Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-02-22 @ 8:24 AM
Study NCT ID:
NCT02711969
Status:
COMPLETED
Last Update Posted:
2022-07-22
First Post:
2016-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Apatinib Mesylate (YN968D1) 1,000mg in Gastric Cancer Patient Failed to Standard Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C553458', 'term': 'apatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-20', 'studyFirstSubmitDate': '2016-02-26', 'studyFirstSubmitQcDate': '2016-03-16', 'lastUpdatePostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicities (DLTs) of Apatinib mesylate in patients with unresectable locally advanced or metastatic gastric cancer', 'timeFrame': 'First 28 days of dosing', 'description': 'Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.03'}], 'secondaryOutcomes': [{'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', 'description': '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)'}, {'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', 'description': 'Tumor response and progression will be evaluated using RECIST v 1.1.'}]}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '38271925', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19 years of age or older\n* Subjects with histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction\n* Failure or noncompliance of existing standard treatment without alternative treatment\n* Measurable disease measured by proper image examination defined by RECIST 1.1\n* Life expectancy ≥ 3 months\n* Subject must be suitable for oral administration of study medication\n* Subject who can submit a written consent form before participating in the test\n* Adequate bone marrow, renal, and liver function\n* Electrocorticography(ECOG) performance status ≤ 2\n* Ability and willingness to comply with the study protocol for the duration of the study\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Therapy with clinically significant systemic anticoagulant or antithrombotic agents within 7 days prior to first scheduled dose of YN968D1\n* Hemoptysis within 3 months prior to first scheduled dose of YN968D1\n* 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\n* Surgery or biopsy within 28 days prior to first scheduled dose of YN968D1\n* Minor surgery within 7 days prior to first scheduled dose of YN968D1\n* Patients who have experience using YN968D1 before\n* Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19\n* Known history of human immunodeficiency virus infection (HIV)\n* Medical history of other cancers (including blood cancer) in the 5 years\n* Radiology therapy to target lesion within 28 days, or diagnosis of other cancer within 14 days prior to first scheduled dose of YN968D1\n* History of bleeding diathesis or bleeding within 14 days prior to enrollment\n* Medical history of clinically significant thrombosis (bleeding or clotting disorder) within the past 3-months\n* History of non-malignant GI bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months\n* History of idiopathic or hereditary angioedema, sickle cell or any hemolytic anemia\n* History of uncontrolled hypertension that in the opinion of the investigator\n* Complete Left bundle branch block (LBBB) or bifascicular (RBBB and left anterior or posterior hemi-block)\n* Clinically significant S-T segment or T wave abnormality\n* Abnormal atrial fibrillation\n* History of ECOG or left ventricular ejection fraction (LVEF) abnormality during last 3 months in the opinion of the investigator\n* Myocardial infarction or unstable angina pectoris within 6 months prior to starting study medication\n* Congestive heart failure (New York Heart Association class III-IV)\n* History of other significant cardiovascular disease or vascular disease within the last 6 months\n* 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\n* Half-life of other investigator drug is not passed over fivefold or 30 days prior to clinical trial\n* Known recreational substance use or psychiatric illness that, in the opinion of the Investigator, may affect compliance with scheduled visits\n* Known hypersensitivity to YN968D1 or components of the formulation'}, 'identificationModule': {'nctId': 'NCT02711969', 'briefTitle': 'A Study of Apatinib Mesylate (YN968D1) 1,000mg in Gastric Cancer Patient Failed to Standard Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bukwang Pharmaceutical'}, 'officialTitle': 'A PhaseⅠStudy of Apatinib Mesylate (YN968D1) 1,000mg in Patients With Unresectable Locally Advanced or Metastatic Gastric Cancer Failed to Standard Therapy', 'orgStudyIdInfo': {'id': 'BK-AM-GC102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apatinib mesylate', 'interventionNames': ['Drug: Apatinib mesylate']}], 'interventions': [{'name': 'Apatinib mesylate', 'type': 'DRUG', 'description': '1,000mg Apatinib mesylate p.o. qd', 'armGroupLabels': ['Apatinib mesylate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'Songpa-gu', 'country': 'South Korea', 'facility': 'Asan medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yoon-Koo Kang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bukwang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}