An Observational Study in Differentiated Thyroid Cancer Which is Radioactive Iodine (RAI) Refractory to Assess the Use of Multikinase Inhibitors
NCT ID: NCT02303444
Last Updated: 2023-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
667 participants
OBSERVATIONAL
2015-04-08
2020-07-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MKI patients
Asymptomatic patients with RAI-refractory progressive DTC for whom there is a decision to initiate MKIs at study entry. For patients on sorafenib, treatment start and stop dates will be collected along with any adverse events observed.
Sorafenib (Nexavar, BAY43-9006)
Patients can get sorafenib at any time during study.
Other Multikinase inhibitors
Patients can get MKIs at any time during study.
non-MKI patients
Asymptomatic patients with RAI-refractory progressive DTC for whom there is a decision to not initiate MKIs at study entry. For patients on sorafenib, treatment start and stop dates will be collected along with any adverse events observed.
Sorafenib (Nexavar, BAY43-9006)
Patients can get sorafenib at any time during study.
Other Multikinase inhibitors
Patients can get MKIs at any time during study.
Interventions
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Sorafenib (Nexavar, BAY43-9006)
Patients can get sorafenib at any time during study.
Other Multikinase inhibitors
Patients can get MKIs at any time during study.
Eligibility Criteria
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Inclusion Criteria
* 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
* Previous treatment with MKIs for advanced disease
* Hospice patients
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, Alabama, United States
Los Angeles, California, United States
Torrance, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Plantation, Florida, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
The Bronx, New York, United States
Durham, North Carolina, United States
Philadelphia, Pennsylvania, United States
Dallas, Texas, United States
Multiple Locations, , Algeria
Multiple Locations, , Argentina
Multiple Locations, , Brazil
Multiple Locations, , Egypt
Multiple Locations, , France
Multiple Locations, , Germany
Multiple Locations, , Greece
Multiple Locations, , India
Multiple Locations, , Japan
Multiple Locations, , Lebanon
Multiple Locations, , Mexico
Multiple Locations, , Netherlands
Multiple Locations, , Philippines
Multiple Locations, , Russia
Multiple Locations, , Saudi Arabia
Multiple Locations, , Spain
Multiple Locations, , Taiwan
Multiple Locations, , Turkey (Türkiye)
Countries
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References
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Gianoukakis AG, Choe JH, Bowles DW, Brose MS, Wirth LJ, Owonikoko T, Babajanyan S, Worden FP. Real-world practice patterns and outcomes for RAI-refractory differentiated thyroid cancer. Eur Thyroid J. 2024 Jan 24;13(1):e230039. doi: 10.1530/ETJ-23-0039. Print 2024 Feb 1.
Brose MS, Smit JWA, Lin CC, Tori M, Bowles DW, Worden F, Shen DH, Huang SM, Tsai HJ, Alevizaki M, Peeters RP, Takahashi S, Rumyantsev P, Guan R, Babajanyan S, Ozgurdal K, Sugitani I, Pitoia F, Lamartina L. Multikinase Inhibitors for the Treatment of Asymptomatic Radioactive Iodine-Refractory Differentiated Thyroid Cancer: Global Noninterventional Study (RIFTOS MKI). Thyroid. 2022 Sep;32(9):1059-1068. doi: 10.1089/thy.2022.0061.
Porcelli T, Luongo C, Sessa F, Klain M, Masone S, Troncone G, Bellevicine C, Schlumberger M, Salvatore D. Long-term management of lenvatinib-treated thyroid cancer patients: a real-life experience at a single institution. Endocrine. 2021 Aug;73(2):358-366. doi: 10.1007/s12020-021-02634-z. Epub 2021 Feb 3.
Brose MS, Smit J, Lin CC, Pitoia F, Fellous M, DeSanctis Y, Schlumberger M, Tori M, Sugitani I. Timing of multikinase inhibitor initiation in differentiated thyroid cancer. Endocr Relat Cancer. 2017 May;24(5):237-242. doi: 10.1530/ERC-17-0016. Epub 2017 Mar 7.
Related Links
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Click here to find results for studies related to Bayer Healthcare products.
Other Identifiers
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NX1401
Identifier Type: OTHER
Identifier Source: secondary_id
17852
Identifier Type: -
Identifier Source: org_study_id
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