A Study of E7080 in Subjects With Advanced Thyroid Cancer

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Co., Ltd.
• Treatments: Lenvatinib

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