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

Bukwang Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Gastric Cancer

Treatments

Drug: Apatinib mesylate

Study type

Interventional

Funder types

Industry

Identifiers

NCT02711969

BK-AM-GC102

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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