Trial Condition(s):

Thyroid Neoplasms

An Observational Study in differentiated thyroid cancer which is radioactive iodine (RAI) refractory to assess the use of Multikinase inhibitors (RIFTOS MKI)

Bayer Identifier:

17852

ClinicalTrials.gov Identifier:

NCT02303444

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The purpose of the study was to assess the use of Multikinase Inhibitors (MKIs) in the treatment of patients with a progressive differentiated thyroid carcinoma (DTC) refractory to radioactive iodine (RAI) who do not have any symptoms.

Inclusion Criteria
- Histologically/cytologically documented DTC (papillary, follicular, Hurthle cell, and poorly differentiated carcinoma)
 - DTC refractory to RAI
 - Radiological progression and preferably according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
 - No symptoms due to DTC
 - >/=1cm diameter of lesion confirmed by radiological exam
 - Life expectancy of at least 6 months
Exclusion Criteria
- Plan to be treated according to a clinical trial protocol for intervention including a locoregional therapy or systemic therapy
 - Previous treatment with MKIs for advanced disease
 - Hospice patients

Trial Summary

Enrollment Goal
667
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many locations, France

Status
Completed
 
Locations

Investigative Site

Many locations, Japan

Status
Completed
 
Locations

Investigative Site

Many locations, Spain

Status
Completed
 
Locations

Investigative Site

Many locations, Netherlands

Status
Completed
 
Locations

Investigative Site

Many locations, Argentina

Status
Completed
 
Locations

Investigative Site

Many locations, Turkey

Status
Completed
 
Locations

Investigative Site

Many locations, Greece

Status
Completed
 
Locations

Investigative Site

Many locations, Brazil

Status
Completed
 
Locations

Investigative Site

Many locations, Russia

Status
Completed
 
Locations

Investigative Site

Many locations, India

Status
Completed
 
Locations

Investigative Site

Many locations, Taiwan, China

Status
Completed
 
Locations

Investigative Site

Many locations, Algeria

Status
Completed
 
Locations

Investigative Site

Many locations, Egypt

Status
Completed
 
Locations

Investigative Site

Many locations, Saudi Arabia

Status
Completed
 
Locations

Investigative Site

Many locations, Lebanon

Status
Completed
 
Locations

Investigative Site

Many locations, Mexico

Status
Completed
 
Locations

Investigative Site

Philadelphia, United States

Status
Active, not recruiting
 
Locations

Investigative Site

Many locations, Philippines

Status
Completed
 
Locations

Investigative Site

Many Locations, Germany

Status
Completed
 
Locations

Investigative Site

Ann Arbor, United States

Status
Completed
 
Locations

Investigative Site

Washington, United States

Status
Completed
 
Locations

Investigative Site

Boston, United States

Status
Completed
 
Locations

Investigative Site

Bronx, United States

Status
Completed
 
Locations

Investigative Site

Atlanta, United States

Status
Completed
 
Locations

Investigative Site

Birmingham, United States

Status
Completed
 
Locations

Investigative Site

Torrance, United States

Status
Completed
 
Locations

Investigative Site

Chicago, United States

Status
Completed
 
Locations

Investigative Site

Durham, United States

Status
Completed
 
Locations

Investigative Site

Dallas, United States

Status
Completed
 
Locations

Investigative Site

New Orleans, United States

Status
Completed
 
Locations

Investigative Site

Aurora, United States

Status
Completed
 
Locations

Investigative Site

Los Angeles, United States

Status
Completed
 
Locations

Investigative Site

Plantation, United States

Status
Completed
 
Locations

Investigative Site

Honolulu, United States

Status
Completed
 
Locations

Investigative Site

Philadelphia, United States

Status
Completed
 

Trial Design