Phase I Study of Axitinib and Temsirolimus in Solid Tumors
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST(Response Evaluation Criteria in Solid Tumors)criteria for evaluation.
Complete Response:Disappearance of all target lesions.Any pathological lymph nodes must have reduction in short axis to <10 mm. Partial Response:At least a 30% decrease in the sum of the diameters of target lesions Progressive Disease:At least a 20% increase in the sum of the diameters of target lesions.Note: the appearance of one or more new lesions is also considered progressions). Stable Disease:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Approximately re-evaluated every 8 weeks
John Kauh, MD
Emory University Winship Cancer Institute
United States: Food and Drug Administration
|Emory University Winship Cancer Institute||Atlanta, Georgia 30322|