{"id":"https://openalex.org/W4206380271","doi":"https://doi.org/10.1200/jco.2022.40.4_suppl.tps516","title":"Randomized, parallel arm, phase II study of telotristat (Xermelo) in combination with lutetium Lu 177 dotatate (Lutathera) in well-differentiated neuroendocrine tumors (NETs).","display_name":"Randomized, parallel arm, phase II study of telotristat (Xermelo) in combination with lutetium Lu 177 dotatate (Lutathera) in well-differentiated neuroendocrine tumors (NETs).","publication_year":2022,"publication_date":"2022-01-19","ids":{"openalex":"https://openalex.org/W4206380271","doi":"https://doi.org/10.1200/jco.2022.40.4_suppl.tps516"},"language":"en","primary_location":{"id":"doi:10.1200/jco.2022.40.4_suppl.tps516","doi":"https://doi.org/10.1200/jco.2022.40.4_suppl.tps516","is_oa":false,"landing_page_url":"https://doi.org/10.1200/jco.2022.40.4_suppl.tps516","pdf_url":null,"source":{"id":"https://openalex.org/S15137598","display_name":"Journal of Clinical Oncology","issn_l":"0732-183X","issn":["0732-183X","1527-7755"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Clinical Oncology","raw_type":"journal-article"},"volume":null,"type":"conference-abstract","indexed_in":["crossref"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5051388864","display_name":"Aman Chauhan","orcid":"https://orcid.org/0009-0003-0136-1983","observed_orcids":["https://orcid.org/0009-0003-0136-1983","https://orcid.org/0000-0002-4183-2116"]},"institutions":[{"id":"https://openalex.org/I143302722","display_name":"University of Kentucky","ror":"https://ror.org/02k3smh20","country_code":"US","type":"education","lineage":["https://openalex.org/I143302722"]},{"id":"https://openalex.org/I2802239656","display_name":"Markey Cancer Center","ror":"https://ror.org/01dhvva97","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1285210727","https://openalex.org/I143302722","https://openalex.org/I2802239656"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Aman Chauhan","raw_affiliation_strings":["UK Markey Cancer Center, University of Kentucky, Lexington, KY;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"UK Markey Cancer Center, University of Kentucky, Lexington, KY;","institution_ids":["https://openalex.org/I143302722","https://openalex.org/I2802239656"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5042269391","display_name":"Charles A. Kunos","orcid":"https://orcid.org/0009-0004-4056-9004","observed_orcids":["https://orcid.org/0009-0004-4056-9004"]},"institutions":[{"id":"https://openalex.org/I143302722","display_name":"University of Kentucky","ror":"https://ror.org/02k3smh20","country_code":"US","type":"education","lineage":["https://openalex.org/I143302722"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Charles Kunos","raw_affiliation_strings":["University of Kentucky, Radiation Oncology, Lexington, KY;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Kentucky, Radiation Oncology, Lexington, KY;","institution_ids":["https://openalex.org/I143302722"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5008470507","display_name":"Donglin Yan","orcid":"https://orcid.org/0000-0002-5111-9437","observed_orcids":["https://orcid.org/0000-0002-5111-9437"]},"institutions":[{"id":"https://openalex.org/I143302722","display_name":"University of Kentucky","ror":"https://ror.org/02k3smh20","country_code":"US","type":"education","lineage":["https://openalex.org/I143302722"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Donglin Yan","raw_affiliation_strings":["University of Kentucky, Lexington, KY;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Kentucky, Lexington, KY;","institution_ids":["https://openalex.org/I143302722"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5081228618","display_name":"Aman Khurana","orcid":"https://orcid.org/0000-0002-1529-0624","observed_orcids":["https://orcid.org/0000-0002-1529-0624"]},"institutions":[{"id":"https://openalex.org/I143302722","display_name":"University of Kentucky","ror":"https://ror.org/02k3smh20","country_code":"US","type":"education","lineage":["https://openalex.org/I143302722"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Aman Khurana","raw_affiliation_strings":["University of Kentucky, Department of Radiology, Lexington, KY;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Kentucky, Department of Radiology, Lexington, KY;","institution_ids":["https://openalex.org/I143302722"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5050035571","display_name":"Riham H. El Khouli","orcid":"https://orcid.org/0000-0002-1892-491X","observed_orcids":["https://orcid.org/0000-0002-1892-491X"]},"institutions":[{"id":"https://openalex.org/I143302722","display_name":"University of Kentucky","ror":"https://ror.org/02k3smh20","country_code":"US","type":"education","lineage":["https://openalex.org/I143302722"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Riham Khouli","raw_affiliation_strings":["University of Kentucky, Lexington, KY;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Kentucky, Lexington, KY;","institution_ids":["https://openalex.org/I143302722"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5000979293","display_name":"Michael J. Cavnar","orcid":"https://orcid.org/0000-0002-6197-7945","observed_orcids":["https://orcid.org/0000-0002-6197-7945"]},"institutions":[{"id":"https://openalex.org/I143302722","display_name":"University of Kentucky","ror":"https://ror.org/02k3smh20","country_code":"US","type":"education","lineage":["https://openalex.org/I143302722"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Michael J. Cavnar","raw_affiliation_strings":["University of Kentucky, Lexington, KY;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Kentucky, Lexington, KY;","institution_ids":["https://openalex.org/I143302722"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5011353754","display_name":"Prakash Krishnan Pandalai","orcid":"https://orcid.org/0000-0002-2729-0058","observed_orcids":["https://orcid.org/0000-0002-2729-0058"]},"institutions":[{"id":"https://openalex.org/I143302722","display_name":"University of Kentucky","ror":"https://ror.org/02k3smh20","country_code":"US","type":"education","lineage":["https://openalex.org/I143302722"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Prakash Pandalai","raw_affiliation_strings":["University of Kentucky, Surgical Oncology, Lexington, KY;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Kentucky, Surgical Oncology, Lexington, KY;","institution_ids":["https://openalex.org/I143302722"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5100650735","display_name":"Joseph Kim","orcid":"https://orcid.org/0000-0001-6313-1516","observed_orcids":["https://orcid.org/0000-0001-6313-1516"]},"institutions":[{"id":"https://openalex.org/I59553526","display_name":"Stony Brook University","ror":"https://ror.org/05qghxh33","country_code":"US","type":"education","lineage":["https://openalex.org/I59553526"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Joseph Kim","raw_affiliation_strings":["SUNY Stony Brook, Stony Brook, NY;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"SUNY Stony Brook, Stony Brook, NY;","institution_ids":["https://openalex.org/I59553526"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5005448318","display_name":"Lowell Brian Anthony","orcid":"https://orcid.org/0000-0001-7348-7874","observed_orcids":["https://orcid.org/0000-0001-7348-7874"]},"institutions":[{"id":"https://openalex.org/I143302722","display_name":"University of Kentucky","ror":"https://ror.org/02k3smh20","country_code":"US","type":"education","lineage":["https://openalex.org/I143302722"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Lowell Brian Anthony","raw_affiliation_strings":["University of Kentucky, Lexington, KY;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Kentucky, Lexington, KY;","institution_ids":["https://openalex.org/I143302722"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":3,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":null,"has_fulltext":false,"cited_by_count":1,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":"40","issue":"4_suppl","first_page":"TPS516","last_page":"TPS516"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10754","display_name":"Neuroendocrine Tumor Research Advances","score":0.9994999766349792,"subfield":{"id":"https://openalex.org/subfields/2713","display_name":"Epidemiology"},"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/T10754","display_name":"Neuroendocrine Tumor Research Advances","score":0.9994999766349792,"subfield":{"id":"https://openalex.org/subfields/2713","display_name":"Epidemiology"},"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/T10832","display_name":"Pituitary Gland Disorders and Treatments","score":0.0,"subfield":{"id":"https://openalex.org/subfields/2712","display_name":"Endocrinology, Diabetes and Metabolism"},"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/T11067","display_name":"Colorectal Cancer Treatments and Studies","score":0.0,"subfield":{"id":"https://openalex.org/subfields/2730","display_name":"Oncology"},"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/telotristat-ethyl","display_name":"telotristat ethyl","score":0.9419999718666077},{"id":"https://openalex.org/keywords/well-differentiated-neuroendocrine-tumors","display_name":"well-differentiated neuroendocrine tumors","score":0.8679999709129333},{"id":"https://openalex.org/keywords/peptide-receptor-radionuclide-therapy","display_name":"peptide receptor radionuclide therapy","score":0.8550000190734863},{"id":"https://openalex.org/keywords/tryptophan-hydroxylase-inhibition","display_name":"tryptophan hydroxylase inhibition","score":0.9440000057220459},{"id":"https://openalex.org/keywords/serotonin-synthesis","display_name":"serotonin synthesis","score":0.7879999876022339},{"id":"https://openalex.org/keywords/combination-therapy","display_name":"combination therapy","score":0.8009999990463257},{"id":"https://openalex.org/keywords/progression-free-survival","display_name":"progression-free survival","score":0.9240000247955322},{"id":"https://openalex.org/keywords/carcinoid-syndrome","display_name":"carcinoid syndrome","score":0.5649999976158142},{"id":"https://openalex.org/keywords/dose-escalation","display_name":"dose escalation","score":0.3240000009536743},{"id":"https://openalex.org/keywords/urinary-5-hiaa","display_name":"urinary 5-HIAA","score":0.6439999938011169}],"concepts":[{"id":"https://openalex.org/C2779066768","wikidata":"https://www.wikidata.org/wiki/Q1981276","display_name":"Neuroendocrine tumors","level":2,"score":0.8448860049247742},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.7430896759033203},{"id":"https://openalex.org/C2781151469","wikidata":"https://www.wikidata.org/wiki/Q339547","display_name":"Carcinoid syndrome","level":2,"score":0.6606397032737732},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.5442410707473755},{"id":"https://openalex.org/C2775951788","wikidata":"https://www.wikidata.org/wiki/Q418293","display_name":"Tryptophan hydroxylase","level":5,"score":0.5137490034103394},{"id":"https://openalex.org/C2776297358","wikidata":"https://www.wikidata.org/wiki/Q407166","display_name":"Somatostatin","level":2,"score":0.5014340877532959},{"id":"https://openalex.org/C203092338","wikidata":"https://www.wikidata.org/wiki/Q1340863","display_name":"Clinical endpoint","level":3,"score":0.4745103716850281},{"id":"https://openalex.org/C2775864247","wikidata":"https://www.wikidata.org/wiki/Q167934","display_name":"Serotonin","level":3,"score":0.4687635600566864},{"id":"https://openalex.org/C90924648","wikidata":"https://www.wikidata.org/wiki/Q120569","display_name":"Gastroenterology","level":1,"score":0.43987470865249634},{"id":"https://openalex.org/C520551903","wikidata":"https://www.wikidata.org/wiki/Q1857","display_name":"Lutetium","level":4,"score":0.412462443113327},{"id":"https://openalex.org/C134018914","wikidata":"https://www.wikidata.org/wiki/Q162606","display_name":"Endocrinology","level":1,"score":0.3937391936779022},{"id":"https://openalex.org/C143998085","wikidata":"https://www.wikidata.org/wiki/Q162555","display_name":"Oncology","level":1,"score":0.35882335901260376},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.23127394914627075},{"id":"https://openalex.org/C185592680","wikidata":"https://www.wikidata.org/wiki/Q2329","display_name":"Chemistry","level":0,"score":0.09163850545883179},{"id":"https://openalex.org/C170493617","wikidata":"https://www.wikidata.org/wiki/Q208467","display_name":"Receptor","level":2,"score":0.08966726064682007},{"id":"https://openalex.org/C37000724","wikidata":"https://www.wikidata.org/wiki/Q50430226","display_name":"Serotonergic","level":4,"score":0.0},{"id":"https://openalex.org/C2779851234","wikidata":"https://www.wikidata.org/wiki/Q50690","display_name":"Oxide","level":2,"score":0.0},{"id":"https://openalex.org/C178790620","wikidata":"https://www.wikidata.org/wiki/Q11351","display_name":"Organic chemistry","level":1,"score":0.0},{"id":"https://openalex.org/C531131001","wikidata":"https://www.wikidata.org/wiki/Q941","display_name":"Yttrium","level":3,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1200/jco.2022.40.4_suppl.tps516","doi":"https://doi.org/10.1200/jco.2022.40.4_suppl.tps516","is_oa":false,"landing_page_url":"https://doi.org/10.1200/jco.2022.40.4_suppl.tps516","pdf_url":null,"source":{"id":"https://openalex.org/S15137598","display_name":"Journal of Clinical Oncology","issn_l":"0732-183X","issn":["0732-183X","1527-7755"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Clinical Oncology","raw_type":"journal-article"}],"best_oa_location":null,"sustainable_development_goals":[{"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3","score":0.9922999739646912}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W4281861290","https://openalex.org/W7162253870","https://openalex.org/W4200111473","https://openalex.org/W2337997014","https://openalex.org/W2962710714","https://openalex.org/W4400272753","https://openalex.org/W2765426669","https://openalex.org/W3200433105","https://openalex.org/W7152051784","https://openalex.org/W7171500043"],"abstract_inverted_index":{"TPS516":[0],"Background:":[1],"PRRT":[2,36],"using":[3],"Lutetium":[4,283],"Lu":[5,284],"177":[6,229,285],"Dotatate,":[7],"has":[8],"been":[9],"approved":[10,172],"by":[11,87,135,244],"the":[12,50,107,168],"FDA":[13,171],"for":[14,180],"metastatic,":[15],"progressive":[16],"gastroenteropancreatic":[17],"neuroendocrine":[18,52,220,291],"tumors":[19,221],"(GEPNETs).":[20],"Despite":[21],"an":[22,64,93],"impressive":[23],"progression-free":[24],"survival":[25],"noted":[26],"in":[27,43,57,92,110,150,153,195,238,280,288,305],"NETTER-1":[28],"study,":[29],"most":[30],"patients":[31,128,298],"will":[32,214,223,236],"eventually":[33],"progress":[34],"after":[35],"treatment.":[37],"Increased":[38],"serotonin":[39,88,111,212],"secretion":[40],"is":[41,98,256,295,300],"found":[42],"a":[44,61,69,75,99,257],"number":[45],"of":[46,49,60,85,103,116,167,178,182,211,227,272],"slow-growing":[47],"NETs":[48],"diffuse":[51],"system.":[53],"Serotonin":[54],"stimulates":[55],"proliferation":[56],"cell":[58,80],"lines":[59],"typical":[62],"(NCI-H727),":[63],"atypical":[65],"(NCI-H720)":[66],"bronchopulmonary":[67],"NET,":[68],"small":[70],"intestinal":[71],"NET":[72],"(KRJ-I),":[73],"and":[74,145,148,157,222,299],"functioning":[76],"human":[77],"pancreatic":[78],"carcinoid":[79,130,183],"line":[81],"(BON).":[82],"This":[83,255],"stimulation":[84],"growth":[86],"can":[89],"be":[90],"performed":[91],"autocrine":[94],"manner.":[95],"Telotristat":[96,123,140,179,273],"ethyl":[97,124,141],"novel":[100],"oral":[101],"inhibitor":[102],"tryptophan":[104],"hydroxylase":[105],"(TPH),":[106],"rate-limiting":[108],"enzyme":[109],"biosynthesis.":[112],"In":[113],"2017,":[114],"results":[115,166],"placebo-controlled":[117],"phase":[118,265],"III":[119],"study":[120,267],"(Telestar)":[121],"evaluating":[122,268],"confirmed":[125],"that":[126,209],"among":[127],"with":[129,139,282],"syndrome":[131,184],"not":[132],"adequately":[133],"controlled":[134],"somatostatin":[136],"analogs,":[137],"treatment":[138,240],"was":[142],"generally":[143],"safe":[144],"well":[146],"tolerated":[147],"resulted":[149],"significant":[151],"reductions":[152],"bowel":[154],"movement":[155],"frequency":[156],"urinary":[158,196],"5-":[159],"hydroxy":[160],"indoleacetic":[161],"acid":[162],"(u5-HIAA).":[163],"Based":[164],"on":[165,219],"Telestar":[169],"trial,":[170],"250":[173,201,275],"mg":[174,189,202,276],"PO":[175],"TID":[176,190,203],"dosage":[177],"control":[181,252],"diarrhea.":[185],"Of":[186],"note,":[187],"500":[188,278],"arm":[191],"showed":[192],"increased":[193],"decline":[194],"5-HIAA":[197],"as":[198,242,248],"compared":[199,249],"to":[200,216,250,302],"arm.":[204],"Study":[205,294],"Hypotheses:":[206],"We":[207,231],"hypothesize":[208],"inhibition":[210],"production":[213],"lead":[215],"cytostatic":[217],"effect":[218],"complement":[224],"anti-tumor":[225],"activity":[226],"lutetium":[228],"dotatate.":[230],"anticipate":[232],"our":[233],"proposed":[234],"combination":[235,281],"result":[237],"improved":[239,245],"efficacy":[241],"reflected":[243],"20-month":[246],"PFS":[247],"historical":[251],"(NETTER-1).":[253],"Methods:":[254],"single":[258],"center,":[259],"open":[260],"label,":[261],"randomized,":[262],"parallel":[263],"arm,":[264],"II":[266],"two":[269],"dose":[270],"levels":[271],"(Xermelo;":[274],"vs":[277],"mg)":[279],"Dotatate":[286],"(Lutathera)":[287],"70":[289],"well-differentiated":[290],"tumor":[292],"patients.":[293],"currently":[296],"enrolling":[297],"expected":[301],"complete":[303],"accrual":[304],"3":[306],"years.":[307],"Clinical":[308],"trial":[309],"information:":[310],"NCT04543955.":[311]},"counts_by_year":[{"year":2024,"cited_by_count":1}],"updated_date":"2026-10-17T09:40:24.721904","created_date":"2022-01-26T00:00:00"}