EVESOR, a model-based, multiparameter, Phase I trial to optimize the benefit/toxicity ratio of everolimus and sorafenib
This novel multiparameter Phase I study aimed to optimize doses/dosing schedules of everolimus and sorafenib drug combination, based on modeling/simulation (NCT01932177). About 26 patients with solid tumors were treated in four different dosing schedules. Everolimus once daily + sorafenib twice dail...
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| Veröffentlicht in: | Future oncology (London, England) England), 2017-04, Vol.13 (8), p.679-693 |
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| creator | El-Madani, Mévidette Colomban, Olivier Tod, Michel Maillet, Denis Peron, Julien Rodriguez-Lafrasse, Claire Badary, Osama A Valette, Pierre-Jean Lefort, Thibaud Cassier, Philippe El-Shenawy, Siham M EL-Demerdash, Ebtehal Hommel-Fontaine, Juliette Guitton, Jerome Gagnieu, Marie-Claude Ibrahim, Bassant MM Barrois, Catherine Freyer, Gilles You, Benoit |
| description | This novel multiparameter Phase I study aimed to optimize doses/dosing schedules of everolimus and sorafenib drug combination, based on modeling/simulation (NCT01932177).
About 26 patients with solid tumors were treated in four different dosing schedules. Everolimus once daily + sorafenib twice daily were given continuously in arms A and B, and intermittently in arms C (alternating every other week) and D (everolimus continuous and sorafenib 3 days on/4 days off).
Continuous schedules exhibited higher toxicity risks than intermittent schedules (64.1 vs 35.9%; p < 0.0001), and trends for lower disease control rates (80 vs 100%). No significant pharmacokinetic interaction was identified.
Feasibility of EVESOR trial is demonstrated. Intermittent schedules might provide better tolerance and efficacy than continuous schedules. |
| doi_str_mv | 10.2217/fon-2016-0357 |
| format | Article |
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About 26 patients with solid tumors were treated in four different dosing schedules. Everolimus once daily + sorafenib twice daily were given continuously in arms A and B, and intermittently in arms C (alternating every other week) and D (everolimus continuous and sorafenib 3 days on/4 days off).
Continuous schedules exhibited higher toxicity risks than intermittent schedules (64.1 vs 35.9%; p < 0.0001), and trends for lower disease control rates (80 vs 100%). No significant pharmacokinetic interaction was identified.
Feasibility of EVESOR trial is demonstrated. Intermittent schedules might provide better tolerance and efficacy than continuous schedules.</description><identifier>ISSN: 1479-6694</identifier><identifier>EISSN: 1744-8301</identifier><identifier>DOI: 10.2217/fon-2016-0357</identifier><identifier>PMID: 28076966</identifier><language>eng</language><publisher>England: Future Medicine Ltd</publisher><subject>administration and dosage ; Adult ; adverse events ; Aged ; angiogenesis inhibitors ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Cancer therapies ; Clinical trials ; Data analysis ; Drug Administration Schedule ; Drug dosages ; everolimus ; Everolimus - administration & dosage ; Everolimus - pharmacokinetics ; Female ; Humans ; Kidney cancer ; Magnetic Resonance Imaging ; Male ; Mathematical models ; maximum tolerated dose ; Medical prognosis ; Metastasis ; Middle Aged ; modeling ; Neoplasms - diagnosis ; Neoplasms - drug therapy ; Niacinamide - administration & dosage ; Niacinamide - analogs & derivatives ; Niacinamide - pharmacokinetics ; pharmacokinetics ; Phase I ; Phenylurea Compounds - administration & dosage ; Phenylurea Compounds - pharmacokinetics ; Population ; Protein Kinase Inhibitors - administration & dosage ; Schedules ; solid tumor ; sorafenib ; Targeted cancer therapy ; targeted therapy ; Tomography, X-Ray Computed ; Treatment Outcome ; Tumors</subject><ispartof>Future oncology (London, England), 2017-04, Vol.13 (8), p.679-693</ispartof><rights>Future Medicine Ltd</rights><rights>Copyright Future Medicine Ltd Apr 2017</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c371t-84262e904e9d51e30eebc344836e810fba90541ad77ea44e7c7f8c2b5112d9233</citedby><cites>FETCH-LOGICAL-c371t-84262e904e9d51e30eebc344836e810fba90541ad77ea44e7c7f8c2b5112d9233</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,781,785,27929,27930</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28076966$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>El-Madani, Mévidette</creatorcontrib><creatorcontrib>Colomban, Olivier</creatorcontrib><creatorcontrib>Tod, Michel</creatorcontrib><creatorcontrib>Maillet, Denis</creatorcontrib><creatorcontrib>Peron, Julien</creatorcontrib><creatorcontrib>Rodriguez-Lafrasse, Claire</creatorcontrib><creatorcontrib>Badary, Osama A</creatorcontrib><creatorcontrib>Valette, Pierre-Jean</creatorcontrib><creatorcontrib>Lefort, Thibaud</creatorcontrib><creatorcontrib>Cassier, Philippe</creatorcontrib><creatorcontrib>El-Shenawy, Siham M</creatorcontrib><creatorcontrib>EL-Demerdash, Ebtehal</creatorcontrib><creatorcontrib>Hommel-Fontaine, Juliette</creatorcontrib><creatorcontrib>Guitton, Jerome</creatorcontrib><creatorcontrib>Gagnieu, Marie-Claude</creatorcontrib><creatorcontrib>Ibrahim, Bassant MM</creatorcontrib><creatorcontrib>Barrois, Catherine</creatorcontrib><creatorcontrib>Freyer, Gilles</creatorcontrib><creatorcontrib>You, Benoit</creatorcontrib><title>EVESOR, a model-based, multiparameter, Phase I trial to optimize the benefit/toxicity ratio of everolimus and sorafenib</title><title>Future oncology (London, England)</title><addtitle>Future Oncol</addtitle><description>This novel multiparameter Phase I study aimed to optimize doses/dosing schedules of everolimus and sorafenib drug combination, based on modeling/simulation (NCT01932177).
About 26 patients with solid tumors were treated in four different dosing schedules. Everolimus once daily + sorafenib twice daily were given continuously in arms A and B, and intermittently in arms C (alternating every other week) and D (everolimus continuous and sorafenib 3 days on/4 days off).
Continuous schedules exhibited higher toxicity risks than intermittent schedules (64.1 vs 35.9%; p < 0.0001), and trends for lower disease control rates (80 vs 100%). No significant pharmacokinetic interaction was identified.
Feasibility of EVESOR trial is demonstrated. Intermittent schedules might provide better tolerance and efficacy than continuous schedules.</description><subject>administration and dosage</subject><subject>Adult</subject><subject>adverse events</subject><subject>Aged</subject><subject>angiogenesis inhibitors</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Cancer therapies</subject><subject>Clinical trials</subject><subject>Data analysis</subject><subject>Drug Administration Schedule</subject><subject>Drug dosages</subject><subject>everolimus</subject><subject>Everolimus - administration & dosage</subject><subject>Everolimus - pharmacokinetics</subject><subject>Female</subject><subject>Humans</subject><subject>Kidney cancer</subject><subject>Magnetic Resonance Imaging</subject><subject>Male</subject><subject>Mathematical models</subject><subject>maximum tolerated dose</subject><subject>Medical prognosis</subject><subject>Metastasis</subject><subject>Middle Aged</subject><subject>modeling</subject><subject>Neoplasms - diagnosis</subject><subject>Neoplasms - drug therapy</subject><subject>Niacinamide - administration & dosage</subject><subject>Niacinamide - analogs & derivatives</subject><subject>Niacinamide - pharmacokinetics</subject><subject>pharmacokinetics</subject><subject>Phase I</subject><subject>Phenylurea Compounds - administration & dosage</subject><subject>Phenylurea Compounds - pharmacokinetics</subject><subject>Population</subject><subject>Protein Kinase Inhibitors - administration & dosage</subject><subject>Schedules</subject><subject>solid tumor</subject><subject>sorafenib</subject><subject>Targeted cancer therapy</subject><subject>targeted therapy</subject><subject>Tomography, X-Ray Computed</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><issn>1479-6694</issn><issn>1744-8301</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kEtr3DAURkVJ6EzSLrstgmxHjV6W7GUZpk0gkJKk3QrZviIabGsqyXn010fDpNlldR-c-104CH1h9BvnTJ-7MBFOmSJUVPoDWjItJakFZUell7ohSjVygU5S2lIqtajoR7TgNdWqUWqJHjd_NrfXNyts8Rh6GEhrE_QrPM5D9jsb7QgZ4gr_ui97fIlz9HbAOeCwy370_wDne8AtTOB8Ps_hyXc-P-Nosy-Mw_AAMQx-nBO2U49TiNbB5NtP6NjZIcHn13qKfv_Y3K0vyNX1z8v19yvSCc0yqSVXHBoqoekrBoICtJ2QshYKakZdaxtaSWZ7rcFKCbrTru54WzHG-4YLcYrODrm7GP7OkLLZhjlO5aXhXFe1YlrVhSIHqoshpQjO7KIfbXw2jJq9ZlM0m71ms9dc-K-vqXM7Qv9G__dagOYAuDnPEVLnYerAHKZyUSxN8E74CzwyjCY</recordid><startdate>20170401</startdate><enddate>20170401</enddate><creator>El-Madani, Mévidette</creator><creator>Colomban, Olivier</creator><creator>Tod, Michel</creator><creator>Maillet, Denis</creator><creator>Peron, Julien</creator><creator>Rodriguez-Lafrasse, Claire</creator><creator>Badary, Osama A</creator><creator>Valette, Pierre-Jean</creator><creator>Lefort, Thibaud</creator><creator>Cassier, Philippe</creator><creator>El-Shenawy, Siham M</creator><creator>EL-Demerdash, Ebtehal</creator><creator>Hommel-Fontaine, Juliette</creator><creator>Guitton, Jerome</creator><creator>Gagnieu, Marie-Claude</creator><creator>Ibrahim, Bassant MM</creator><creator>Barrois, Catherine</creator><creator>Freyer, Gilles</creator><creator>You, Benoit</creator><general>Future Medicine Ltd</general><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>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>EHMNL</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope></search><sort><creationdate>20170401</creationdate><title>EVESOR, a model-based, multiparameter, Phase I trial to optimize the benefit/toxicity ratio of everolimus and sorafenib</title><author>El-Madani, Mévidette ; Colomban, Olivier ; Tod, Michel ; Maillet, Denis ; Peron, Julien ; Rodriguez-Lafrasse, Claire ; Badary, Osama A ; Valette, Pierre-Jean ; Lefort, Thibaud ; Cassier, Philippe ; El-Shenawy, Siham M ; EL-Demerdash, Ebtehal ; Hommel-Fontaine, Juliette ; Guitton, Jerome ; Gagnieu, Marie-Claude ; Ibrahim, Bassant MM ; Barrois, Catherine ; Freyer, Gilles ; You, Benoit</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c371t-84262e904e9d51e30eebc344836e810fba90541ad77ea44e7c7f8c2b5112d9233</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>administration and dosage</topic><topic>Adult</topic><topic>adverse events</topic><topic>Aged</topic><topic>angiogenesis inhibitors</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Cancer therapies</topic><topic>Clinical trials</topic><topic>Data analysis</topic><topic>Drug Administration Schedule</topic><topic>Drug dosages</topic><topic>everolimus</topic><topic>Everolimus - administration & dosage</topic><topic>Everolimus - pharmacokinetics</topic><topic>Female</topic><topic>Humans</topic><topic>Kidney cancer</topic><topic>Magnetic Resonance Imaging</topic><topic>Male</topic><topic>Mathematical models</topic><topic>maximum tolerated dose</topic><topic>Medical prognosis</topic><topic>Metastasis</topic><topic>Middle Aged</topic><topic>modeling</topic><topic>Neoplasms - diagnosis</topic><topic>Neoplasms - drug therapy</topic><topic>Niacinamide - administration & dosage</topic><topic>Niacinamide - analogs & derivatives</topic><topic>Niacinamide - pharmacokinetics</topic><topic>pharmacokinetics</topic><topic>Phase I</topic><topic>Phenylurea Compounds - administration & dosage</topic><topic>Phenylurea Compounds - pharmacokinetics</topic><topic>Population</topic><topic>Protein Kinase Inhibitors - administration & dosage</topic><topic>Schedules</topic><topic>solid tumor</topic><topic>sorafenib</topic><topic>Targeted cancer therapy</topic><topic>targeted therapy</topic><topic>Tomography, X-Ray Computed</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>El-Madani, Mévidette</creatorcontrib><creatorcontrib>Colomban, Olivier</creatorcontrib><creatorcontrib>Tod, Michel</creatorcontrib><creatorcontrib>Maillet, Denis</creatorcontrib><creatorcontrib>Peron, Julien</creatorcontrib><creatorcontrib>Rodriguez-Lafrasse, Claire</creatorcontrib><creatorcontrib>Badary, Osama A</creatorcontrib><creatorcontrib>Valette, Pierre-Jean</creatorcontrib><creatorcontrib>Lefort, Thibaud</creatorcontrib><creatorcontrib>Cassier, Philippe</creatorcontrib><creatorcontrib>El-Shenawy, Siham M</creatorcontrib><creatorcontrib>EL-Demerdash, Ebtehal</creatorcontrib><creatorcontrib>Hommel-Fontaine, Juliette</creatorcontrib><creatorcontrib>Guitton, Jerome</creatorcontrib><creatorcontrib>Gagnieu, Marie-Claude</creatorcontrib><creatorcontrib>Ibrahim, Bassant MM</creatorcontrib><creatorcontrib>Barrois, Catherine</creatorcontrib><creatorcontrib>Freyer, Gilles</creatorcontrib><creatorcontrib>You, Benoit</creatorcontrib><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>ProQuest Pharma Collection</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</collection><collection>ProQuest One Community College</collection><collection>UK & Ireland Database</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>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><jtitle>Future oncology (London, England)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>El-Madani, Mévidette</au><au>Colomban, Olivier</au><au>Tod, Michel</au><au>Maillet, Denis</au><au>Peron, Julien</au><au>Rodriguez-Lafrasse, Claire</au><au>Badary, Osama A</au><au>Valette, Pierre-Jean</au><au>Lefort, Thibaud</au><au>Cassier, Philippe</au><au>El-Shenawy, Siham M</au><au>EL-Demerdash, Ebtehal</au><au>Hommel-Fontaine, Juliette</au><au>Guitton, Jerome</au><au>Gagnieu, Marie-Claude</au><au>Ibrahim, Bassant MM</au><au>Barrois, Catherine</au><au>Freyer, Gilles</au><au>You, Benoit</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>EVESOR, a model-based, multiparameter, Phase I trial to optimize the benefit/toxicity ratio of everolimus and sorafenib</atitle><jtitle>Future oncology (London, England)</jtitle><addtitle>Future Oncol</addtitle><date>2017-04-01</date><risdate>2017</risdate><volume>13</volume><issue>8</issue><spage>679</spage><epage>693</epage><pages>679-693</pages><issn>1479-6694</issn><eissn>1744-8301</eissn><abstract>This novel multiparameter Phase I study aimed to optimize doses/dosing schedules of everolimus and sorafenib drug combination, based on modeling/simulation (NCT01932177).
About 26 patients with solid tumors were treated in four different dosing schedules. Everolimus once daily + sorafenib twice daily were given continuously in arms A and B, and intermittently in arms C (alternating every other week) and D (everolimus continuous and sorafenib 3 days on/4 days off).
Continuous schedules exhibited higher toxicity risks than intermittent schedules (64.1 vs 35.9%; p < 0.0001), and trends for lower disease control rates (80 vs 100%). No significant pharmacokinetic interaction was identified.
Feasibility of EVESOR trial is demonstrated. Intermittent schedules might provide better tolerance and efficacy than continuous schedules.</abstract><cop>England</cop><pub>Future Medicine Ltd</pub><pmid>28076966</pmid><doi>10.2217/fon-2016-0357</doi><tpages>15</tpages></addata></record> |
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| ispartof | Future oncology (London, England), 2017-04, Vol.13 (8), p.679-693 |
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| subjects | administration and dosage Adult adverse events Aged angiogenesis inhibitors Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Cancer therapies Clinical trials Data analysis Drug Administration Schedule Drug dosages everolimus Everolimus - administration & dosage Everolimus - pharmacokinetics Female Humans Kidney cancer Magnetic Resonance Imaging Male Mathematical models maximum tolerated dose Medical prognosis Metastasis Middle Aged modeling Neoplasms - diagnosis Neoplasms - drug therapy Niacinamide - administration & dosage Niacinamide - analogs & derivatives Niacinamide - pharmacokinetics pharmacokinetics Phase I Phenylurea Compounds - administration & dosage Phenylurea Compounds - pharmacokinetics Population Protein Kinase Inhibitors - administration & dosage Schedules solid tumor sorafenib Targeted cancer therapy targeted therapy Tomography, X-Ray Computed Treatment Outcome Tumors |
| title | EVESOR, a model-based, multiparameter, Phase I trial to optimize the benefit/toxicity ratio of everolimus and sorafenib |
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