Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-01 @ 11:17 AM
Study NCT ID:
NCT01579357
Status:
COMPLETED
Last Update Posted:
2015-03-09
First Post:
2012-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Metabolic Activation of Capecitabine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-11-01', 'releaseDate': '2017-06-19'}, {'releaseDate': '2017-12-06', 'unreleaseDateUnknown': True}, {'releaseDate': '2019-01-08', 'unreleaseDate': '2019-01-21'}, {'resetDate': '2019-04-19', 'releaseDate': '2019-01-21'}], 'estimatedResultsFirstSubmitDate': '2017-06-19'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-06', 'studyFirstSubmitDate': '2012-03-29', 'studyFirstSubmitQcDate': '2012-04-17', 'lastUpdatePostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Influence of Cetuximab on metabolic activation of Capecitabine', 'timeFrame': '9 weeks', 'description': 'Curve fitting of drug and metabolite concentrations will be performed. For pharmacokinetic modelling of CCB and metabolites, a non-compartment model for extravascular input will be used. For calculation of AUC and AUMC the linear trapezoid rule will be applied for the ascending part of the concentraion-time curve and the log-linear trapezoidal rule for the descending part of the concentration-time curve.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['colorectal carcinoma', 'K-ras wild type', 'Capecitabine', 'Cetuximab', 'Oxaliplatin', 'Pharmacokinetics', 'exclude a possible influence of CETUX', 'plasma disposition', 'metabolic activation', 'CCB', 'OxPt'], 'conditions': ['Metastatic Colorectal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.agmt.at', 'label': 'Sponsor'}]}, 'descriptionModule': {'briefSummary': 'The objective of this pharmacokinetic study is to exclude a possible influence of CETUX on the plasma disposition and metabolic activation of Capecitabine (CCB) and when this regimen is given combined with Oxaliplatin (OxPt).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria selected:\n\n* signed written informed consent\n* male or female \\> 18 years\n* K-ras wild type adenocarcinoma of the colon or rectum\n* metastatic colorectal carcinoma\n* ECOG \\<= 2\n\nExclusion Criteria selected:\n\n* brain metastasis\n* previous chemotherapy\n* stage 3 or 4 heart failure\n* uncontrolled angina\n* pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT01579357', 'briefTitle': 'Pharmacokinetics and Metabolic Activation of Capecitabine', 'organization': {'class': 'OTHER', 'fullName': 'Arbeitsgemeinschaft medikamentoese Tumortherapie'}, 'officialTitle': 'Pharmacokinetics and Metabolic Activation of Capecitabine When Given Concomitantly With Oxaliplatin and the Monoclonal Antibody Cetuximab', 'orgStudyIdInfo': {'id': 'AGMT-Capecet_PK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A', 'description': 'Capecitabine in week 1,2,4,5,7 and 8 Cetuximab in week 3 to 9 Oxaliplatin in week 7', 'interventionNames': ['Other: blood samples']}, {'type': 'OTHER', 'label': 'B', 'description': 'Capecitabine in weeks 1,2,4,5,7, and 8 Cetuximab in weeks 1,8 and 9 Oxaliplatin in week 7', 'interventionNames': ['Other: blood samples']}], 'interventions': [{'name': 'blood samples', 'type': 'OTHER', 'description': 'Draw blood samples in week 1 (day 1 and day 5), in week 4 (day 1 and day 5) and in week 7 (day 1 and day 5).\n\nday 1: pre dose, 30,60,90,120,150,180,240,300 and 360min day 5: pre dose, 30,60,90,120min', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Salzburg', 'state': 'Salzburg', 'country': 'Austria', 'facility': 'PMU Salzburg', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'AKH Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1100', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Kaiser Franz Josef Spital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arbeitsgemeinschaft medikamentoese Tumortherapie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-06-19', 'type': 'RELEASE'}, {'date': '2017-11-01', 'type': 'RESET'}, {'date': '2017-12-06', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2019-01-08', 'type': 'RELEASE'}, {'date': '2019-01-21', 'type': 'UNRELEASE'}, {'date': '2019-01-21', 'type': 'RELEASE'}, {'date': '2019-04-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Arbeitsgemeinschaft medikamentoese Tumortherapie'}}}}