An open study to evaluate the safety of apatinib mesylate (YN968D1) 1,000mg monotherapy in patients with unresectable locally advanced or metastatic Gastric cancer failed to standard therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
1,000mg Apatinib mesylate p.o. qd
Asan medical center
Seoul, Songpa-gu, South Korea
Dose-limiting toxicities (DLTs) of Apatinib mesylate in patients with unresectable locally advanced or metastatic gastric cancer
Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.03
Time frame: First 28 days of dosing
Incidence of Adverse events (AEs), Serious AEs (SAEs), clinical laboratory abnormalities, and ECG abnormalities
Incidence and severity of treatment-related adverse events reported and their relationship to Apatinib mesylate will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.3)
Time frame: From date of registration to time of first progressive disease(PD) or death, an average of 1 year
Duration of Response(Stable disease, partial response or Complete response)
Tumor response and progression will be evaluated using RECIST v 1.1.
Time frame: From date of registration to time of first progressive disease(PD) or death, an average of 1 year
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