Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 1:54 PM
Study NCT ID:
NCT01213160
Status:
COMPLETED
Last Update Posted:
2016-06-29
First Post:
2010-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C572463', 'term': 'AZD4547'}]}}, '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': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-28', 'studyFirstSubmitDate': '2010-09-30', 'studyFirstSubmitQcDate': '2010-09-30', 'lastUpdatePostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of adverse events (based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)general examination', 'timeFrame': 'General examination prior to IP administration in treatment cycles'}, {'measure': 'Assessment of adverse events (based on CTCAE version 4.0)general examination', 'timeFrame': 'General examination on day 1 in cycle 0'}, {'measure': 'Assessment of adverse events (based on CTCAE version 4.0)general examination', 'timeFrame': 'General examination day 21 in cycle 1.'}, {'measure': 'Assessment of adverse events (based on CTCAE version 4.0), laboratory values', 'timeFrame': 'Laboratory assessment prior to IP administration in all treatment cycles'}, {'measure': 'Assessment of adverse events (based on CTCAE version 4.0), laboratory values', 'timeFrame': 'Laboratory assessment on day 1 in cycle 0'}, {'measure': 'Assessment of adverse events (based on CTCAE version 4.0), laboratory values', 'timeFrame': 'Laboratory assessment day 1 cycle 1.'}, {'measure': 'Assessment of adverse events (based on CTCAE version 4.0), laboratory values', 'timeFrame': 'Laboratory assessment day 8 cycle 1.'}, {'measure': 'Assessment of adverse events (based on CTCAE version 4.0), laboratory values', 'timeFrame': 'Laboratory assessment day 15 cycle 1.'}, {'measure': 'Assessment of adverse events (based on CTCAE version 4.0), laboratory values', 'timeFrame': 'Laboratory assessment day 21 cycle 1.'}, {'measure': 'Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements', 'timeFrame': 'Vital sign measurements prior to IP administration in all treatment cycles'}, {'measure': 'Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements', 'timeFrame': 'Vital sign measurements day 1 in cycle 0'}, {'measure': 'Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements', 'timeFrame': 'Vital sign measurements day 2 in cycle 0'}, {'measure': 'Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements', 'timeFrame': 'Vital sign measurements day 8 in cycle 1.'}, {'measure': 'Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements', 'timeFrame': 'Vital sign measurements day 21 in cycle 1.'}, {'measure': 'Assessment of adverse events (based on CTCAE version 4.0), left ventricular ejection fraction (LVEF)', 'timeFrame': 'LVEF prior to study administration'}, {'measure': 'Assessment of adverse events (based on CTCAE version 4.0), LVEF', 'timeFrame': 'LVEF on day 21 in cycle 1.'}, {'measure': 'Assessment of adverse events (based on CTCAE version 4.0), eye examination', 'timeFrame': 'Eye examination prior to study administration'}, {'measure': 'Assessment of adverse events (based on CTCAE version 4.0), eye examination', 'timeFrame': 'Eye examination on day 21 in cycle 1.'}], 'secondaryOutcomes': [{'measure': 'Define the maximum tolerated dose (MTD) if possible or biological effective dose.', 'timeFrame': 'Up to 3 weeks'}, {'measure': 'To explore the pharmacokinetics (PK) of AZD4547and metabolite in Japanese patients with advanced solid malignancies when given AZD4547 orally.', 'timeFrame': 'Schedule of PK assessment 1. AZD4547; blood Cycle0-day1 -day21; 27 point 2. AZD4547 metabolite; blood Cycle1-day21; 1 poin 3. AZD4547; urine Cycle1-day21; 1 point'}, {'measure': 'To obtain a preliminary assessment of the anti-tumour effect of AZD4547 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) criteria v1.1.', 'timeFrame': 'Schedule of CT/MRI etc-screeing-cycle1 day21-every 6 weeks-the end of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Phase I', 'cancer', 'solid tumours', 'advanced solid malignancies', 'dose escalation', 'FGFR TKI', 'Japanese'], 'conditions': ['Cancer', 'Advanced Solid Malignancies']}, 'referencesModule': {'references': [{'pmid': '28070720', 'type': 'DERIVED', 'citation': 'Saka H, Kitagawa C, Kogure Y, Takahashi Y, Fujikawa K, Sagawa T, Iwasa S, Takahashi N, Fukao T, Tchinou C, Landers D, Yamada Y. Safety, tolerability and pharmacokinetics of the fibroblast growth factor receptor inhibitor AZD4547 in Japanese patients with advanced solid tumours: a Phase I study. Invest New Drugs. 2017 Aug;35(4):451-462. doi: 10.1007/s10637-016-0416-x. Epub 2017 Jan 10.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1282&filename=D2610C00002_CSR_Synopsis.pdf', 'label': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to explore the safety and tolerability of AZD4547 in Japanese patients with advanced solid malignancies.', 'detailedDescription': 'A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD4547 in Japanese Patients with Advanced Solid Malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '150 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Japanese patients with advanced solid malignancies Over 25 years old Relatively good overall health other than cancer\n\nExclusion Criteria:\n\n\\- Poor bone marrow function (not producing enough blood cells). Poor liver or kidney function. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the IP or previous significant bowel resection.'}, 'identificationModule': {'nctId': 'NCT01213160', 'briefTitle': 'Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD4547 in Japanese Patients With Advanced Solid Malignancies', 'orgStudyIdInfo': {'id': 'D2610C00002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD4547', 'interventionNames': ['Drug: AZD4547']}], 'interventions': [{'name': 'AZD4547', 'type': 'DRUG', 'description': 'film coated tablet, PO, twice daily', 'armGroupLabels': ['AZD4547']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chūōku', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.63867, 'lon': 130.67068}}, {'city': 'Nagoya', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Sapporo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}], 'overallOfficials': [{'name': 'Paul Stockman', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Hideo Saka, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Hospital Organisation Nagoya Medical Centre'}, {'name': 'Yasuo Takahashi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Hospital OrganisationHokkaido Cancer Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}