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Predictors of exposure, therapeutic and adverse effects of lenvatinib used in the treatment of advanced thyroid cancer.
Proposal
5565
Title of Proposed Research
Predictors of exposure, therapeutic and adverse effects of lenvatinib used in the treatment of advanced thyroid cancer.
Lead Researcher
Ashley Hopkins
Affiliation
Flinders University
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
14 Feb 2019
Lay Summary
Advanced cancers are difficult to treat. Lenvatinib is an important treatment for advanced thyroid cancer. However, response and toxicity to lenvatinib is highly unpredictable, with up to 40% of the patients who initiate not responding, and 40% experiencing some toxicity. Using the diverse range of data collected from clinical trials, it is possible to develop clinical tools that enable improved prediction of therapeutic and adverse outcomes of patients using lenvatinib in the treatment of advanced thyroid cancer. Being able to identify the expected response and adverse effect profile may enable patients and clinicians to make better decisions regarding whether to commence, continue, discontinue or change dosing of lenvatinib.
Study Data Provided
[{ "PostingID": 3634, "Title": "EISAI-E7080-G000-201", "Description": "Phase II, Multicenter, Open-label, Single Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology" },{ "PostingID": 3636, "Title": "EISAI-E7080-G000-303", "Description": "A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer" }]
Statistical Analysis Plan
Publication Citation
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