Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT03480256
Status:
UNKNOWN
Last Update Posted:
2019-03-14
First Post:
2018-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate SHR6390 Combined With Pyrotinib in Patients With HER2 Positive 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-12', 'studyFirstSubmitDate': '2018-03-08', 'studyFirstSubmitQcDate': '2018-03-27', 'lastUpdatePostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': '42 days'}], 'secondaryOutcomes': [{'measure': 'Maximum Plasma Concentration', 'timeFrame': '42 days'}, {'measure': 'Area Under the Curve', 'timeFrame': '42 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SHR6390', 'Pyrotinib', 'gastric cancer', 'Her-2 positive'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '32898333', 'type': 'DERIVED', 'citation': 'Chen Z, Xu Y, Gong J, Kou F, Zhang M, Tian T, Zhang X, Zhang C, Li J, Li Z, Lai Y, Zou J, Zhu X, Gao J, Shen L. Pyrotinib combined with CDK4/6 inhibitor in HER2-positive metastatic gastric cancer: A promising strategy from AVATAR mouse to patients. Clin Transl Med. 2020 Aug;10(4):e148. doi: 10.1002/ctm2.148.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the safety and tolerability of SHR6390 combined with pyrotinib in the patients with Her-2 positive advanced gastric cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients definitely diagnosed by pathology as Her2 positive stage III/IV gastric cancer\n* 18-75 years old, ECOG PS:0-1,Life expectancy of more than12 weeks;\n* Patients treated with systematic treatment to metastatic disease then experienced progressive disease\n* Patients with at least one evaluable or measurable disease per RECIST v1.1\n* Main organs function is normal;\n* Patients should be voluntary and sign the informed consent before taking part in the study;\n\nExclusion Criteria:\n\n* • Patients who have uncontrollable effusion with clinical symptoms such as severe pleural effusion and peritoneal effusion;\n\n * A variety of factors that affect oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.)\n * Patients who have steroid treatment for more than 30 days or need long-term steroid treatment;\n * Patients who had previously received chemotherapy，radiotherapy, hormonotherapy,surgery,targeted therapy(including Trastuzumab) within 2 weeks ;patients who had previously received nitrosourea or Mitomycin with 6 weeks;\n * Previous treatment-related adverse events did not recover to less than 2 levels except hair loss or other conditions that did not affect the enrollment according to investigators;\n * Patients who have participated in other anticancer drug clinical trials within 4 weeks except that trial is observational or at follow up stage;\n * Patients who have uncontrollable hypomagnesemia or hypokalemia;\n * Patients with untreated or symptomatic brain metastasis;\n * Patients with malignant tumors within 5 years, except for basal cell carcinoma,squamous skin cancer and cervical carcinoma in situ;\n * Patients who are being treated with any other anticancer strategies;\n * Patients with allergic constitution or being allergic to any element in the study drugs;\n * Patients with definite gastrointestinal bleeding tendency, including: active ulcer lesions with OB(++);melena or haematemesis history within 2 months; patients with OB(+) but without tumor resection need gastroscopy. If there is active bleeding, it's not suitable for this trial;\n * Patients with active infection, including tuberculosis;\n * Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history;\n * Patients who have had severe cardiac disease within six months, including acute coronary syndrome, arrhythmias that require medication or with clinical significance, or need continuous medication that may cause QT extension, acute myocardial infarction,heart failure,and any other condition that is not suitable for this experiment according to the investigators;\n * Patients who are pregnant or breast feeding;\n * Patients who don't agree on contraception; Patients with concomitant diseases which could seriously endanger themselves or those who won't complete the study according to investigators such as hypertension, severe diabetes and thyroid diseases;\n * Patients with bad addiction such as excessive drinking or smoking;\n * Patients with definite mental disorder, including epilepsy and dementia."}, 'identificationModule': {'nctId': 'NCT03480256', 'briefTitle': 'Study to Evaluate SHR6390 Combined With Pyrotinib in Patients With HER2 Positive Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Phase Id Trial to Evaluate SHR6390 Combined With Pyrotinib in Patients With HER2 Positive Advanced Stage Gastric Carcinoma', 'orgStudyIdInfo': {'id': 'SHR6390-Id'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR6390 combined with pyrotinib', 'description': 'Group A:pyrotinib 400mg qd combined with SHR 6390 100mg qd Group B: pyrotinib 400mg qd combined with SHR 6390 125mg qd Group C: pyrotinib 400mg qd combined with SHR 6390 150mg qd Group D: pyrotinib 400mg qd combined with SHR 6390 175mg qd Group E: pyrotinib 320mg qd combined with SHR 6390 100mg qd', 'interventionNames': ['Drug: SHR6390']}], 'interventions': [{'name': 'SHR6390', 'type': 'DRUG', 'description': 'SHR6390 is a novel small molecule inhibitor specifically targeting the CDK4/6 pathway.Pyrotinib is an irreversible pan-ErbB inhibitor which shows promising antitumour activity in patients with HER2-positive metastatic gastric cancer', 'armGroupLabels': ['SHR6390 combined with pyrotinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shen Lin, Professor', 'role': 'CONTACT', 'email': 'Linshenpku@163.com', 'phone': '010-88196561'}, {'name': 'Shen Lin, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jifang Gong, MD', 'role': 'CONTACT', 'email': 'gongjifang@gmail.com', 'phone': '861088196561'}, {'name': 'Lin Shen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of GI Oncology, Peking University Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jifang Gong', 'role': 'CONTACT', 'email': 'goodjf@163.com', 'phone': '13683208528'}], 'overallOfficials': [{'name': 'Lin Shen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Gastrointestinal Oncology,Peking University Cancer Hospital', 'investigatorFullName': 'Shen Lin', 'investigatorAffiliation': 'Peking University'}}}}