A Study of Apatinib Mesylate (YN968D1) 1,000mg in Gastric Cancer Patient Failed to Standard Treatment

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bukwang Pharmaceutical
• Treatments: Apatinib

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