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

NCT ID: NCT02711969

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-03-31

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apatinib mesylate

Group Type: EXPERIMENTAL

Apatinib mesylate

Intervention Type: DRUG

1,000mg Apatinib mesylate p.o. qd

Interventions

Apatinib mesylate

1,000mg Apatinib mesylate p.o. qd

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bukwang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoon-Koo Kang, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul Asan Medical Center

Locations

Asan medical center

Seoul, Songpa-gu, South Korea

Countries

South Korea

References

Kang YK, Ryu MH, Hong YS, Choi CM, Kim TW, Ryoo BY, Kim JE, Weis JR, Kingsford R, Park CH, Jang S, McGinn A, Werner TL, Sharma S. Phase 1/2a Study of Rivoceranib, a Selective VEGFR-2 Angiogenesis Inhibitor, in Patients with Advanced Solid Tumors. Cancer Res Treat. 2024 Jul;56(3):743-750. doi: 10.4143/crt.2023.980. Epub 2024 Jan 18.

Reference Type: DERIVED

PMID: 38271925 (View on PubMed)

Other Identifiers

BK-AM-GC102

Identifier Type: -

Identifier Source: org_study_id