A Study of E7080 in Subjects With Advanced Thyroid Cancer

Eisai

Status and phase: Completed; Phase 2

Conditions: Thyroid Cancer

Treatments: Drug: E7080 capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT01728623

E7080-J081-208

Details and patient eligibility

About

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

Enrollment: 51 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

E7080

Experimental group

Treatment:

Drug: E7080 capsule