Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-02-20 @ 6:33 PM
Study NCT ID:
NCT02684266
Status:
COMPLETED
Last Update Posted:
2022-07-11
First Post:
2016-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of SHR6390 in Advanced Solid Tumor Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-07', 'studyFirstSubmitDate': '2016-02-12', 'studyFirstSubmitQcDate': '2016-02-16', 'lastUpdatePostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose', 'timeFrame': '5 weeks', 'description': 'The maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one out of three subjects experience a dose-limiting toxicity (DLT) within the first 3 week of the first cycle of multiple dosing'}], 'secondaryOutcomes': [{'measure': 'Number of patients experience adverse events', 'timeFrame': 'up to 12 months'}, {'measure': 'Evaluation of pharmacokinetic parameter of SHR6390: Cmax', 'timeFrame': '6 weeks'}, {'measure': 'Evaluation of pharmacokinetic parameter of SHR6390: Tmax', 'timeFrame': '6 weeks'}, {'measure': 'Evaluation of pharmacokinetic parameter of SHR6390: t1/2', 'timeFrame': '6 weeks'}, {'measure': 'Evaluation of pharmacokinetic parameter of SHR6390: AUC', 'timeFrame': '6 weeks'}, {'measure': 'Objective Response Rate', 'timeFrame': 'every 8 weeks, up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['neoplasm, Cycline-Dependent Kinase'], 'conditions': ['Neoplasm']}, 'referencesModule': {'references': [{'pmid': '33845905', 'type': 'DERIVED', 'citation': 'Zhang P, Xu B, Gui L, Wang W, Xiu M, Zhang X, Sun G, Zhu X, Zou J. A phase 1 study of dalpiciclib, a cyclin-dependent kinase 4/6 inhibitor in Chinese patients with advanced breast cancer. Biomark Res. 2021 Apr 12;9(1):24. doi: 10.1186/s40364-021-00271-2.'}]}, 'descriptionModule': {'briefSummary': 'SHR6390 is a small molecular, oral potent, selective CDK4/6 inhibitor. The purpose of this study is to investigate the safety/tolerability and the pharmacokinetic profile of SHR6390 in Chinese advanced solid tumor patients by using a "3+3" dose escalation.Preliminary efficacy will be also investigated in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pathologically confirmed solid tumor and failed from all standard treatment\n* Eastern Cooperative Oncology Group (ECOG) performance status: 0-1\n* Life expectancy ≥ 3 months\n* Adequate function of major organs, meaning the following criteria should be met within 14 days before randomization:\n\n * Hemoglobin \\> 110g/L\n * Neutrophils \\> 2.0×10\\^9/L\n * Platelets \\> 100×10\\^9/L\n * Total bilirubin \\< 1.5×the upper limit of normal (ULN)\n * ALT and AST ≤ 1.5×ULN (≤ 5×ULN, if existing liver metastases)\n * Creatinine ≤ 1 ULN\n * Left ventricular ejection fraction (LVEF) ≥ 50%\n * QTcF(Fridericia correction) male≤450 ms, female≤470 ms\n* Good compliance of patient by physician's judgement\n* Signed and dated informed consent\n\nExclusion Criteria:\n\n* Previously received therapy of anti-tumor agent targeting at CDK4/6\n* Less than 3 weeks from the last cell-toxicity chemotherapy, less than 6 weeks from last mitomycin or nitrosamine therapy\n* Less than 3 weeks from any other anti-tumor therapy (including targets therapy, immunotherapy or other approved therapy)\n* Having joined in other clinical trials within 4 weeks\n* Uncontrolled/untreated brain metastasis (well-controlled/well-treated brain metastasis by physician's judgement is allowed)\n* existing abnormal CTCAE≥grade 2 resulted from previous treatment(except grade 2 alopecia)\n* uncontrollable symptomatic pleural effusion or ascites or require clinical intervention\n* require continous treatment by steroids\n* Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.)\n* existing uncontrollable hypokalemia or hypomagnesemia\n* history of serious allergy events or known being allergy constitution\n* active HBV or HCV infection (HBV virus≥10e4 copies/ml, HCV virus≥10e3 copies/ml)\n* History of immunodeficiency, acquired or congenital immunodeficiency, history of organ transplantation\n* history of cardiac dysfunction, include(1)angina (2)clinical significant arrythmia or require drug intervention (3)myocardial infarction (4)heart failure (5) other cardiac dysfunction (judged by the physician); any cardiac or nephric abnormal ≥grade 2 found in screening\n* Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test childbearing female who refuse to accept any contraception practice\n* determined by the physician, any coexisting disease might lead to life threatening complications or avoid the patients from accomplishing the treatment(e.g serious hypertension, diabetes, thyroid dysfunction,etc.)\n* history of neuropathy or dysphrenia, including epilepsy and dementia"}, 'identificationModule': {'nctId': 'NCT02684266', 'briefTitle': 'A Study of SHR6390 in Advanced Solid Tumor Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Tolerability and Pharmacokinetics Study of SHR6390 in Advanced Solid Tumor Patients', 'orgStudyIdInfo': {'id': 'SHR6390-I-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR6390', 'description': 'Each subject will receive a single dose of SHR6390 and then repeat doses following a 3 week/1 week off regimen', 'interventionNames': ['Drug: SHR6390']}], 'interventions': [{'name': 'SHR6390', 'type': 'DRUG', 'description': 'SHR6390 either 25, 50mg, 75mg, 100mg, 125mg, 150mg, 175mg given orally, QD', 'armGroupLabels': ['SHR6390']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Cancer Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Binhe Xu, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Hosptial, Chinese Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}