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A Study of E7080 in Subjects With Advanced Thyroid Cancer

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ClinicalTrials.gov Identifier: NCT01728623
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Brief 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.

Condition or disease Intervention/treatment Phase
Thyroid Cancer Drug: E7080 capsule Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of E7080 in Subjects With Advanced Thyroid Cancer
Study Start Date : September 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: E7080 Drug: E7080 capsule
E7080 is administered as continuous once daily dosing in an uncontrolled manner




Primary Outcome Measures :
  1. Number of Participants with Non-Serious Adverse Events and Serious Adverse Events [ Time Frame: 2 years ]
  2. Change from baseline in hematology, blood biochemistry, urinalysis, vital signs, ECG, physical test data [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: From Study Start until progression of disease or date of death from any cause, whichever comes first, assessed up to 40 months ]
  2. Overall survival [ Time Frame: From Study Start until date of death from any cause, assessed up to 40 months ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728623


Locations
Japan
Kashiwa, Chiba, Japan
Kobe, Hyogo, Japan
Koto-ward, Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Tatsuya Sasaki Oncology Clinical Development Section, Japan / Asia Clinical Research, Product Creation Unit, Eisai Product Creation System

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT01728623     History of Changes
Other Study ID Numbers: E7080-J081-208
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Thyroid cancer

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Lenvatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action