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A Phase 2 Study of E7080 in Subjects With Advanced Thyroid Cancer

Phase 2
20 Years
Open (Enrolling)
Thyroid Cancer

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Trial Information

A Phase 2 Study of E7080 in Subjects With Advanced Thyroid Cancer

Inclusion 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

Subjects 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 hr urine
collection for quantitative assessment of proteiuria

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Non-Serious Adverse Events and Serious Adverse Events

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Tatsuya Sasaki

Investigator Role:

Study Director

Investigator Affiliation:

Oncology Clinical Development Section, Japan / Asia Clinical Research, Product Creation Unit, Eisai Product Creation System


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

August 2012

Completion Date:

February 2015

Related Keywords:

  • Thyroid Cancer
  • Thyroid cancer
  • Thyroid Neoplasms
  • Thyroid Diseases