Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT01286467
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2011-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study Of PF-04449913 Administered Alone In Select Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000592580', 'term': 'glasdegib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Abdominal rigidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Parotid gland inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Electrocardiogram QT interval abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 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{'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Peritonitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With First Cycle Dose Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of Cycle 1 (Study Day 28)', 'description': 'Any DLT event in Cycle 1: (1) Grade 4 neutropenia lasting more than 7 days; (2) Febrile neutropenia; (3) Grade \\>=3 neutropenic infection; (4) Grade \\>=3 thrombocytopenia with bleeding; (5) Grade 4 thrombocytopenia lasting more than 7 days; (6) Grade \\>=3 non-hematologic toxicity; (7) Failure to deliver at least 80% of the planned doses due to toxicities attributable to PF-04449913', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Analysis Set: all enrolled participants who received at least 1 dose of study medication and did not have major treatment deviations during Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-emergent Adverse Events (AEs), by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.0) Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'classes': [{'title': 'Any AEs, Grade 1', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Any AEs, Grade 2', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}, {'value': '12.5', 'groupId': 'OG003'}]}]}, {'title': 'Any AEs, Grade 3', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}, {'value': '87.5', 'groupId': 'OG003'}]}]}, {'title': 'Any AEs, Grade 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Any AEs, Grade 5', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Any AEs, Total', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days post last dose of study medication (maximum duration: 14 cycles [each cycle of 28 days])', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the worst CTCAE grade was reported. Grades as per NCI CTCAE, v4.0 were classified as: Grade 1- mild, Grade 2- moderate, Grade 3- severe, Grade 4- life threatening, and Grade 5- death.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all enrolled participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-related AEs, by NCI CTCAE (Version 4.0) Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'classes': [{'title': 'Any AEs, Grade 1', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Any AEs, Grade 2', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}]}]}, {'title': 'Any AEs, Grade 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '62.5', 'groupId': 'OG003'}]}]}, {'title': 'Any AEs, Grade 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Any AEs, Grade 5', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Any AEs, Total', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '87.5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days post last dose of study medication (maximum duration: 14 cycles [each cycle of 28 days])', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-related AEs are events that were assessed by the investigator as related to study medication. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the worst CTCAE grade was reported. Grades as per NCI CTCAE, v4.0 were classified as: Grade 1- mild, Grade 2- moderate, Grade 3- severe, Grade 4- life threatening, and Grade 5- death.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all enrolled participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Hedgehog Biomarker Modulation: Relative GLI1 Gene Expression (Ratio) to Baseline for Normal Skin on Cycle 1/Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.04', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.06', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Cycle 1/Day 15', 'description': 'Ribonucleic acid (RNA) was extracted from skin samples and complementary deoxyribonucleic acid (cDNA) was prepared. Gene expression was measured using custom Taqman low density array (TLDA) cards run on the Applied Biosystems ViiATM 7 system. The ratio for each participant at each dosing level was calculated at C1D15 to baseline assay readout (C1D1), and the mean of it is reported in this outcome measure.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic (PD) Analysis Set: all enrolled participants who received at least 1 dose of study medication, and had baseline and at least 1 on-treatment PD result.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) on Cycle 1/Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '1161', 'spread': '389', 'groupId': 'OG000'}, {'value': '1126', 'spread': '949', 'groupId': 'OG001'}, {'value': '2624', 'spread': '611', 'groupId': 'OG002'}, {'value': '6299', 'spread': '2661', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1', 'description': 'Cmax of PF-04449913 on Cycle 1/Day 1 has been reported.', 'unitOfMeasure': 'nanogram/milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) on Cycle 1/Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '1373', 'spread': '542', 'groupId': 'OG000'}, {'value': '1567', 'spread': '475', 'groupId': 'OG001'}, {'value': '3363', 'spread': '1716', 'groupId': 'OG002'}, {'value': '4913', 'spread': '992', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25', 'description': 'Cmax of PF-04449913 on Cycle 1/Day 25 has been reported.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) on Cycle 1/Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2.2'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1', 'description': 'Tmax of PF-04449913 on Cycle 1/Day 1 has been reported.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) on Cycle 1/Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '10'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25', 'description': 'Tmax of PF-04449913 on Cycle 1/Day 25 has been reported.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Cycle 1/Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '10510', 'spread': '3948', 'groupId': 'OG000'}, {'value': '12540', 'spread': '8583', 'groupId': 'OG001'}, {'value': '31160', 'spread': '11140', 'groupId': 'OG002'}, {'value': '62550', 'spread': '18031', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1', 'description': 'AUCtau of PF-04449913 on Cycle 1/Day 1 has been reported. AUCtau is defined as area under the curve from time 0 to tau, where tau is the dosing interval of 24 hours.', 'unitOfMeasure': 'nanogram*hour/milliliter (ng*hr/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Cycle 1/Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '13930', 'spread': '6967', 'groupId': 'OG000'}, {'value': '18670', 'spread': '5050', 'groupId': 'OG001'}, {'value': '46670', 'spread': '20336', 'groupId': 'OG002'}, {'value': '70600', 'spread': '19636', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25', 'description': 'AUCtau of PF-04449913 on Cycle 1/Day 25 has been reported. AUCtau is defined as area under the curve from time 0 to tau, where tau is the dosing interval of 24 hours.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure'}, {'type': 'SECONDARY', 'title': 'Plasma Decay Half-life (t1/2) on Cycle 1/Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'spread': '5', 'groupId': 'OG000'}, {'value': '21', 'spread': '6.7', 'groupId': 'OG001'}, {'value': '21', 'spread': '4.9', 'groupId': 'OG002'}, {'value': '18', 'spread': '4.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure'}, {'type': 'SECONDARY', 'title': 'Apparent Oral Clearance (CL/F) on Cycle 1/Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '8.0', 'spread': '3.5', 'groupId': 'OG002'}, {'value': '9.6', 'spread': '2.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.', 'unitOfMeasure': 'liter/hour (L/hr)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution (Vz/F) on Cycle 1/Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '182', 'spread': '69', 'groupId': 'OG000'}, {'value': '286', 'spread': '146', 'groupId': 'OG001'}, {'value': '234', 'spread': '93', 'groupId': 'OG002'}, {'value': '249', 'spread': '88', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.', 'unitOfMeasure': 'liter (L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio (Rac) on Cycle 1/Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.6'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '4.4'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '2.9'}, {'value': '1.6', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '1.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1, and pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25', 'description': 'Accumulation ratio was calculated as AUCtau at steady state (Cycle 1/Day 25)/AUCtau on Study Day 1', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure'}, {'type': 'SECONDARY', 'title': 'Average Concentration at Steady State (Cavg) on Cycle 1/Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '580', 'spread': '290', 'groupId': 'OG000'}, {'value': '777', 'spread': '211', 'groupId': 'OG001'}, {'value': '1942', 'spread': '848', 'groupId': 'OG002'}, {'value': '2943', 'spread': '820', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure'}, {'type': 'SECONDARY', 'title': "Number of Participants With Increase From Baseline in Corrected QT Using Fridericia's Formula (QTcF) Interval", 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'classes': [{'title': 'QTcF, maximum increase from baseline: <30 msec', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'QTcF, maximum increase from baseline: 30-<60 msec', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'QTcF, maximum increase from baseline: >=60 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Cycle 14 (each cycle 28 days)', 'description': "Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole (QT) was corrected for heart rate (QTc). QTc using Fridericia's formula (QTcF) was calculated. Participants with maximum increase from baseline of less than (\\<) 30 millisecond (msec), 30 to \\<60 msec and \\>=60 msec were summarized.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'QTc Analysis Set: all enrolled participants who had at least 1 ECG assessment after receiving at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Decrease From Baseline in QTcF Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'classes': [{'title': 'QTcF, maximum decrease from baseline: <30 msec', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'QTcF, maximum decrease from baseline: 30-<60 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'QTcF, maximum decrease from baseline: >=60 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Cycle 14 (each cycle 28 days)', 'description': 'Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QTcF was calculated. Participants with maximum decrease from baseline of \\<30 msec, 30 to \\<60 msec and \\>=60 msec were summarized.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'QTc Analysis Set: all enrolled participants who had at least 1 ECG assessment after receiving at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Post-baseline QTcF Interval Greater Than or Equal to 500 Msec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Cycle 14 (each cycle 28 days)', 'description': 'Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. Participants with post-baseline absolute QTcF values \\>=500 msec were summarized.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'QTc Analysis Set: all enrolled participants who had at least 1 ECG assessment after receiving at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '41.0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '36.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Cycle 14 (each cycle 28 days)', 'description': 'Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as \\>=30% decrease under baseline of the sum of diameters of all target measurable lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Set: all enrolled participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'timeFrame': 'Baseline up to Cycle 14 (each cycle 28 days)', 'description': 'Time from Cycle 1/Day 1 to first documentation of disease progression or to death due to any cause, whichever occurred first. Progression was defined using RECIST 1.1 as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. PFS (days) was calculated as (first event date minus the date of first dose of study medication plus 1).', 'reportingStatus': 'POSTED', 'populationDescription': 'This OM was planned for expansion cohort only. Since none of the participants were enrolled in expansion cohort, no data was collected for progression free survival and thus the outcome measure was not performed.'}, {'type': 'SECONDARY', 'title': 'Time to Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'timeFrame': 'Baseline up to Cycle 14 (each cycle 28 days)', 'description': 'Time from Cycle 1/Day 1 to first documentation of disease progression. Progression was defined using RECIST 1.1 as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. TTP (days) was calculated as (first event date minus the date of first dose of study medication plus 1).', 'reportingStatus': 'POSTED', 'populationDescription': 'This OM was planned for expansion cohort only. Since none of the participants were enrolled in expansion cohort, no data was collected for time to progression and thus the outcome measure was not performed.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'OG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'timeFrame': 'Baseline up to Cycle 14 (each cycle 28 days)', 'description': 'Duration from date of first documentation of objective response to date of first documentation of disease progression or death. Progression was defined using RECIST 1.1 as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. DR was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first objective response that was subsequently confirmed plus 1).', 'reportingStatus': 'POSTED', 'populationDescription': 'This OM was planned for expansion cohort only. Since none of the participants were enrolled in expansion cohort, no data was collected for duration of response and thus the outcome measure was not performed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'FG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'FG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'FG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Study drug stop longer than 14 days', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'All enrolled participants were assigned to PF-04449913 dose escalation cohorts.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'BG001', 'title': 'PF-04449913 160 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'BG002', 'title': 'PF-04449913 320 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'BG003', 'title': 'PF-04449913 640 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '18 to 44 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': '45 to 64 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'Greater than or equal to (>=) 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All enrolled participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2012-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-09', 'studyFirstSubmitDate': '2011-01-14', 'resultsFirstSubmitDate': '2022-08-19', 'studyFirstSubmitQcDate': '2011-01-27', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-09', 'studyFirstPostDateStruct': {'date': '2011-01-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With First Cycle Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Baseline up to end of Cycle 1 (Study Day 28)', 'description': 'Any DLT event in Cycle 1: (1) Grade 4 neutropenia lasting more than 7 days; (2) Febrile neutropenia; (3) Grade \\>=3 neutropenic infection; (4) Grade \\>=3 thrombocytopenia with bleeding; (5) Grade 4 thrombocytopenia lasting more than 7 days; (6) Grade \\>=3 non-hematologic toxicity; (7) Failure to deliver at least 80% of the planned doses due to toxicities attributable to PF-04449913'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Treatment-emergent Adverse Events (AEs), by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.0) Grade', 'timeFrame': 'Baseline up to 28 days post last dose of study medication (maximum duration: 14 cycles [each cycle of 28 days])', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the worst CTCAE grade was reported. Grades as per NCI CTCAE, v4.0 were classified as: Grade 1- mild, Grade 2- moderate, Grade 3- severe, Grade 4- life threatening, and Grade 5- death.'}, {'measure': 'Percentage of Participants With Treatment-related AEs, by NCI CTCAE (Version 4.0) Grade', 'timeFrame': 'Baseline up to 28 days post last dose of study medication (maximum duration: 14 cycles [each cycle of 28 days])', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-related AEs are events that were assessed by the investigator as related to study medication. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the worst CTCAE grade was reported. Grades as per NCI CTCAE, v4.0 were classified as: Grade 1- mild, Grade 2- moderate, Grade 3- severe, Grade 4- life threatening, and Grade 5- death.'}, {'measure': 'Hedgehog Biomarker Modulation: Relative GLI1 Gene Expression (Ratio) to Baseline for Normal Skin on Cycle 1/Day 15', 'timeFrame': 'Baseline and Cycle 1/Day 15', 'description': 'Ribonucleic acid (RNA) was extracted from skin samples and complementary deoxyribonucleic acid (cDNA) was prepared. Gene expression was measured using custom Taqman low density array (TLDA) cards run on the Applied Biosystems ViiATM 7 system. The ratio for each participant at each dosing level was calculated at C1D15 to baseline assay readout (C1D1), and the mean of it is reported in this outcome measure.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) on Cycle 1/Day 1', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1', 'description': 'Cmax of PF-04449913 on Cycle 1/Day 1 has been reported.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) on Cycle 1/Day 25', 'timeFrame': 'Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25', 'description': 'Cmax of PF-04449913 on Cycle 1/Day 25 has been reported.'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) on Cycle 1/Day 1', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1', 'description': 'Tmax of PF-04449913 on Cycle 1/Day 1 has been reported.'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) on Cycle 1/Day 25', 'timeFrame': 'Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25', 'description': 'Tmax of PF-04449913 on Cycle 1/Day 25 has been reported.'}, {'measure': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Cycle 1/Day 1', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1', 'description': 'AUCtau of PF-04449913 on Cycle 1/Day 1 has been reported. AUCtau is defined as area under the curve from time 0 to tau, where tau is the dosing interval of 24 hours.'}, {'measure': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Cycle 1/Day 25', 'timeFrame': 'Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25', 'description': 'AUCtau of PF-04449913 on Cycle 1/Day 25 has been reported. AUCtau is defined as area under the curve from time 0 to tau, where tau is the dosing interval of 24 hours.'}, {'measure': 'Plasma Decay Half-life (t1/2) on Cycle 1/Day 25', 'timeFrame': 'Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Apparent Oral Clearance (CL/F) on Cycle 1/Day 25', 'timeFrame': 'Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.'}, {'measure': 'Apparent Volume of Distribution (Vz/F) on Cycle 1/Day 25', 'timeFrame': 'Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.'}, {'measure': 'Accumulation Ratio (Rac) on Cycle 1/Day 25', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1, and pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25', 'description': 'Accumulation ratio was calculated as AUCtau at steady state (Cycle 1/Day 25)/AUCtau on Study Day 1'}, {'measure': 'Average Concentration at Steady State (Cavg) on Cycle 1/Day 25', 'timeFrame': 'Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25'}, {'measure': "Number of Participants With Increase From Baseline in Corrected QT Using Fridericia's Formula (QTcF) Interval", 'timeFrame': 'Baseline up to Cycle 14 (each cycle 28 days)', 'description': "Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole (QT) was corrected for heart rate (QTc). QTc using Fridericia's formula (QTcF) was calculated. Participants with maximum increase from baseline of less than (\\<) 30 millisecond (msec), 30 to \\<60 msec and \\>=60 msec were summarized."}, {'measure': 'Number of Participants With Decrease From Baseline in QTcF Interval', 'timeFrame': 'Baseline up to Cycle 14 (each cycle 28 days)', 'description': 'Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QTcF was calculated. Participants with maximum decrease from baseline of \\<30 msec, 30 to \\<60 msec and \\>=60 msec were summarized.'}, {'measure': 'Number of Participants With Post-baseline QTcF Interval Greater Than or Equal to 500 Msec', 'timeFrame': 'Baseline up to Cycle 14 (each cycle 28 days)', 'description': 'Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. Participants with post-baseline absolute QTcF values \\>=500 msec were summarized.'}, {'measure': 'Percentage of Participants With Objective Response', 'timeFrame': 'Baseline up to Cycle 14 (each cycle 28 days)', 'description': 'Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as \\>=30% decrease under baseline of the sum of diameters of all target measurable lesions.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Baseline up to Cycle 14 (each cycle 28 days)', 'description': 'Time from Cycle 1/Day 1 to first documentation of disease progression or to death due to any cause, whichever occurred first. Progression was defined using RECIST 1.1 as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. PFS (days) was calculated as (first event date minus the date of first dose of study medication plus 1).'}, {'measure': 'Time to Progression (TTP)', 'timeFrame': 'Baseline up to Cycle 14 (each cycle 28 days)', 'description': 'Time from Cycle 1/Day 1 to first documentation of disease progression. Progression was defined using RECIST 1.1 as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. TTP (days) was calculated as (first event date minus the date of first dose of study medication plus 1).'}, {'measure': 'Duration of Response (DR)', 'timeFrame': 'Baseline up to Cycle 14 (each cycle 28 days)', 'description': 'Duration from date of first documentation of objective response to date of first documentation of disease progression or death. Progression was defined using RECIST 1.1 as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. DR was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first objective response that was subsequently confirmed plus 1).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PF-04449913', 'Hedgehog Inhibitor', 'Solid tumor', 'Pharmacokinetics', 'Safety', 'Pharmacodynamics'], 'conditions': ['Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '33993815', 'type': 'DERIVED', 'citation': 'Fostvedt LK, Shaik N, Martinelli G, Wagner AJ, Ruiz-Garcia A. Exposure-response modeling of the effect of glasdegib on cardiac repolarization in patients with cancer. Expert Rev Clin Pharmacol. 2021 Jul;14(7):927-935. doi: 10.1080/17512433.2021.1925538. Epub 2021 May 18.'}, {'pmid': '25388167', 'type': 'DERIVED', 'citation': 'Wagner AJ, Messersmith WA, Shaik MN, Li S, Zheng X, McLachlan KR, Cesari R, Courtney R, Levin WJ, El-Khoueiry AB. A phase I study of PF-04449913, an oral hedgehog inhibitor, in patients with advanced solid tumors. Clin Cancer Res. 2015 Mar 1;21(5):1044-51. doi: 10.1158/1078-0432.CCR-14-1116. Epub 2014 Nov 11.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371002&StudyName=A%20Study%20Of%20PF-04449913%20Administered%20Alone%20In%20Select%20Solid%20Tumors', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytological diagnosis of advanced/metastatic solid tumor\n* Adequate Bone Marrow Function\n* Adequate Renal Function\n* Adequate Liver Function\n\nExclusion Criteria:\n\n* Patients with known symptomatic brain metastases requiring steroids\n* Current active treatment on another clinical trial\n* Major surgery or radiation therapy within 4-weeks of starting study treatment'}, 'identificationModule': {'nctId': 'NCT01286467', 'briefTitle': 'A Study Of PF-04449913 Administered Alone In Select Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF PF 04449913, AN ORAL HEDGEHOG INHIBITOR, ADMINISTERED AS SINGLE AGENT IN SELECT SOLID TUMORS', 'orgStudyIdInfo': {'id': 'B1371002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: PF-04449913']}], 'interventions': [{'name': 'PF-04449913', 'type': 'DRUG', 'description': 'Escalating dose of PF-04449913 administered as tablets PO QD in 28-day cycles', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Keck Hospital of University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles County-University of Southern California Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California/Norris Comprehensive Cancer Center/Investigational Drug Service', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California/Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Anschutz Cancer Pavilion', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital (BWH)", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute (DFCI)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}