This is a non-randomized, phase II, open label study of Apatinib Mesylate in patients with Head and neck recurrent/metastatic adenoid cystic carcinoma (ACC). The primary purpose of this study is to evaluate the efficacy and safety of Apatinib Mesylate in patients with ACC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Apatinib Mesylate will be administered orally at 500 mg once daily for 5 consecutive days, and this was followed by a 2-day rest every week; each cycle consisted of 28 days
Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, China
Progression-free survival(PFS)
To determine 6 month PFS of Apatinib Mesylate when administered as monotherapy in patients with metastatic adenoid cystic carcinoma
Time frame: 6 months
Overall survival rate
from date of enrollment until date of first death from any cause, assessed up to 2 years
Time frame: 2 years
Response rate
CT scan will be evaluated every 2 cycles (per 8 weeks)till progression. Response rate will be evaluated by RECIST criteria
Time frame: 8 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
Time frame: through study completion, an average of 2 years
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