Clinical trial NCT02711969: A Study of Apatinib Mesylate (YN968D1) 1,000mg in Gastric Cancer Patient Failed to Standard Treatment
Official title: A PhaseⅠStudy of Apatinib Mesylate (YN968D1) 1,000mg in Patients With Unresectable Locally Advanced or Metastatic Gastric Cancer Failed to Standard Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastric Cancer
Lead sponsor: Bukwang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2016-03-17
Enrollment: 6
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Dose-limiting toxicities (DLTs) of Apatinib mesylate in patients with unresectable locally advanced or metastatic gastric cancer
timeFrame: First 28 days of dosing
Secondary outcomes:
measure: Incidence of Adverse events (AEs), Serious AEs (SAEs), clinical laboratory abnormalities, and ECG abnormalities
timeFrame: From date of registration to time of first progressive disease(PD) or death, an average of 1 year
measure: Duration of Response(Stable disease, partial response or Complete response)
timeFrame: From date of registration to time of first progressive disease(PD) or death, an average of 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
state: Songpa-gu
Study officials:
affiliation: Seoul Asan Medical Center
name: Yoon-Koo Kang, PhD
role: PRINCIPAL_INVESTIGATOR
References: