Raw JSON
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'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA ver18.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA ver18.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA ver18.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA ver18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA ver18.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA ver18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA ver18.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA ver18.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA ver18.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA ver18.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA ver18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA ver18.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax (Maximum Plasma Concentration) of FTD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAS-102', 'description': 'TAS-102: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '3019.49', 'spread': '34.0', 'groupId': 'OG000'}]}]}, {'title': 'Day 12', 'categories': [{'measurements': [{'value': '3693.08', 'spread': '21.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Multiple time points on Day 1 and Day 12 of Cycle 1.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Tmax (Time to Reach Maximum Drug Concentration in Blood) of FTD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAS-102', 'description': 'TAS-102: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '1.00', 'spread': '58.7', 'groupId': 'OG000'}]}]}, {'title': 'Day 12', 'categories': [{'measurements': [{'value': '2.61', 'spread': '36.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Multiple time points on Day 1 and Day 12 of Cycle 1.', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'AUC0-t (Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time (t) of the Last Quantifiable Concentration ) of FTD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAS-102', 'description': 'TAS-102: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '7796.60', 'spread': '19.1', 'groupId': 'OG000'}]}]}, {'title': 'Day 12', 'categories': [{'measurements': [{'value': '18181.34', 'spread': '30.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Multiple time points on Day 1 and Day 12 of Cycle 1.', 'unitOfMeasure': 'ng·hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TAS-102', 'description': 'TAS-102: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'TAS-102', 'description': 'TAS-102: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.0', 'groupId': 'BG000', 'lowerLimit': '35', 'upperLimit': '64'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2014-09-30', 'resultsFirstSubmitDate': '2024-08-01', 'studyFirstSubmitQcDate': '2014-10-06', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-01', 'studyFirstPostDateStruct': {'date': '2014-10-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax (Maximum Plasma Concentration) of FTD', 'timeFrame': 'Multiple time points on Day 1 and Day 12 of Cycle 1.'}, {'measure': 'Tmax (Time to Reach Maximum Drug Concentration in Blood) of FTD', 'timeFrame': 'Multiple time points on Day 1 and Day 12 of Cycle 1.'}, {'measure': 'AUC0-t (Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time (t) of the Last Quantifiable Concentration ) of FTD', 'timeFrame': 'Multiple time points on Day 1 and Day 12 of Cycle 1.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Advanced or Metastatic Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '32308505', 'type': 'DERIVED', 'citation': 'Wang X, Zhou J, Li Y, Ge Y, Zhou Y, Bai C, Shen L. Pharmacokinetics, Safety, and Preliminary Efficacy of Oral Trifluridine/Tipiracil in Chinese Patients with Solid Tumors: A Phase 1b, Open-Label Study. Clin Pharmacol. 2020 Apr 9;12:21-33. doi: 10.2147/CPAA.S232104. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the pharmacokinetics of TAS-102 after single and multiple dose in Chinese patients with solid tumor.', 'detailedDescription': 'This is an open-label, non-randomized, single group Phase 1 study of TAS-102, evaluating the pharmacokinetics, safety, and antitumor activity. Blood sampling will be performed during the first cycle (Day1 and Day 12) of therapy in all consenting patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Has provided written informed consent prior to performance of any study procedure.\n* 2\\. Has definitive histologically or cytologically confirmed advanced or metastatic solid tumor.\n* 3\\. Is able to take medications orally.\n* 4\\. Has adequate organ function (bone marrow, kidney and liver).\n* 5\\. Has Eastern Cooperative Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* 1\\. Has received TAS-102.\n* 2\\. Has suffered serious complications.\n* 3\\. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies.\n* 4\\. Has had prior gastrectomy.\n* 5\\. Is a pregnant or lactating female or male who refused using birth control during the clinical trial period and within 6 months after discontinuation of study treatment.'}, 'identificationModule': {'nctId': 'NCT02261532', 'briefTitle': 'A Phase I Study of TAS-102 in Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taiho Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase 1, OPEN-Label, Non-randomized, Pharmacokinetic Study of TAS-102 in Chinese Patients With Solid Tumors', 'orgStudyIdInfo': {'id': '10040100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAS-102', 'interventionNames': ['Drug: TAS-102']}], 'interventions': [{'name': 'TAS-102', 'type': 'DRUG', 'description': 'TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.', 'armGroupLabels': ['TAS-102']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Taiho Pharmaceutical Co., Ltd selected site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taiho Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}