Status:
COMPLETED
An Observational Study in Differentiated Thyroid Cancer Which is Radioactive Iodine (RAI) Refractory to Assess the Use of Multikinase Inhibitors
Lead Sponsor:
Bayer
Conditions:
Thyroid Neoplasms
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
The primary objective of this study was to compare time to symptomatic progression (TTSP) from study entry in asymptomatic patients with RAI-refractory progressive DTC for whom there is a decision to ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 8 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 24 2020
Estimated Enrollment :
667 Patients enrolled
Trial Details
Trial ID
NCT02303444
Start Date
April 8 2015
End Date
July 24 2020
Last Update
June 8 2023
Active Locations (34)
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1
Birmingham, Alabama, United States
2
Los Angeles, California, United States
3
Torrance, California, United States
4
Aurora, Colorado, United States