Patients were randomized 2:1 to cabozantinib or matching placebo. Randomization was stratified by prior lenvatinib (yes or no) and age (≤65 or >65 years). Patients received a 60 mg tablet of cabozantinib or a matched placebo, which was self-administered orally once per day. All patients received best supportive care, and adverse events (AEs) were managed with dose modification (dose interruptions or reductions) and supportive care. Dose interruptions were allowed for up to 8 weeks or longer with sponsor approval. Dose reductions were from 60 to 40 mg daily and then to 20 mg daily. Patients were treated until disease progression by RECIST version 1.1 or unacceptable toxicity. Treatment beyond disease progression was allowed if patients experienced clinical benefit in the opinion of the investigator. Importantly, patients in the placebo arm who experienced disease progression per blinded independent radiology committee (BIRC) were permitted to crossover and receive open-label cabozantinib.
Capdevila J., Krajewska J., Hernando J., Robinson B., Sherman S.I., Jarzab B., Lin C.C., Vaisman F., Hoff A.O., Hitre E., Bowles D.W., Williamson D., Levytskyy R., Oliver J., Keam B, & Brose M.S. (2024). Increased Progression-Free Survival with Cabozantinib Versus Placebo in Patients with Radioiodine-Refractory Differentiated Thyroid Cancer Irrespective of Prior Vascular Endothelial Growth Factor Receptor-Targeted Therapy and Tumor Histology: A Subgroup Analysis of the COSMIC-311 Study. Thyroid, 34(3), 347-359.
Other organizations :
The Maria Sklodowska-Curie National Research Institute of Oncology, University of Sydney, The University of Texas MD Anderson Cancer Center, National Taiwan University Hospital, Instituto Nacional do Câncer, Instituto do Câncer do Estado de São Paulo, Universidade de São Paulo, National Institute of Criminology, University of Colorado Anschutz Medical Campus, Exelixis (United States), Seoul National University Hospital, University of Pennsylvania
Dose modification (dose interruptions or reductions) and supportive care
positive control
Open-label cabozantinib for patients in the placebo arm who experienced disease progression
negative control
Matching placebo
Annotations
Based on most similar protocols
Etiam vel ipsum. Morbi facilisis vestibulum nisl. Praesent cursus laoreet felis. Integer adipiscing pretium orci. Nulla facilisi. Quisque posuere bibendum purus. Nulla quam mauris, cursus eget, convallis ac, molestie non, enim. Aliquam congue. Quisque sagittis nonummy sapien. Proin molestie sem vitae urna. Maecenas lorem.
As authors may omit details in methods from publication, our AI will look for missing critical information across the 5 most similar protocols.
About PubCompare
Our mission is to provide scientists with the largest repository of trustworthy protocols and intelligent analytical tools, thereby offering them extensive information to design robust protocols aimed at minimizing the risk of failures.
We believe that the most crucial aspect is to grant scientists access to a wide range of reliable sources and new useful tools that surpass human capabilities.
However, we trust in allowing scientists to determine how to construct their own protocols based on this information, as they are the experts in their field.
Ready to
get started?
Sign up for free.
Registration takes 20 seconds.
Available from any computer
No download required
