The purpose of this phase II study of TKI258 (Dovitinib) in adenoid cystic carcinoma is to evaluate the efficacy of TKI258 (Dovitinib).
open, uncontrolled, multi-center, phase II study
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
TKI258 (Dovitinib): 500 mg daily po medication with 5 days on/2 days off schedule. TKI258 (Dovitinib) will be provided by Norvatis for the study purpose. One cycle consists of 4 weeks
Department of Internal Medicine, Seoul National University Hospital
Seoul, South Korea
progression free survival
To determine 4month progression-free survival of TKI258 (Dovitinib) when administered as monotherapy in patients with unresectable adenoid cystic carcinoma
Time frame: 4 month
overall survival
Time frame: 2 years
response rate
CT scan will be evaluated every 2 cycles (per 8 weeks)till progression. Reponse rate will be evaluated by RECIST criteria
Time frame: 8 weeks
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