{"id":"https://openalex.org/W3030558241","doi":"https://doi.org/10.1002/cpdd.808","title":"Phase 1 Study to Evaluate the Effect of the Investigational Anticancer Agent Sapanisertib on the QTc Interval in Patients With Advanced Solid Tumors","display_name":"Phase 1 Study to Evaluate the Effect of the Investigational Anticancer Agent Sapanisertib on the QTc Interval in Patients With Advanced Solid Tumors","publication_year":2020,"publication_date":"2020-06-02","ids":{"openalex":"https://openalex.org/W3030558241","doi":"https://doi.org/10.1002/cpdd.808","mag":"3030558241","pmid":"https://pubmed.ncbi.nlm.nih.gov/32488989","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/7586797"},"language":"en","primary_location":{"id":"doi:10.1002/cpdd.808","doi":"https://doi.org/10.1002/cpdd.808","is_oa":true,"landing_page_url":"https://doi.org/10.1002/cpdd.808","pdf_url":"https://accp1.onlinelibrary.wiley.com/doi/pdfdirect/10.1002/cpdd.808","source":{"id":"https://openalex.org/S2764863641","display_name":"Clinical Pharmacology in Drug Development","issn_l":"2160-763X","issn":["2160-763X","2160-7648"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-b","jufo-1","ki-jl-1","medline","norway-1","poland-40","russia-white-list-2"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Pharmacology in Drug Development","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"hybrid","oa_url":"https://accp1.onlinelibrary.wiley.com/doi/pdfdirect/10.1002/cpdd.808","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5101449288","display_name":"Chirag Amrutlal Patel","orcid":"https://orcid.org/0000-0003-2969-2955","observed_orcids":["https://orcid.org/0000-0003-2969-2955"]},"institutions":[{"id":"https://openalex.org/I4405270001","display_name":"Takeda Oncology (United States)","ror":"https://ror.org/05vm7p871","country_code":"US","type":"company","lineage":["https://openalex.org/I4405270001"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Chirag Patel","raw_affiliation_strings":["Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA","institution_ids":["https://openalex.org/I4405270001"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5029455802","display_name":"Sanjay Goel","orcid":"https://orcid.org/0000-0002-2798-7568","observed_orcids":["https://orcid.org/0000-0002-2798-7568"]},"institutions":[{"id":"https://openalex.org/I1335289525","display_name":"Montefiore Medical Center","ror":"https://ror.org/044ntvm43","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1335289525","https://openalex.org/I19772626"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Sanjay Goel","raw_affiliation_strings":["Montefiore Medical Center, Bronx, New York, USA","Equal contribution"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Montefiore Medical Center, Bronx, New York, USA","institution_ids":["https://openalex.org/I1335289525"]},{"raw_affiliation_string":"Equal contribution","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5005718112","display_name":"Manish R. Patel","orcid":"https://orcid.org/0000-0001-6836-2364","observed_orcids":["https://orcid.org/0000-0001-6836-2364"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Manish R. Patel","raw_affiliation_strings":["Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, Florida, USA","Equal contribution"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, Florida, USA","institution_ids":[]},{"raw_affiliation_string":"Equal contribution","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5012805287","display_name":"Lakshmi Rangachari","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4405270001","display_name":"Takeda Oncology (United States)","ror":"https://ror.org/05vm7p871","country_code":"US","type":"company","lineage":["https://openalex.org/I4405270001"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Lakshmi Rangachari","raw_affiliation_strings":["Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA","institution_ids":["https://openalex.org/I4405270001"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5014598718","display_name":"Jayson D. Wilbur","orcid":"https://orcid.org/0009-0004-6761-6667","observed_orcids":["https://orcid.org/0009-0004-6761-6667"]},"institutions":[{"id":"https://openalex.org/I4210137375","display_name":"Metrum Research Group (United States)","ror":"https://ror.org/04j2hh758","country_code":"US","type":"company","lineage":["https://openalex.org/I4210137375"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Jayson D. Wilbur","raw_affiliation_strings":["Metrum Research Group, LCC, Connecticut, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Metrum Research Group, LCC, Connecticut, USA","institution_ids":["https://openalex.org/I4210137375"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5108499479","display_name":"Yaping Shou","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4405270001","display_name":"Takeda Oncology (United States)","ror":"https://ror.org/05vm7p871","country_code":"US","type":"company","lineage":["https://openalex.org/I4405270001"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Yaping Shou","raw_affiliation_strings":["Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA","institution_ids":["https://openalex.org/I4405270001"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5044490765","display_name":"Karthik Venkatakrishnan","orcid":"https://orcid.org/0000-0003-4039-9813","observed_orcids":["https://orcid.org/0000-0003-4039-9813"]},"institutions":[{"id":"https://openalex.org/I4405270001","display_name":"Takeda Oncology (United States)","ror":"https://ror.org/05vm7p871","country_code":"US","type":"company","lineage":["https://openalex.org/I4405270001"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Karthik Venkatakrishnan","raw_affiliation_strings":["Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA","institution_ids":["https://openalex.org/I4405270001"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5103111166","display_name":"Albert Craig Lockhart","orcid":"https://orcid.org/0000-0002-0132-5523","observed_orcids":["https://orcid.org/0000-0002-0132-5523"]},"institutions":[{"id":"https://openalex.org/I145608581","display_name":"University of Miami","ror":"https://ror.org/02dgjyy92","country_code":"US","type":"education","lineage":["https://openalex.org/I145608581"]},{"id":"https://openalex.org/I4210157065","display_name":"Sylvester Comprehensive Cancer Center","ror":"https://ror.org/0552r4b12","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I145608581","https://openalex.org/I4210101935","https://openalex.org/I4210157065"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"A. Craig Lockhart","raw_affiliation_strings":["Sylvester Comprehensive Cancer Center, Miller School of Medicine, University of Miami, Miami, Florida, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Sylvester Comprehensive Cancer Center, Miller School of Medicine, University of Miami, Miami, Florida, USA","institution_ids":["https://openalex.org/I145608581","https://openalex.org/I4210157065"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":5,"corresponding_author_ids":["https://openalex.org/A5101449288"],"corresponding_institution_ids":["https://openalex.org/I4405270001"],"apc_list":{"value":3300,"currency":"USD","value_usd":3300},"apc_paid":{"value":3300,"currency":"USD","value_usd":3300},"fwci":1.0835,"has_fulltext":true,"cited_by_count":13,"citation_normalized_percentile":{"value":0.79522388,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":93,"max":98},"biblio":{"volume":"9","issue":"7","first_page":"876","last_page":"888"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10217","display_name":"Cardiac electrophysiology and arrhythmias","score":0.8105000257492065,"subfield":{"id":"https://openalex.org/subfields/2705","display_name":"Cardiology and Cardiovascular Medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10217","display_name":"Cardiac electrophysiology and arrhythmias","score":0.8105000257492065,"subfield":{"id":"https://openalex.org/subfields/2705","display_name":"Cardiology and Cardiovascular Medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11535","display_name":"Chemotherapy-induced cardiotoxicity and mitigation","score":0.11819999665021896,"subfield":{"id":"https://openalex.org/subfields/2705","display_name":"Cardiology and Cardiovascular Medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10417","display_name":"Lung Cancer Treatments and Mutations","score":0.006000000052154064,"subfield":{"id":"https://openalex.org/subfields/2740","display_name":"Pulmonary and Respiratory Medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/sapanisertib","display_name":"sapanisertib","score":1.0},{"id":"https://openalex.org/keywords/qtc-interval","display_name":"QTc interval","score":0.828000009059906},{"id":"https://openalex.org/keywords/qt-interval-prolongation","display_name":"QT prolongation","score":0.7229999899864197},{"id":"https://openalex.org/keywords/advanced-solid-tumors","display_name":"advanced solid tumors","score":0.9039999842643738},{"id":"https://openalex.org/keywords/anticancer-agents","display_name":"anticancer agents","score":0.7519999742507935},{"id":"https://openalex.org/keywords/pharmacokinetics","display_name":"pharmacokinetics","score":0.949999988079071},{"id":"https://openalex.org/keywords/drug-safety","display_name":"drug safety","score":0.5149999856948853},{"id":"https://openalex.org/keywords/tolerability","display_name":"tolerability","score":0.6790000200271606},{"id":"https://openalex.org/keywords/adverse-events","display_name":"adverse events","score":0.46399998664855957},{"id":"https://openalex.org/keywords/single-dose-pharmacokinetics","display_name":"single-dose pharmacokinetics","score":0.5540000200271606},{"id":"https://openalex.org/keywords/once-weekly-dosing","display_name":"weekly dosing","score":0.5460000038146973}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.88701331615448},{"id":"https://openalex.org/C118441451","wikidata":"https://www.wikidata.org/wiki/Q12074763","display_name":"QT interval","level":2,"score":0.8169682025909424},{"id":"https://openalex.org/C2777288759","wikidata":"https://www.wikidata.org/wiki/Q4164182","display_name":"Dosing","level":2,"score":0.7067279815673828},{"id":"https://openalex.org/C2778375690","wikidata":"https://www.wikidata.org/wiki/Q7814214","display_name":"Tolerability","level":3,"score":0.6481032371520996},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.6297510266304016},{"id":"https://openalex.org/C2780580376","wikidata":"https://www.wikidata.org/wiki/Q186889","display_name":"Nausea","level":2,"score":0.6277415156364441},{"id":"https://openalex.org/C112705442","wikidata":"https://www.wikidata.org/wiki/Q323936","display_name":"Pharmacokinetics","level":2,"score":0.5792151689529419},{"id":"https://openalex.org/C42219234","wikidata":"https://www.wikidata.org/wiki/Q131130","display_name":"Anesthesia","level":1,"score":0.4997062683105469},{"id":"https://openalex.org/C2780852908","wikidata":"https://www.wikidata.org/wiki/Q127076","display_name":"Vomiting","level":2,"score":0.4993159770965576},{"id":"https://openalex.org/C44249647","wikidata":"https://www.wikidata.org/wiki/Q208498","display_name":"Confidence interval","level":2,"score":0.48889675736427307},{"id":"https://openalex.org/C2777953023","wikidata":"https://www.wikidata.org/wiki/Q1073121","display_name":"Heart rate","level":3,"score":0.48254746198654175},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.36998438835144043},{"id":"https://openalex.org/C126894567","wikidata":"https://www.wikidata.org/wiki/Q105650","display_name":"Urology","level":1,"score":0.32068461179733276},{"id":"https://openalex.org/C84393581","wikidata":"https://www.wikidata.org/wiki/Q82642","display_name":"Blood pressure","level":2,"score":0.2540375292301178}],"mesh":[{"descriptor_ui":"D000225","descriptor_name":"Adenine","qualifier_ui":"Q000031","qualifier_name":"analogs & derivatives","is_major_topic":false},{"descriptor_ui":"D000284","descriptor_name":"Administration, Oral","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D000328","descriptor_name":"Adult","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D000368","descriptor_name":"Aged","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D000970","descriptor_name":"Antineoplastic Agents","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":false},{"descriptor_ui":"D000970","descriptor_name":"Antineoplastic Agents","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D000970","descriptor_name":"Antineoplastic Agents","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":true},{"descriptor_ui":"D000970","descriptor_name":"Antineoplastic Agents","qualifier_ui":"Q000494","qualifier_name":"pharmacology","is_major_topic":false},{"descriptor_ui":"D001583","descriptor_name":"Benzoxazoles","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004305","descriptor_name":"Dose-Response Relationship, Drug","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004562","descriptor_name":"Electrocardiography","qualifier_ui":"Q000187","qualifier_name":"drug effects","is_major_topic":false},{"descriptor_ui":"D004562","descriptor_name":"Electrocardiography","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D005260","descriptor_name":"Female","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006339","descriptor_name":"Heart Rate","qualifier_ui":"Q000187","qualifier_name":"drug effects","is_major_topic":true},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D008133","descriptor_name":"Long QT Syndrome","qualifier_ui":"Q000139","qualifier_name":"chemically induced","is_major_topic":false},{"descriptor_ui":"D008133","descriptor_name":"Long QT Syndrome","qualifier_ui":"Q000453","qualifier_name":"epidemiology","is_major_topic":false},{"descriptor_ui":"D008133","descriptor_name":"Long QT Syndrome","qualifier_ui":"Q000503","qualifier_name":"physiopathology","is_major_topic":false},{"descriptor_ui":"D008297","descriptor_name":"Male","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D008875","descriptor_name":"Middle Aged","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D009369","descriptor_name":"Neoplasms","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":true},{"descriptor_ui":"D009369","descriptor_name":"Neoplasms","qualifier_ui":"Q000473","qualifier_name":"pathology","is_major_topic":false},{"descriptor_ui":"D011720","descriptor_name":"Pyrazoles","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":false},{"descriptor_ui":"D011720","descriptor_name":"Pyrazoles","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D011720","descriptor_name":"Pyrazoles","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":true},{"descriptor_ui":"D011720","descriptor_name":"Pyrazoles","qualifier_ui":"Q000494","qualifier_name":"pharmacology","is_major_topic":false},{"descriptor_ui":"D011743","descriptor_name":"Pyrimidines","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":false},{"descriptor_ui":"D011743","descriptor_name":"Pyrimidines","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D011743","descriptor_name":"Pyrimidines","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":true},{"descriptor_ui":"D011743","descriptor_name":"Pyrimidines","qualifier_ui":"Q000494","qualifier_name":"pharmacology","is_major_topic":false},{"descriptor_ui":"D012449","descriptor_name":"Safety","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D058570","descriptor_name":"TOR Serine-Threonine Kinases","qualifier_ui":"Q000037","qualifier_name":"antagonists & inhibitors","is_major_topic":true}],"locations_count":4,"locations":[{"id":"doi:10.1002/cpdd.808","doi":"https://doi.org/10.1002/cpdd.808","is_oa":true,"landing_page_url":"https://doi.org/10.1002/cpdd.808","pdf_url":"https://accp1.onlinelibrary.wiley.com/doi/pdfdirect/10.1002/cpdd.808","source":{"id":"https://openalex.org/S2764863641","display_name":"Clinical Pharmacology in Drug Development","issn_l":"2160-763X","issn":["2160-763X","2160-7648"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-b","jufo-1","ki-jl-1","medline","norway-1","poland-40","russia-white-list-2"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Pharmacology in Drug Development","raw_type":"journal-article"},{"id":"pmh:oai:europepmc.org:6536436","doi":null,"is_oa":true,"landing_page_url":"http://europepmc.org/pmc/articles/PMC7586797","pdf_url":null,"source":{"id":"https://openalex.org/S4306400806","display_name":"Europe PMC (PubMed Central)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1303153112","host_organization_name":"European Bioinformatics Institute","host_organization_lineage":["https://openalex.org/I1303153112"],"host_organization_lineage_names":[],"type":"repository"},"license":"other-oa","license_id":"https://openalex.org/licenses/other-oa","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"","raw_type":"Text"},{"id":"pmh:oai:pubmedcentral.nih.gov:7586797","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/7586797","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clin Pharmacol Drug Dev","raw_type":"Text"},{"id":"pmid:32488989","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/32488989","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical pharmacology in drug development","raw_type":"Clinical Trial, Phase I"}],"best_oa_location":{"id":"doi:10.1002/cpdd.808","doi":"https://doi.org/10.1002/cpdd.808","is_oa":true,"landing_page_url":"https://doi.org/10.1002/cpdd.808","pdf_url":"https://accp1.onlinelibrary.wiley.com/doi/pdfdirect/10.1002/cpdd.808","source":{"id":"https://openalex.org/S2764863641","display_name":"Clinical Pharmacology in Drug Development","issn_l":"2160-763X","issn":["2160-763X","2160-7648"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-b","jufo-1","ki-jl-1","medline","norway-1","poland-40","russia-white-list-2"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Pharmacology in Drug Development","raw_type":"journal-article"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","score":1.0,"display_name":"Good health and well-being"}],"study_designs":[{"id":"https://openalex.org/study-designs/clinical-trial","display_name":"Clinical Trial"}],"awards":[],"funders":[{"id":"https://openalex.org/F4320333265","display_name":"Takeda Oncology","ror":"https://ror.org/05vm7p871"}],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W3030558241.pdf","grobid_xml":"https://content.openalex.org/works/W3030558241.grobid-xml"},"referenced_works_count":25,"referenced_works":["https://openalex.org/W1850718232","https://openalex.org/W1909306694","https://openalex.org/W1978647133","https://openalex.org/W1980396381","https://openalex.org/W1988368217","https://openalex.org/W2009937603","https://openalex.org/W2010293399","https://openalex.org/W2047259010","https://openalex.org/W2080238287","https://openalex.org/W2083133947","https://openalex.org/W2096104621","https://openalex.org/W2115686439","https://openalex.org/W2128143798","https://openalex.org/W2138129102","https://openalex.org/W2145137957","https://openalex.org/W2153867442","https://openalex.org/W2168298851","https://openalex.org/W2286842342","https://openalex.org/W2463344929","https://openalex.org/W2491467159","https://openalex.org/W2586196562","https://openalex.org/W2621778374","https://openalex.org/W2771291368","https://openalex.org/W2778446942","https://openalex.org/W2785624388"],"related_works":["https://openalex.org/W1983768757","https://openalex.org/W2080215255","https://openalex.org/W4382181944","https://openalex.org/W1963485775","https://openalex.org/W2745654494","https://openalex.org/W2516022576","https://openalex.org/W2002178750","https://openalex.org/W2604307041","https://openalex.org/W2953039586","https://openalex.org/W2113098758"],"abstract_inverted_index":{"The":[0,81,182,225],"aim":[1],"of":[2,12,89,93,126,228],"this":[3],"phase":[4],"1":[5,159],"study":[6],"was":[7,84,163,234],"to":[8,35,58,66,78,85,104],"determine":[9],"the":[10,15,87,98,119,170],"effects":[11,215],"sapanisertib":[13,39,68,94,113,165,188,206,229],"on":[14,97,216],"heart":[16],"rate-corrected":[17,142,176],"QT":[18,99,143],"(QTc)":[19],"interval":[20,144,178,218],"in":[21,73,116,169,219],"patients":[22,28,220],"with":[23,29,221],"advanced":[24,30,222],"solid":[25,31,223],"tumors.":[26,224],"Adult":[27],"tumors":[32],"were":[33,47,52,103,135,193,241],"enrolled":[34],"receive":[36,67],"a":[37,90,111],"single":[38,91,112,205],"40-mg":[40,114],"dose.":[41],"Blood":[42],"samples":[43],"for":[44,76,140,155],"pharmacokinetic":[45],"analysis":[46],"collected":[48],"and":[49,56,108,150,200,236],"electrocardiogram":[50],"readings":[51],"recorded":[53],"at":[54,145,158],"baseline":[55,134,174],"up":[57,77],"48":[59],"hours":[60,147],"after":[61,148],"dosing.":[62],"Patients":[63],"could":[64],"continue":[65],"30":[69,189,230],"mg":[70,190,208,231],"once":[71,232],"weekly":[72,233],"28-day":[74],"cycles":[75],"12":[79],"months.":[80],"primary":[82],"objective":[83],"characterize":[86],"effect":[88],"dose":[92,115,209],"(40":[95],"mg)":[96],"interval.":[100],"Secondary":[101],"objectives":[102],"evaluate":[105],"safety,":[106],"tolerability,":[107],"pharmacokinetics.":[109],"Following":[110],"44":[117],"patients,":[118],"maximum":[120],"least":[121],"squares":[122],"mean":[123],"(upper":[124],"bound":[125],"1-sided":[127],"95%":[128],"confidence":[129],"interval)":[130],"changes":[131],"from":[132,172],"time-matched":[133,173],"7.1":[136],"milliseconds":[137,152],"(11.4":[138],"milliseconds)":[139,154],"individual":[141,175],"24":[146],"dosing,":[149],"1.8":[151],"(5.6":[153],"Fridericia-corrected":[156,180],"QTc":[157,177,217],"hour":[160],"post-dose.":[161],"There":[162],"no":[164,237],"plasma":[166],"concentration-dependent":[167],"increase":[168],"change":[171],"or":[179],"QTc.":[181],"most":[183],"common":[184],"adverse":[185],"events":[186],"following":[187],"once-weekly":[191],"dosing":[192],"nausea":[194],"(80%),":[195],"fatigue":[196],"(61%),":[197],"vomiting":[198],"(57%),":[199],"decreased":[201],"appetite":[202],"(45%).":[203],"A":[204],"40":[207],"did":[210],"not":[211],"produce":[212],"clinically":[213],"relevant":[214],"safety":[226,239],"profile":[227],"favorable,":[235],"new":[238],"signals":[240],"observed":[242],"(NCT02197572,":[243],"clinicaltrials.gov).":[244]},"counts_by_year":[{"year":2026,"cited_by_count":1},{"year":2025,"cited_by_count":5},{"year":2023,"cited_by_count":3},{"year":2022,"cited_by_count":2},{"year":2021,"cited_by_count":2}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2020-06-05T00:00:00"}