Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-02-23 @ 4:53 PM
Study NCT ID:
NCT02764268
Status:
COMPLETED
Last Update Posted:
2022-03-11
First Post:
2016-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Apatinib Dose Titration in Advanced or Metastatic Gastric Cancer
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-24', 'studyFirstSubmitDate': '2016-04-27', 'studyFirstSubmitQcDate': '2016-05-04', 'lastUpdatePostDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dose Interruptions', 'timeFrame': '15 months'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE(Common Terminology Criteria for Adverse Events) v4.0', 'timeFrame': '15 months'}, {'measure': 'Objective Response Rate(ORR)', 'timeFrame': '15 months', 'description': 'Number of Participants Who Reached Complete Response and Partial Response Assessed by Recist(Response Evaluation Criteria in Solid Tumors)1.1 at the End of the Second Treatment Cycle.'}, {'measure': 'Disease Control Rate(DCR)', 'timeFrame': '15 months', 'description': 'Number of Participants Who Reached Complete Response and Partial Response and Stable Disease Assessed by Recist(Response Evaluation Criteria in Solid Tumors)1.1 at the End of the Second Treatment Cycle.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastric Cancer', 'Pharmacokinetics', 'Dose titration'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '36330490', 'type': 'DERIVED', 'citation': 'Wang Y, Wang C, Zhang Y, Hao J, Yang N, Wang J, Peng M, Liu T, Zhang G, Zhan X, Zeng S, Zhang Y, Gao Y, Yao Y. Multiple-dose up-titration study to evaluate the pharmacokinetics, safety and antitumor activity of apatinib in advanced gastric adenocarcinoma. Front Oncol. 2022 Oct 18;12:876899. doi: 10.3389/fonc.2022.876899. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Apatinib dose titration in Advanced or Metastatic Gastric Cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥ 18 and ≤ 70 years of age\n2. Histological confirmed advanced or metastatic adenocarcinoma of the stomach\n3. Have failed for at least 2 lines of chemotherapy\n4. Life expectancy of at least 12 weeks\n5. Eastern Cooperative Oncology Group Performance Status of 0 or 1\n6. At least one measurable lesion beyond stomach (larger than 10 mm in diameter by spiral CT scan)\n7. Duration from the last therapy is more than 6 weeks for nitroso or mitomycin\n8. More than 4 weeks for operation or radiotherapy or cytotoxic agents\n9. Adequate hepatic, renal, heart, and hematologic functions\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix\n3. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg)\n4. Any factors that influence the usage of oral administration\n5. Evidence of central nerves system metastasis\n6. Intercurrence with one of the following: coronary artery disease, arrhythmia ,heart failure\n7. proteinuria ≥ (+)\n8. International Normalized Ratio \\> 1.5 and activated partial thromboplastin time \\> 1.5 × Upper limit of normal（ULN）\n9. Certain possibility of gastric or intestine hemorrhage\n10. Less than 4 weeks from the last clinical trial\n11. Prior VEGFR inhibitor treatment\n12. Disability of serious uncontrolled intercurrence infection Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, Pneumoconiosis, radiation pneumonitis, drug-related pneumonia, Pulmonary function damaged seriously etc'}, 'identificationModule': {'nctId': 'NCT02764268', 'briefTitle': 'Apatinib Dose Titration in Advanced or Metastatic Gastric Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'Apatinib Dose Titration: Analyses of Exposure, Safety and Efficacy in Advanced or Metastatic Gastric Cancer', 'orgStudyIdInfo': {'id': 'HR-APTN-DT-AGC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apatinib', 'interventionNames': ['Drug: Apatinib']}], 'interventions': [{'name': 'Apatinib', 'type': 'DRUG', 'armGroupLabels': ['Apatinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200233', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai 6th People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}