Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-03-21 @ 11:59 AM
Study NCT ID:
NCT03092128
Status:
UNKNOWN
Last Update Posted:
2018-09-13
First Post:
2017-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Pharmacokinetics and Pharmacogenomics Research of Imatinib in Gastrointestinal Stromal Tumor Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046152', 'term': 'Gastrointestinal Stromal Tumors'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '1. FFPE samples of tissue needle biopsy were used for KIT and PDGFRA mutation detection.\n2. EDTA-whole blood was centrifuged at 4000rpm\\*10min,plasma was separated within four hours for somatic mutation detection.The remaining samples were used for germline mutation detection. All the blood samples were frozen in -80℃ until analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-11', 'studyFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2017-03-21', 'lastUpdatePostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': 'The time from the date of randomisation (baseline) to the date of objective tumour progression，and expected average of 36 months.', 'description': 'Excluding clinical deterioration without evidence of objective progression according to the Response Evaluation Criteria In Solid Tumors (RECIST), or death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Number of patients with objective response and adverse events', 'timeFrame': 'one month, three month, 12 month', 'description': 'Objective responses (complete response plus partial response) and disease control (objective response plus stable disease≥6 weeks) were established according to RECIST.And adverse events was established according to CTCAE.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastrointestinal stromal tumor (GIST)', 'Imatinib', 'Pharmacogenetics', 'Pharmacokinetics', 'Precision medicine', 'Somatic and germ-line mutations'], 'conditions': ['Gastrointestinal Stromal Tumors', 'Germline Mutation', 'Somatic Mutation', 'Plasma Concentration']}, 'referencesModule': {'references': [{'pmid': '23746188', 'type': 'BACKGROUND', 'citation': 'Angelini S, Ravegnini G, Fletcher JA, Maffei F, Hrelia P. Clinical relevance of pharmacogenetics in gastrointestinal stromal tumor treatment in the era of personalized therapy. Pharmacogenomics. 2013 Jun;14(8):941-56. doi: 10.2217/pgs.13.63.'}, {'pmid': '19451435', 'type': 'BACKGROUND', 'citation': 'Demetri GD, Wang Y, Wehrle E, Racine A, Nikolova Z, Blanke CD, Joensuu H, von Mehren M. Imatinib plasma levels are correlated with clinical benefit in patients with unresectable/metastatic gastrointestinal stromal tumors. J Clin Oncol. 2009 Jul 1;27(19):3141-7. doi: 10.1200/JCO.2008.20.4818. Epub 2009 May 18.'}, {'pmid': '26851399', 'type': 'BACKGROUND', 'citation': 'Bouchet S, Poulette S, Titier K, Moore N, Lassalle R, Abouelfath A, Italiano A, Chevreau C, Bompas E, Collard O, Duffaud F, Rios M, Cupissol D, Adenis A, Ray-Coquard I, Bouche O, Le Cesne A, Bui B, Blay JY, Molimard M. Relationship between imatinib trough concentration and outcomes in the treatment of advanced gastrointestinal stromal tumours in a real-life setting. Eur J Cancer. 2016 Apr;57:31-8. doi: 10.1016/j.ejca.2015.12.029. Epub 2016 Feb 4.'}, {'pmid': '23623056', 'type': 'BACKGROUND', 'citation': 'Joensuu H, Hohenberger P, Corless CL. Gastrointestinal stromal tumour. Lancet. 2013 Sep 14;382(9896):973-83. doi: 10.1016/S0140-6736(13)60106-3. Epub 2013 Apr 24.'}], 'seeAlsoLinks': [{'url': 'http://english.sysucc.org.cn/', 'label': 'Collaborative Innovation Center for Cancer Medicine Sun Yat-sen University Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'For patients of GIST (Gastrointestinal Stromal Tumor), Imatinib has been widely used in GIST with KIT or PDGFRA sensitive mutations. From clinical points of view, individual differences often occur between different patients, leading diverse effect in ADR and drug effect. Meanwhile, the drug effect and adverse drug reaction was significantly influenced by the pharmacokinetic factors and pharmacodynamic and other factors. In this research, we try to establish a more sensitive method to detect sensitive mutations in plasma and discover the correlation between somatic and germline mutations, plasma trough concentration and drug effect, the association between ADME-associated SNP, Target/Receptor/Pathway-associated SNP, trough concentration and TKI adverse effect. Furthermore, in vivo and in vitro research is also crucial for rational explanation for these clinical phenomenon.', 'detailedDescription': 'The plasma concentration of Imatinib were established. The ADME-associated SNPs included are CYP3A4, CYP3A4, CYP1A1, CYP2C9, CYP2C19, ABCB1, ABCG2, ABCC4, SLC22A1, SLCO1B3 and so on. The Target/Receptor/Pathway-associated SNP s included KIT, PDGFRA, PDGFRB, FLT1, FLT3, MAPK1, SHC1, CCL5, CXCL14 and so on. The somatic mutations included are KIT, PDGFRA, BRAF and so on.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'GIST (Gastrointestinal stromal tumor) patients; administrated with Imatinib and Sunitinib.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The main patient entry criteria included: age≥ 18 years; histologically and cytologically proved GIST; Eastern cooperative oncology group performance status (ECOGPS)≤2; adequate hematological,renal,and hepatic functions.\n\nExclusion Criteria:\n\n* uncontrolled systemic disease,and other chemotherapy at the time of inclusion. The protocol was approved by the Ethical Committee of Cancer Center of Sun Yat-Sen University (CCSU), and written informed consent was obtained form each patient.'}, 'identificationModule': {'nctId': 'NCT03092128', 'briefTitle': 'A Retrospective Pharmacokinetics and Pharmacogenomics Research of Imatinib in Gastrointestinal Stromal Tumor Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Retrospective Study Based on Pharmacokinetics, Somatic Mutations and Genetic Polymorphisms Related to Individual Variations of Drug Effect and Adverse Drug Reaction of Imatinib in Gastrointestinal Stromal Tumor Treatment.', 'orgStudyIdInfo': {'id': 'SYSUCC20141021007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'sensitive group; non-sensitive group', 'description': 'sensitive patients were defined as patients reached CR or PR after first month administration,SD after first three months administration. non-sensitive patients were defined as patients reached PD after first month administration and first three months administration.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Zhuang, Ph. D', 'role': 'CONTACT', 'email': 'zhuangw@mail2.sysu.edu.cn', 'phone': '86-13427526343'}, {'name': 'Min Huang, Professor', 'role': 'CONTACT', 'email': 'huangmin@mail.sysu.edu.cn', 'phone': '+86 020 87331409', 'phoneExt': '101'}], 'facility': 'Institute of Clinical Pharmacology, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Wei Zhuang, Ph.D', 'role': 'CONTACT', 'email': 'zhuangw@mail2.sysu.edu.cn', 'phone': '86-13427526343'}, {'name': 'Min Huang, Professor', 'role': 'CONTACT', 'email': 'Huangmin@mail.sysu.edu.cn', 'phone': '86-020-39943027'}], 'overallOfficials': [{'name': 'Min Huang, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Clinical Pharmacology, SunYat-senU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xueding Wang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sun Yat-sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Institute of Clinical Pharmacology', 'investigatorFullName': 'Xueding Wang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}