Phase 1 dose-escalation study of IV ixazomib, an investigational proteasome inhibitor, in patients with relapsed/refractory lymphoma
Ixazomib is an investigational proteasome inhibitor that has shown preclinical activity in lymphoma models. This phase 1 study assessed the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics, pharmacodynamics and preliminary activity of intravenous (IV) ixazomib in relapsed/refract...
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| Veröffentlicht in: | Blood cancer journal (New York) 2014-10, Vol.4 (10), p.e251-e251 |
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| creator | Assouline, S E Chang, J Cheson, B D Rifkin, R Hamburg, S Reyes, R Hui, A-M Yu, J Gupta, N Di Bacco, A Shou, Y Martin, P |
| description | Ixazomib is an investigational proteasome inhibitor that has shown preclinical activity in lymphoma models. This phase 1 study assessed the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics, pharmacodynamics and preliminary activity of intravenous (IV) ixazomib in relapsed/refractory lymphoma patients who had received ⩾2 prior therapies. Thirty patients with a range of histologies received ixazomib 0.125−3.11 mg/m
2
on days 1, 8 and 15 of 28-day cycles. Patients received a median of two cycles (range 1−36). MTD was determined to be 2.34 mg/m
2
. Most common drug-related adverse events (AEs) included fatigue (43%), diarrhea (33%), nausea, vomiting and thrombocytopenia (each 27%). Drug-related grade ⩾3 AEs included neutropenia (20%), thrombocytopenia (13%) and diarrhea (10%). Drug-related peripheral neuropathy occurred in four (13%) patients; no grade ⩾3 events were reported. Plasma exposure increased dose proportionally from 0.5−3.11 mg/m
2
; terminal half-life was 4−12 days after multiple dosing. Of 26 evaluable patients, five achieved responses: 4/11 follicular lymphoma patients (one complete and three partial responses) and 1/4 peripheral T-cell lymphoma patients (partial response). Sustained responses were observed with ⩾32 cycles of treatment in two heavily pretreated follicular lymphoma patients. Results suggest weekly IV ixazomib is generally well tolerated and may be clinically active in relapsed/refractory lymphoma. |
| doi_str_mv | 10.1038/bcj.2014.71 |
| format | Article |
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2
on days 1, 8 and 15 of 28-day cycles. Patients received a median of two cycles (range 1−36). MTD was determined to be 2.34 mg/m
2
. Most common drug-related adverse events (AEs) included fatigue (43%), diarrhea (33%), nausea, vomiting and thrombocytopenia (each 27%). Drug-related grade ⩾3 AEs included neutropenia (20%), thrombocytopenia (13%) and diarrhea (10%). Drug-related peripheral neuropathy occurred in four (13%) patients; no grade ⩾3 events were reported. Plasma exposure increased dose proportionally from 0.5−3.11 mg/m
2
; terminal half-life was 4−12 days after multiple dosing. Of 26 evaluable patients, five achieved responses: 4/11 follicular lymphoma patients (one complete and three partial responses) and 1/4 peripheral T-cell lymphoma patients (partial response). Sustained responses were observed with ⩾32 cycles of treatment in two heavily pretreated follicular lymphoma patients. Results suggest weekly IV ixazomib is generally well tolerated and may be clinically active in relapsed/refractory lymphoma.</description><identifier>ISSN: 2044-5385</identifier><identifier>EISSN: 2044-5385</identifier><identifier>DOI: 10.1038/bcj.2014.71</identifier><identifier>PMID: 25325301</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>692/308/2778 ; 692/700/565 ; Adult ; Aged ; Biomedical and Life Sciences ; Biomedicine ; Boron Compounds - administration & dosage ; Boron Compounds - adverse effects ; Cancer Research ; Diarrhea - chemically induced ; Diarrhea - epidemiology ; Female ; Glycine - administration & dosage ; Glycine - adverse effects ; Glycine - analogs & derivatives ; Hematology ; Humans ; Lymphoma, Follicular - drug therapy ; Lymphoma, Follicular - epidemiology ; Lymphoma, T-Cell, Peripheral - drug therapy ; Lymphoma, T-Cell, Peripheral - epidemiology ; Male ; Middle Aged ; Neutropenia - chemically induced ; Neutropenia - epidemiology ; Oncology ; Original ; original-article ; Peripheral Nervous System Diseases - chemically induced ; Peripheral Nervous System Diseases - epidemiology ; Proteasome Inhibitors - administration & dosage ; Proteasome Inhibitors - adverse effects ; Thrombocytopenia - chemically induced ; Thrombocytopenia - epidemiology</subject><ispartof>Blood cancer journal (New York), 2014-10, Vol.4 (10), p.e251-e251</ispartof><rights>The Author(s) 2014</rights><rights>Copyright Nature Publishing Group Oct 2014</rights><rights>Copyright © 2014 Macmillan Publishers Limited 2014 Macmillan Publishers Limited</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c446t-56887c282e96973bf79f1d05b4269f0e7faae41bed3ca4f08db4bcbe44b337ef3</citedby><cites>FETCH-LOGICAL-c446t-56887c282e96973bf79f1d05b4269f0e7faae41bed3ca4f08db4bcbe44b337ef3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4220649/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4220649/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,27924,27925,41120,42189,51576,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25325301$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Assouline, S E</creatorcontrib><creatorcontrib>Chang, J</creatorcontrib><creatorcontrib>Cheson, B D</creatorcontrib><creatorcontrib>Rifkin, R</creatorcontrib><creatorcontrib>Hamburg, S</creatorcontrib><creatorcontrib>Reyes, R</creatorcontrib><creatorcontrib>Hui, A-M</creatorcontrib><creatorcontrib>Yu, J</creatorcontrib><creatorcontrib>Gupta, N</creatorcontrib><creatorcontrib>Di Bacco, A</creatorcontrib><creatorcontrib>Shou, Y</creatorcontrib><creatorcontrib>Martin, P</creatorcontrib><title>Phase 1 dose-escalation study of IV ixazomib, an investigational proteasome inhibitor, in patients with relapsed/refractory lymphoma</title><title>Blood cancer journal (New York)</title><addtitle>Blood Cancer Journal</addtitle><addtitle>Blood Cancer J</addtitle><description>Ixazomib is an investigational proteasome inhibitor that has shown preclinical activity in lymphoma models. This phase 1 study assessed the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics, pharmacodynamics and preliminary activity of intravenous (IV) ixazomib in relapsed/refractory lymphoma patients who had received ⩾2 prior therapies. Thirty patients with a range of histologies received ixazomib 0.125−3.11 mg/m
2
on days 1, 8 and 15 of 28-day cycles. Patients received a median of two cycles (range 1−36). MTD was determined to be 2.34 mg/m
2
. Most common drug-related adverse events (AEs) included fatigue (43%), diarrhea (33%), nausea, vomiting and thrombocytopenia (each 27%). Drug-related grade ⩾3 AEs included neutropenia (20%), thrombocytopenia (13%) and diarrhea (10%). Drug-related peripheral neuropathy occurred in four (13%) patients; no grade ⩾3 events were reported. Plasma exposure increased dose proportionally from 0.5−3.11 mg/m
2
; terminal half-life was 4−12 days after multiple dosing. Of 26 evaluable patients, five achieved responses: 4/11 follicular lymphoma patients (one complete and three partial responses) and 1/4 peripheral T-cell lymphoma patients (partial response). Sustained responses were observed with ⩾32 cycles of treatment in two heavily pretreated follicular lymphoma patients. Results suggest weekly IV ixazomib is generally well tolerated and may be clinically active in relapsed/refractory lymphoma.</description><subject>692/308/2778</subject><subject>692/700/565</subject><subject>Adult</subject><subject>Aged</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Boron Compounds - administration & dosage</subject><subject>Boron Compounds - adverse effects</subject><subject>Cancer Research</subject><subject>Diarrhea - chemically induced</subject><subject>Diarrhea - epidemiology</subject><subject>Female</subject><subject>Glycine - administration & dosage</subject><subject>Glycine - adverse effects</subject><subject>Glycine - analogs & derivatives</subject><subject>Hematology</subject><subject>Humans</subject><subject>Lymphoma, Follicular - drug therapy</subject><subject>Lymphoma, Follicular - epidemiology</subject><subject>Lymphoma, T-Cell, Peripheral - drug therapy</subject><subject>Lymphoma, T-Cell, Peripheral - epidemiology</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Neutropenia - chemically induced</subject><subject>Neutropenia - epidemiology</subject><subject>Oncology</subject><subject>Original</subject><subject>original-article</subject><subject>Peripheral Nervous System Diseases - chemically induced</subject><subject>Peripheral Nervous System Diseases - epidemiology</subject><subject>Proteasome Inhibitors - administration & dosage</subject><subject>Proteasome Inhibitors - adverse effects</subject><subject>Thrombocytopenia - chemically induced</subject><subject>Thrombocytopenia - epidemiology</subject><issn>2044-5385</issn><issn>2044-5385</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNptkc9rFDEcxYMottSevEvAi9CdbZLJZCYXQYo_CgV7UK8hyXyzk2VmMiYztevZP9zUrWWVhkC-8D68PL4PoZeUrCkpm3Njt2tGKF_X9Ak6ZoTzoiqb6unBfIROU9qSfCpBJZXP0RGrynwJPUa_rjudAFPchgQFJKt7Pfsw4jQv7Q4Hhy-_YX-rf4bBmxXWI_bjDaTZb_5gusdTDDPoFAbIUueNn0Nc5RFPmYBxTviHnzscoddTgvY8govaZmiH-90wdWHQL9Azp_sEp_fvCfr64f2Xi0_F1eePlxfvrgrLuZiLSjRNbVnDQApZl8bV0tGWVIYzIR2B2mkNnBpoS6u5I01ruLEGODdlWYMrT9Dbve-0mAFam9NF3asp-kHHnQraq3-V0XdqE24UZ4wILrPBm3uDGL4veQ1q8MlC3-sRwpIUFZQLKRpSZ_T1f-g2LDEvLFN1wyWrqoZl6mxP2RhSyqt5CEOJuitY5YLVXcGqppl-dZj_gf1bZwZWeyBladxAPPj0Eb_fnpSzLA</recordid><startdate>20141017</startdate><enddate>20141017</enddate><creator>Assouline, S E</creator><creator>Chang, J</creator><creator>Cheson, B D</creator><creator>Rifkin, R</creator><creator>Hamburg, S</creator><creator>Reyes, R</creator><creator>Hui, A-M</creator><creator>Yu, J</creator><creator>Gupta, N</creator><creator>Di Bacco, A</creator><creator>Shou, Y</creator><creator>Martin, P</creator><general>Nature Publishing Group UK</general><general>Springer Nature B.V</general><general>Nature Publishing Group</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20141017</creationdate><title>Phase 1 dose-escalation study of IV ixazomib, an investigational proteasome inhibitor, in patients with relapsed/refractory lymphoma</title><author>Assouline, S E ; Chang, J ; Cheson, B D ; Rifkin, R ; Hamburg, S ; Reyes, R ; Hui, A-M ; Yu, J ; Gupta, N ; Di Bacco, A ; Shou, Y ; Martin, P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c446t-56887c282e96973bf79f1d05b4269f0e7faae41bed3ca4f08db4bcbe44b337ef3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>692/308/2778</topic><topic>692/700/565</topic><topic>Adult</topic><topic>Aged</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Boron Compounds - administration & dosage</topic><topic>Boron Compounds - adverse effects</topic><topic>Cancer Research</topic><topic>Diarrhea - chemically induced</topic><topic>Diarrhea - epidemiology</topic><topic>Female</topic><topic>Glycine - administration & dosage</topic><topic>Glycine - adverse effects</topic><topic>Glycine - analogs & derivatives</topic><topic>Hematology</topic><topic>Humans</topic><topic>Lymphoma, Follicular - drug therapy</topic><topic>Lymphoma, Follicular - epidemiology</topic><topic>Lymphoma, T-Cell, Peripheral - drug therapy</topic><topic>Lymphoma, T-Cell, Peripheral - epidemiology</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Neutropenia - chemically induced</topic><topic>Neutropenia - epidemiology</topic><topic>Oncology</topic><topic>Original</topic><topic>original-article</topic><topic>Peripheral Nervous System Diseases - chemically induced</topic><topic>Peripheral Nervous System Diseases - epidemiology</topic><topic>Proteasome Inhibitors - administration & dosage</topic><topic>Proteasome Inhibitors - adverse effects</topic><topic>Thrombocytopenia - chemically induced</topic><topic>Thrombocytopenia - epidemiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Assouline, S E</creatorcontrib><creatorcontrib>Chang, J</creatorcontrib><creatorcontrib>Cheson, B D</creatorcontrib><creatorcontrib>Rifkin, R</creatorcontrib><creatorcontrib>Hamburg, S</creatorcontrib><creatorcontrib>Reyes, R</creatorcontrib><creatorcontrib>Hui, A-M</creatorcontrib><creatorcontrib>Yu, J</creatorcontrib><creatorcontrib>Gupta, N</creatorcontrib><creatorcontrib>Di Bacco, A</creatorcontrib><creatorcontrib>Shou, Y</creatorcontrib><creatorcontrib>Martin, P</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Blood cancer journal (New York)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Assouline, S E</au><au>Chang, J</au><au>Cheson, B D</au><au>Rifkin, R</au><au>Hamburg, S</au><au>Reyes, R</au><au>Hui, A-M</au><au>Yu, J</au><au>Gupta, N</au><au>Di Bacco, A</au><au>Shou, Y</au><au>Martin, P</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase 1 dose-escalation study of IV ixazomib, an investigational proteasome inhibitor, in patients with relapsed/refractory lymphoma</atitle><jtitle>Blood cancer journal (New York)</jtitle><stitle>Blood Cancer Journal</stitle><addtitle>Blood Cancer J</addtitle><date>2014-10-17</date><risdate>2014</risdate><volume>4</volume><issue>10</issue><spage>e251</spage><epage>e251</epage><pages>e251-e251</pages><issn>2044-5385</issn><eissn>2044-5385</eissn><abstract>Ixazomib is an investigational proteasome inhibitor that has shown preclinical activity in lymphoma models. This phase 1 study assessed the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics, pharmacodynamics and preliminary activity of intravenous (IV) ixazomib in relapsed/refractory lymphoma patients who had received ⩾2 prior therapies. Thirty patients with a range of histologies received ixazomib 0.125−3.11 mg/m
2
on days 1, 8 and 15 of 28-day cycles. Patients received a median of two cycles (range 1−36). MTD was determined to be 2.34 mg/m
2
. Most common drug-related adverse events (AEs) included fatigue (43%), diarrhea (33%), nausea, vomiting and thrombocytopenia (each 27%). Drug-related grade ⩾3 AEs included neutropenia (20%), thrombocytopenia (13%) and diarrhea (10%). Drug-related peripheral neuropathy occurred in four (13%) patients; no grade ⩾3 events were reported. Plasma exposure increased dose proportionally from 0.5−3.11 mg/m
2
; terminal half-life was 4−12 days after multiple dosing. Of 26 evaluable patients, five achieved responses: 4/11 follicular lymphoma patients (one complete and three partial responses) and 1/4 peripheral T-cell lymphoma patients (partial response). Sustained responses were observed with ⩾32 cycles of treatment in two heavily pretreated follicular lymphoma patients. Results suggest weekly IV ixazomib is generally well tolerated and may be clinically active in relapsed/refractory lymphoma.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>25325301</pmid><doi>10.1038/bcj.2014.71</doi><oa>free_for_read</oa></addata></record> |
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| subjects | 692/308/2778 692/700/565 Adult Aged Biomedical and Life Sciences Biomedicine Boron Compounds - administration & dosage Boron Compounds - adverse effects Cancer Research Diarrhea - chemically induced Diarrhea - epidemiology Female Glycine - administration & dosage Glycine - adverse effects Glycine - analogs & derivatives Hematology Humans Lymphoma, Follicular - drug therapy Lymphoma, Follicular - epidemiology Lymphoma, T-Cell, Peripheral - drug therapy Lymphoma, T-Cell, Peripheral - epidemiology Male Middle Aged Neutropenia - chemically induced Neutropenia - epidemiology Oncology Original original-article Peripheral Nervous System Diseases - chemically induced Peripheral Nervous System Diseases - epidemiology Proteasome Inhibitors - administration & dosage Proteasome Inhibitors - adverse effects Thrombocytopenia - chemically induced Thrombocytopenia - epidemiology |
| title | Phase 1 dose-escalation study of IV ixazomib, an investigational proteasome inhibitor, in patients with relapsed/refractory lymphoma |
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