Viewing Study NCT00979134

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-25 @ 2:32 AM
Ignite Modification Date: 2026-03-08 @ 4:13 AM
Study NCT ID: NCT00979134
Status: TERMINATED
Last Update Posted: 2019-03-15
First Post: 2009-09-16
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C572463', 'term': 'AZD4547'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Donal.Landers@astrazeneca.com', 'phone': '+44 1625 231890', 'title': 'Donal Landers', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to early termination no AUC(inf), Cmax, Css,max and AUC,ss for Part C (PK). Data from 33 patients after 22 days of multiple dosing in Part A \\& limited data for part B only.\n\n1 subject not dosed, so pre-stated subject number 95, total with data 94.'}}, 'adverseEventsModule': {'timeFrame': 'AEs were collected on a continual basis from Screening up until the end of the 28 day follow up period.', 'eventGroups': [{'id': 'EG000', 'title': 'Part B', 'description': 'Dose expansion phase (80mg bd tablet)', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Part C (FISH Ratio >= 2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours', 'otherNumAtRisk': 33, 'otherNumAffected': 33, 'seriousNumAtRisk': 33, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'Part C (FISH Ratio < 2)', 'description': 'Dose expansionj in patients with FGFR gene-amplified tumours', 'otherNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Part A', 'description': 'Dose escalation', 'otherNumAtRisk': 43, 'otherNumAffected': 43, 'seriousNumAtRisk': 43, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Stomatis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Hyperphosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Breath sounds abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Ageusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'ALT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}], 'seriousEvents': [{'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'ALT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'GGT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Pelvi-ureteric obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Tumour associated fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Chorioretinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Bile duct obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Euthanasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1.'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'AUC(0-infinity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Dose expansion phase (80mg bd tablet)'}, {'id': 'OG001', 'title': 'Part C (FISH Ratio >= 2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'OG002', 'title': 'Part C (FISH Ratio < 2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'OG003', 'title': 'Part A', 'description': 'Dose escalation'}], 'classes': [{'categories': [{'measurements': [{'value': '1818', 'spread': '59.43', 'groupId': 'OG000'}, {'value': '2697', 'spread': '110.8', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'PK samples out to 96 hours "0 to 96 hours post-dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.', 'description': 'To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK'}, {'type': 'SECONDARY', 'title': 'Tumour Response (Best Objective Response) - Number of Patients With a Confirmed Response of Partial Response (PR) or Confirmed Response (CR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Dose expansion phase (80mg bd tablet)'}, {'id': 'OG001', 'title': 'Part C (FISH Ratio >= 2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'OG002', 'title': 'Part A', 'description': 'Dose escalation'}, {'id': 'OG003', 'title': 'Part C (FISH Ratio < 2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline assessment, then assessment every 6 weeks after start of treatment until objective disease progression.', 'description': 'To obtain a preliminary assessment of the anti tumour activity of AZD4547 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1. Objective response = CR + PR; CR=disappearance of all target lesions and PR is \\>=30% reduction in sum of longest diameter of target lesions', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy/Tumour response: All dosed patients meeting the final FISH 6 score criteria with a baseline tumour assessment and had a FGFR1 FISH ratio ≥2 if the patient was from Part C'}, {'type': 'SECONDARY', 'title': 'Cmax (ng/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Dose expansion phase (80mg bd tablet)'}, {'id': 'OG001', 'title': 'Part C (FISH Ratio >= 2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'OG002', 'title': 'Part A', 'description': 'Dose escalation'}, {'id': 'OG003', 'title': 'Part C (FISH Ratio < 2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}], 'classes': [{'categories': [{'measurements': [{'value': '112.0', 'spread': '81.47', 'groupId': 'OG000'}, {'value': '167.4', 'spread': '112.1', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'PK samples out to 96 hours "0-96 hours post dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.', 'description': 'To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK'}, {'type': 'SECONDARY', 'title': 'Css,Max (ng/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Dose expansion phase (80mg bd tablet)'}, {'id': 'OG001', 'title': 'Part C (FISH Ratio >= 2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'OG002', 'title': 'Part A', 'description': 'Dose escalation'}, {'id': 'OG003', 'title': 'Part C (FISH Ratio < 2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}], 'classes': [{'categories': [{'measurements': [{'value': '289.3', 'spread': '45.98', 'groupId': 'OG000'}, {'value': '297.1', 'spread': '123.5', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'PK samples out to 96 hours "0-96 hours post-dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.', 'description': 'To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK'}, {'type': 'SECONDARY', 'title': 'AUC,ss(0-infinity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Dose expansion phase (80mg bd tablet)'}, {'id': 'OG001', 'title': 'Part C (FISH Ratio >= 2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'OG002', 'title': 'Part C (FISH Ratio < 2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'OG003', 'title': 'Part A', 'description': 'Dose escalation'}], 'classes': [{'categories': [{'measurements': [{'value': '2606', 'spread': '41.32', 'groupId': 'OG000'}, {'value': '2337', 'spread': '125.2', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'PK samples out to 96 hours "0-96 hours post dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.', 'description': 'To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK'}, {'type': 'PRIMARY', 'title': 'Number of Patients Who Experienced at Least 1 AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Dose expansion phase (80mg bd tablet)'}, {'id': 'OG001', 'title': 'Part C (FISH Ratio >= 2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'OG002', 'title': 'Part C (FISH Ratio <2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'OG003', 'title': 'Part A', 'description': 'Dose escalation'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'AEs are monitored from screenng through to 30 day follow up period', 'description': 'To investigate the safety and tolerability of AZD4547. System organ class (SOC), preferred term (PT), duration and severity all recorded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced at Least 1 Causally Related AE.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Dose expansion phase (80mg bd tablet)'}, {'id': 'OG001', 'title': 'Part C (FISH Ratio >= 2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'OG002', 'title': 'Part C (FISH Ratio <2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'OG003', 'title': 'Part A', 'description': 'Dose escalation'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'AEs are continually assessed from screening up to 30 day FU period', 'description': 'To investigate the safety and tolerability of AZD4547. A causally related AE is an AE deemed to be causally related to AZD4547.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With at Least 1 AE of CTCAE >=G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Dose expansion phase (80mg bd tablet)'}, {'id': 'OG001', 'title': 'Part C (FISH Ratio >= 2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'OG002', 'title': 'Part C (FISH Ratio <2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'OG003', 'title': 'Part A', 'description': 'Dose escalation'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Ongoing up to discontinuation up to 30 day FU.', 'description': 'To investigate the safety and tolerability of AZD4547', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With at Least 1 Causally Related AE of CTCAE >=G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Dose expansion phase (80mg bd tablet)'}, {'id': 'OG001', 'title': 'Part C (FISH Ratio >= 2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'OG002', 'title': 'Part C (FISH Ratio <2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'OG003', 'title': 'Part A', 'description': 'Dose escalation'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Ongoing up to discontinuation up to 30 day FU.', 'description': 'To investigate the safety and tolerability of AZD4547', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced at Least One SAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Dose expansion phase (80mg bd tablet)'}, {'id': 'OG001', 'title': 'Part C (FISH Ratio >= 2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'OG002', 'title': 'Part C (FISH Ratio <2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'OG003', 'title': 'Part A', 'description': 'Dose escalation'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Serious Adverse Events (SAEs) are continually assessed from Screening up to the end of the 30 day FU period.', 'description': 'To investigate the safety and tolerability of AZD4547. A SAE (Serious Adverse Event) is and AE (adverse Event) which fulfills one of the following criteria that the PI assesses closely such as results in death, immediately life-threatening, requires hospitalisation or prolongation of, results in significant disability, results in birth defect, may jepardise the patient or require intervention to prevent any of the previous outcomes.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With at Least 1 Causally Related SAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Dose expansion phase (80mg bd tablet)'}, {'id': 'OG001', 'title': 'Part C (FISH Ratio >= 2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'OG002', 'title': 'Part C (FISH Ratio <2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'OG003', 'title': 'Part A', 'description': 'Dose escalation'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'SAEs are continually monitored from screening to end of 30 FU period', 'description': 'To investigate the safety and tolerability of AZD4547: SAEs are assessed and deemed as causally related or not to AZD4547', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A', 'description': 'Dose escalation'}, {'id': 'FG001', 'title': 'Part B', 'description': 'Dose expansion phase (80mg bd tablet)'}, {'id': 'FG002', 'title': 'Part C', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'At DCO', 'groupId': 'FG000', 'numSubjects': '10'}, {'comment': 'At DCO', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'At DCO', 'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '26'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'First patient enrolled: 21 October 2009 and last patient enrolled: 13 December 2013. This was a multicentre study conducted at a total of 29 centres in 7 countries.', 'preAssignmentDetails': 'In Parts A and B, a single dose was followed by a Washout Period of 5 to 10 days before multiple dosing commenced.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Part B', 'description': 'Dose expansion phase (80mg bd tablet)'}, {'id': 'BG001', 'title': 'Part C (FISH Ratio >= 2)', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'BG002', 'title': 'Part C (FISH Ratio < 2 )', 'description': 'Dose expansion in patients with FGFR gene-amplified tumours'}, {'id': 'BG003', 'title': 'Part A', 'description': 'Dose escalation'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.7', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '59.5', 'spread': '10.82', 'groupId': 'BG001'}, {'value': '58.2', 'spread': '11.77', 'groupId': 'BG002'}, {'value': '55.8', 'spread': '10.1', 'groupId': 'BG003'}, {'value': '57.59', 'spread': '10.57', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'whyStopped': 'Termination of study enrolment to Part C, Cohort 3 (08 July 2013) was based on the analysis of data from Study D2610C00004.\n\nData were available from 33 patient', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2015-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-30', 'studyFirstSubmitDate': '2009-09-16', 'resultsFirstSubmitDate': '2016-04-01', 'studyFirstSubmitQcDate': '2009-09-16', 'lastUpdatePostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-30', 'studyFirstPostDateStruct': {'date': '2009-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Who Experienced at Least 1 AE', 'timeFrame': 'AEs are monitored from screenng through to 30 day follow up period', 'description': 'To investigate the safety and tolerability of AZD4547. System organ class (SOC), preferred term (PT), duration and severity all recorded.'}, {'measure': 'Number of Participants Who Experienced at Least 1 Causally Related AE.', 'timeFrame': 'AEs are continually assessed from screening up to 30 day FU period', 'description': 'To investigate the safety and tolerability of AZD4547. A causally related AE is an AE deemed to be causally related to AZD4547.'}, {'measure': 'Number of Participants With at Least 1 AE of CTCAE >=G3', 'timeFrame': 'Ongoing up to discontinuation up to 30 day FU.', 'description': 'To investigate the safety and tolerability of AZD4547'}, {'measure': 'Number of Participants With at Least 1 Causally Related AE of CTCAE >=G3', 'timeFrame': 'Ongoing up to discontinuation up to 30 day FU.', 'description': 'To investigate the safety and tolerability of AZD4547'}, {'measure': 'Number of Participants Who Experienced at Least One SAE', 'timeFrame': 'Serious Adverse Events (SAEs) are continually assessed from Screening up to the end of the 30 day FU period.', 'description': 'To investigate the safety and tolerability of AZD4547. A SAE (Serious Adverse Event) is and AE (adverse Event) which fulfills one of the following criteria that the PI assesses closely such as results in death, immediately life-threatening, requires hospitalisation or prolongation of, results in significant disability, results in birth defect, may jepardise the patient or require intervention to prevent any of the previous outcomes.'}, {'measure': 'Number of Participants With at Least 1 Causally Related SAE', 'timeFrame': 'SAEs are continually monitored from screening to end of 30 FU period', 'description': 'To investigate the safety and tolerability of AZD4547: SAEs are assessed and deemed as causally related or not to AZD4547'}], 'secondaryOutcomes': [{'measure': 'AUC(0-infinity)', 'timeFrame': 'PK samples out to 96 hours "0 to 96 hours post-dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.', 'description': 'To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.'}, {'measure': 'Tumour Response (Best Objective Response) - Number of Patients With a Confirmed Response of Partial Response (PR) or Confirmed Response (CR)', 'timeFrame': 'Baseline assessment, then assessment every 6 weeks after start of treatment until objective disease progression.', 'description': 'To obtain a preliminary assessment of the anti tumour activity of AZD4547 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1. Objective response = CR + PR; CR=disappearance of all target lesions and PR is \\>=30% reduction in sum of longest diameter of target lesions'}, {'measure': 'Cmax (ng/mL)', 'timeFrame': 'PK samples out to 96 hours "0-96 hours post dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.', 'description': 'To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.'}, {'measure': 'Css,Max (ng/mL)', 'timeFrame': 'PK samples out to 96 hours "0-96 hours post-dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.', 'description': 'To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.'}, {'measure': 'AUC,ss(0-infinity)', 'timeFrame': 'PK samples out to 96 hours "0-96 hours post dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.', 'description': 'To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer', 'Tumour', 'Advanced Solid Malignancies', 'FGFR', 'Squamous NSCLC', 'Gastric adenocarcinoma'], 'conditions': ['Cancer', 'Advanced Solid Malignancies']}, 'descriptionModule': {'briefSummary': 'This study is primarily designed to assess the safety and tolerability of AZD4547 at increasing doses in patients with advanced solid malignancies and for whom no standard medication options are available. It also assesses the blood levels and action of AZD4547 in the body over a period of time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '149 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum life expectancy of 12 weeks\n* The presence of a solid, malignant tumour that is resistance to standard therapies or for which no standard therapies exist\n* In the expansion for the study patients must have a tumour at least 1cm in size that can be measure using a CT or MRI scan, and provide a tumour sample to the sponsor company for testing of FGFR1 and/or 2 amplification\n* Expansion, 5 groups of advanced cancer\n* Solid tumours,FGFR1 and/or FGFR2 gene amplified\n* Squamous NSCLC, FGFR1 gene low \\& high amplified\n* Gastric adenocarcinoma, including the lower oesophagus/gastro-oesophageal junction, FGFR2 gene low \\& high amplified\n* Aged at least 25 years\n\nExclusion Criteria:\n\n* Treatment with any other chemotherapy, immunotherapy or anticancer agents within 3 weeks before the first dose of study\n* An inability to be able to take the study medication\n* A bad reaction to AZD4547 or any drugs similar to it in structure or class.'}, 'identificationModule': {'nctId': 'NCT00979134', 'briefTitle': 'Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours', '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 Patients With Advanced Solid Malignancies', 'orgStudyIdInfo': {'id': 'D2610C00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A', 'description': 'Ascending doses of AZD4547 administered orally to patients to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD)', 'interventionNames': ['Drug: AZD4547']}, {'type': 'EXPERIMENTAL', 'label': 'Part B', 'description': 'Dose expansion phase, at the RD defined in Part A', 'interventionNames': ['Drug: AZD4547']}, {'type': 'EXPERIMENTAL', 'label': 'Part C', 'description': 'Expansion phase in patients with FGFR1 and FGFR2 amplified tumours commencing at the RD defined from Part A', 'interventionNames': ['Drug: AZD4547']}], 'interventions': [{'name': 'AZD4547', 'type': 'DRUG', 'description': 'Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily', 'armGroupLabels': ['Part B']}, {'name': 'AZD4547', 'type': 'DRUG', 'description': 'Patients start at a dose of 80 mg twice daily, with no washout', 'armGroupLabels': ['Part C']}, {'name': 'AZD4547', 'type': 'DRUG', 'description': 'Single dose is followed by washout 5-10 days before multiple dose', 'armGroupLabels': ['Part A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '50924', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '60488', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '20089', 'city': 'Rozzano', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3015 CE', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '06008', 'city': 'Badajoz', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'zip': '28222', 'city': 'Majadahonda', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'B9 5SS', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'EH4 2XU', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'G12 0YN', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'W12 0NN', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W1G 6AD', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'WV10 0QP', 'city': 'Wolverhampton', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}], 'overallOfficials': [{'name': 'Fabrice André, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de cancérologie Gustave Roussy'}, {'name': 'Donal Landers, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}