7):717-726. doi: 10.2217/fon-2018-0557. Epub 2019 Jan 14.
Tahara M, Kiyota N, Yamazaki T, Chayahara N, Nakano K, Inagaki L, Toda K, Enokida T, Minami H, Imamura Y, Sasaki T, Suzuki T, Fujino K, Dutcus CE, Takahashi S. Lenvatinib for Anaplastic Thyroid Cancer. Front Oncol. 2017 Mar 1;7:25. doi: 10.3389/fonc.2017.00025. eCollection 2017.
Other Identifiers
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E7080-J081-208
Identifier Type: -
Identifier Source: org_study_id
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