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

Overview

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.

Full Title of Study: “A PhaseⅠStudy of Apatinib Mesylate (YN968D1) 1,000mg in Patients With Unresectable Locally Advanced or Metastatic Gastric Cancer Failed to Standard Therapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2016

Interventions

  • Drug: Apatinib mesylate
    • 1,000mg Apatinib mesylate p.o. qd

Arms, Groups and Cohorts

  • Experimental: Apatinib mesylate

Clinical Trial Outcome Measures

Primary Measures

  • Dose-limiting toxicities (DLTs) of Apatinib mesylate in patients with unresectable locally advanced or metastatic gastric cancer
    • Time Frame: First 28 days of dosing
    • Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.03

Secondary Measures

  • Incidence of Adverse events (AEs), Serious AEs (SAEs), clinical laboratory abnormalities, and ECG abnormalities
    • Time Frame: From date of registration to time of first progressive disease(PD) or death, an average of 1 year
    • 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)
  • Duration of Response(Stable disease, partial response or Complete response)
    • Time Frame: From date of registration to time of first progressive disease(PD) or death, an average of 1 year
    • Tumor response and progression will be evaluated using RECIST v 1.1.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bukwang Pharmaceutical
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yoon-Koo Kang, PhD, Principal Investigator, Seoul Asan Medical Center

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