A Study of E7080 in Subjects With Advanced Thyroid Cancer

NCT ID: NCT01728623

Last Updated: 2020-08-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-03

Study Completion Date

2015-10-01

Brief Summary

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This study is to evaluate the safety, efficacy, and pharmacokinetics of E7080 when orally administered once daily (QD) in subjects with advanced thyroid cancer.

Detailed Description

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Conditions

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Thyroid Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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E7080

Group Type EXPERIMENTAL

E7080 capsule

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Histologically or clinically diagnosed with thyroid cancer
2. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-2
3. Adequate laboratory values/organ function tests

Exclusion Criteria

Participants with following complication or disease history

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kashiwa, Chiba, Japan

Site Status

Kobe, Hyōgo, Japan

Site Status

Koto-ward, Tokyo, Japan

Site Status

Countries

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Japan

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.

Reference Type DERIVED
PMID: 30638399 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28299283 (View on PubMed)

Other Identifiers

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E7080-J081-208

Identifier Type: -

Identifier Source: org_study_id

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