a study of apatinib mesylate (yn968d1) 1,000mg in gastric cancer patient failed to standard treatment

Conditions: Gastric Cancer

Summary: 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.


Eligibility criteria:
inclusion criteria: * 19 years of age or older * subjects with histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction * failure or noncompliance of existing standard treatment without alternative treatment * measurable disease measured by proper image examination defined by recist 1.1 * life expectancy ≥ 3 months * subject must be suitable for oral administration of study medication * subject who can submit a written consent form before participating in the test * adequate bone marrow, renal, and liver function * electrocorticography(ecog) performance status ≤ 2 * ability and willingness to comply with the study protocol for the duration of the study exclusion criteria: * pregnant or lactating women * therapy with clinically significant systemic anticoagulant or antithrombotic agents within 7 days prior to first scheduled dose of yn968d1 * hemoptysis within 3 months prior to first scheduled dose of yn968d1 * cytotoxic chemotherapy, immunotherapy, radiotherapy or other targeted therapies within 4 weeks (6 weeks in cases of mitomycin c, nitrosourea, lomustine) prior to first scheduled dose of yn968d1 * surgery or biopsy within 28 days prior to first scheduled dose of yn968d1 * minor surgery within 7 days prior to first scheduled dose of yn968d1 * patients who have experience using yn968d1 before * concomitant treatment with strong inhibitors or inducers of cyp3a4, cyp2c9 and cyp2c19 * known history of human immunodeficiency virus infection (hiv) * medical history of other cancers (including blood cancer) in the 5 years * radiology therapy to target lesion within 28 days, or diagnosis of other cancer within 14 days prior to first scheduled dose of yn968d1 * history of bleeding diathesis or bleeding within 14 days prior to enrollment * medical history of clinically significant thrombosis (bleeding or clotting disorder) within the past 3-months * history of non-malignant gi bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months * history of idiopathic or hereditary angioedema, sickle cell or any hemolytic anemia * history of uncontrolled hypertension that in the opinion of the investigator * complete left bundle branch block (lbbb) or bifascicular (rbbb and left anterior or posterior hemi-block) * clinically significant s-t segment or t wave abnormality * abnormal atrial fibrillation * history of ecog or left ventricular ejection fraction (lvef) abnormality during last 3 months in the opinion of the investigator * myocardial infarction or unstable angina pectoris within 6 months prior to starting study medication * congestive heart failure (new york heart association class iii-iv) * history of other significant cardiovascular disease or vascular disease within the last 6 months * history of clinically significant glomerulonephritis, biopsy proven tubulointerstitial nephritis, crystal nephropathy, or other renal insufficiencies treatment with an investigational agent within the longest time frame of either 5 half-lives or 30 days of initiating study drug * half-life of other investigator drug is not passed over fivefold or 30 days prior to clinical trial * known recreational substance use or psychiatric illness that, in the opinion of the investigator, may affect compliance with scheduled visits * known hypersensitivity to yn968d1 or components of the formulation