A Randomized, Double-Blind, Placebo-Controlled Phase II Study of the Efficacy and Safety of Monotherapy Ontuxizumab (MORAb-004) Plus Best Supportive Care in Patients with Chemorefractory Metastatic Colorectal Cancer
The purpose of this study was to evaluate the safety and efficacy of ontuxizumab (MORAb-004), a monoclonal antibody that interferes with endosialin (tumor endothelial marker-1) function, in patients with chemorefractory metastatic colorectal cancer and to identify a responsive patient population bas...
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| Veröffentlicht in: | Clinical cancer research 2018-01, Vol.24 (2), p.316-325 |
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| creator | Grothey, Axel Strosberg, Jonathan R Renfro, Lindsay A Hurwitz, Herbert I Marshall, John L Safran, Howard Guarino, Michael J Kim, George P Hecht, J R Weil, Susan C Heyburn, John Wang, Wenquan Schweizer, Charles O'Shannessy, Daniel J Diaz, Jr, Luis Alberto |
| description | The purpose of this study was to evaluate the safety and efficacy of ontuxizumab (MORAb-004), a monoclonal antibody that interferes with endosialin (tumor endothelial marker-1) function, in patients with chemorefractory metastatic colorectal cancer and to identify a responsive patient population based on biomarkers.
This was a randomized, double-blind, placebo-controlled, phase II study. Patients were randomly assigned in a 2:1 ratio to receive weekly intravenous ontuxizumab (8 mg/kg) or placebo plus best supportive care until progression or unacceptable toxicity. Tissue and blood biomarkers were evaluated for their ability to identify a patient population that was responsive to ontuxizumab.
A total of 126 patients were enrolled. No significant difference between the ontuxizumab and placebo groups was evident for the primary endpoint of progression-free survival (PFS), with a median PFS of 8.1 weeks in each group (HR, 1.13; 95% confidence interval, 0.76-1.67;
= 0.53). There were no significant differences between groups for overall survival (OS) or overall response rate (ORR). The most common treatment-emergent adverse events (TEAEs) in the ontuxizumab group (vs. the placebo group, respectively) were fatigue (53.7% vs. 47.5%), nausea (39.0% vs. 35.0%), decreased appetite (34.1% vs. 27.5%), and constipation (28.0% vs. 32.5%). The most common grade 3/4 TEAE in the ontuxizumab group versus placebo was back pain (11.0% vs. 0%). No single biomarker clearly identified patients responsive to ontuxizumab.
No benefit with ontuxizumab monotherapy compared with placebo for clinical response parameters of PFS, OS, or ORR was demonstrated. Ontuxizumab was well tolerated.
. |
| doi_str_mv | 10.1158/1078-0432.CCR-17-1558 |
| format | Article |
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This was a randomized, double-blind, placebo-controlled, phase II study. Patients were randomly assigned in a 2:1 ratio to receive weekly intravenous ontuxizumab (8 mg/kg) or placebo plus best supportive care until progression or unacceptable toxicity. Tissue and blood biomarkers were evaluated for their ability to identify a patient population that was responsive to ontuxizumab.
A total of 126 patients were enrolled. No significant difference between the ontuxizumab and placebo groups was evident for the primary endpoint of progression-free survival (PFS), with a median PFS of 8.1 weeks in each group (HR, 1.13; 95% confidence interval, 0.76-1.67;
= 0.53). There were no significant differences between groups for overall survival (OS) or overall response rate (ORR). The most common treatment-emergent adverse events (TEAEs) in the ontuxizumab group (vs. the placebo group, respectively) were fatigue (53.7% vs. 47.5%), nausea (39.0% vs. 35.0%), decreased appetite (34.1% vs. 27.5%), and constipation (28.0% vs. 32.5%). The most common grade 3/4 TEAE in the ontuxizumab group versus placebo was back pain (11.0% vs. 0%). No single biomarker clearly identified patients responsive to ontuxizumab.
No benefit with ontuxizumab monotherapy compared with placebo for clinical response parameters of PFS, OS, or ORR was demonstrated. Ontuxizumab was well tolerated.
.</description><identifier>ISSN: 1078-0432</identifier><identifier>EISSN: 1557-3265</identifier><identifier>DOI: 10.1158/1078-0432.CCR-17-1558</identifier><identifier>PMID: 29084918</identifier><language>eng</language><publisher>United States: American Association for Cancer Research Inc</publisher><subject>Adult ; Aged ; Antibodies, Monoclonal, Humanized - administration & dosage ; Antibodies, Monoclonal, Humanized - adverse effects ; Antibodies, Monoclonal, Humanized - therapeutic use ; Antineoplastic Agents, Immunological - administration & dosage ; Antineoplastic Agents, Immunological - adverse effects ; Antineoplastic Agents, Immunological - therapeutic use ; Appetite loss ; Back pain ; Biomarkers ; Cancer ; Clinical trials ; Colorectal cancer ; Colorectal carcinoma ; Colorectal Neoplasms - metabolism ; Colorectal Neoplasms - mortality ; Colorectal Neoplasms - pathology ; Colorectal Neoplasms - therapy ; Combined Modality Therapy ; Confidence intervals ; Constipation ; Double-blind studies ; Drug Resistance, Neoplasm ; Experimental design ; Fatigue ; Female ; Humans ; Intravenous administration ; Kaplan-Meier Estimate ; Male ; Metastases ; Metastasis ; Middle Aged ; Monoclonal antibodies ; Nausea ; Neoplasm Metastasis ; Neoplasm Staging ; Odds Ratio ; Pain ; Palliative Care ; Patients ; Randomization ; Safety ; Survival ; Toxicity ; Treatment Outcome</subject><ispartof>Clinical cancer research, 2018-01, Vol.24 (2), p.316-325</ispartof><rights>2017 American Association for Cancer Research.</rights><rights>Copyright American Association for Cancer Research Inc Jan 15, 2018</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c384t-4c4aa4e1b3a2176855357a5195c4b5061280a3f970679e98184bf425905e3fd63</citedby><cites>FETCH-LOGICAL-c384t-4c4aa4e1b3a2176855357a5195c4b5061280a3f970679e98184bf425905e3fd63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,3343,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29084918$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Grothey, Axel</creatorcontrib><creatorcontrib>Strosberg, Jonathan R</creatorcontrib><creatorcontrib>Renfro, Lindsay A</creatorcontrib><creatorcontrib>Hurwitz, Herbert I</creatorcontrib><creatorcontrib>Marshall, John L</creatorcontrib><creatorcontrib>Safran, Howard</creatorcontrib><creatorcontrib>Guarino, Michael J</creatorcontrib><creatorcontrib>Kim, George P</creatorcontrib><creatorcontrib>Hecht, J R</creatorcontrib><creatorcontrib>Weil, Susan C</creatorcontrib><creatorcontrib>Heyburn, John</creatorcontrib><creatorcontrib>Wang, Wenquan</creatorcontrib><creatorcontrib>Schweizer, Charles</creatorcontrib><creatorcontrib>O'Shannessy, Daniel J</creatorcontrib><creatorcontrib>Diaz, Jr, Luis Alberto</creatorcontrib><title>A Randomized, Double-Blind, Placebo-Controlled Phase II Study of the Efficacy and Safety of Monotherapy Ontuxizumab (MORAb-004) Plus Best Supportive Care in Patients with Chemorefractory Metastatic Colorectal Cancer</title><title>Clinical cancer research</title><addtitle>Clin Cancer Res</addtitle><description>The purpose of this study was to evaluate the safety and efficacy of ontuxizumab (MORAb-004), a monoclonal antibody that interferes with endosialin (tumor endothelial marker-1) function, in patients with chemorefractory metastatic colorectal cancer and to identify a responsive patient population based on biomarkers.
This was a randomized, double-blind, placebo-controlled, phase II study. Patients were randomly assigned in a 2:1 ratio to receive weekly intravenous ontuxizumab (8 mg/kg) or placebo plus best supportive care until progression or unacceptable toxicity. Tissue and blood biomarkers were evaluated for their ability to identify a patient population that was responsive to ontuxizumab.
A total of 126 patients were enrolled. No significant difference between the ontuxizumab and placebo groups was evident for the primary endpoint of progression-free survival (PFS), with a median PFS of 8.1 weeks in each group (HR, 1.13; 95% confidence interval, 0.76-1.67;
= 0.53). There were no significant differences between groups for overall survival (OS) or overall response rate (ORR). The most common treatment-emergent adverse events (TEAEs) in the ontuxizumab group (vs. the placebo group, respectively) were fatigue (53.7% vs. 47.5%), nausea (39.0% vs. 35.0%), decreased appetite (34.1% vs. 27.5%), and constipation (28.0% vs. 32.5%). The most common grade 3/4 TEAE in the ontuxizumab group versus placebo was back pain (11.0% vs. 0%). No single biomarker clearly identified patients responsive to ontuxizumab.
No benefit with ontuxizumab monotherapy compared with placebo for clinical response parameters of PFS, OS, or ORR was demonstrated. Ontuxizumab was well tolerated.
.</description><subject>Adult</subject><subject>Aged</subject><subject>Antibodies, Monoclonal, Humanized - administration & dosage</subject><subject>Antibodies, Monoclonal, Humanized - adverse effects</subject><subject>Antibodies, Monoclonal, Humanized - therapeutic use</subject><subject>Antineoplastic Agents, Immunological - administration & dosage</subject><subject>Antineoplastic Agents, Immunological - adverse effects</subject><subject>Antineoplastic Agents, Immunological - therapeutic use</subject><subject>Appetite loss</subject><subject>Back pain</subject><subject>Biomarkers</subject><subject>Cancer</subject><subject>Clinical trials</subject><subject>Colorectal cancer</subject><subject>Colorectal carcinoma</subject><subject>Colorectal Neoplasms - metabolism</subject><subject>Colorectal Neoplasms - mortality</subject><subject>Colorectal Neoplasms - pathology</subject><subject>Colorectal Neoplasms - therapy</subject><subject>Combined Modality Therapy</subject><subject>Confidence intervals</subject><subject>Constipation</subject><subject>Double-blind studies</subject><subject>Drug Resistance, Neoplasm</subject><subject>Experimental design</subject><subject>Fatigue</subject><subject>Female</subject><subject>Humans</subject><subject>Intravenous administration</subject><subject>Kaplan-Meier Estimate</subject><subject>Male</subject><subject>Metastases</subject><subject>Metastasis</subject><subject>Middle Aged</subject><subject>Monoclonal antibodies</subject><subject>Nausea</subject><subject>Neoplasm Metastasis</subject><subject>Neoplasm Staging</subject><subject>Odds Ratio</subject><subject>Pain</subject><subject>Palliative Care</subject><subject>Patients</subject><subject>Randomization</subject><subject>Safety</subject><subject>Survival</subject><subject>Toxicity</subject><subject>Treatment Outcome</subject><issn>1078-0432</issn><issn>1557-3265</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9kc1u1DAQxyMEoqXwCKCRuICEi53YiXPchgIrdbWrXThbjjPRpkriYDtA-qK8Dl7achpb_4_R6Jckrxm9ZEzIj4wWklCepZdVtSesIEwI-SQ5j6MgWZqLp_H96DlLXnh_SynjjPLnyVlaUslLJs-TPyvY67GxQ3eHzQf4ZOe6R3LVd2P87XptsLaksmNwtu-xgd1Re4T1Gg5hbhawLYQjwnXbdkabBWIVHHSL4Z-0saONstPTAtsxzL-7u3nQNbzbbPermlDK38cds4cr9AEO8zRZF7qfCJV2CN0IOx06HIOHX104QnXEwTpsnTbBugU2GLQP0WKgsn1UTNB9zI4G3cvkWat7j68e5kXy_fP1t-orudl-WVerG2IyyQPhhmvNkdWZTlmRSyEyUWjBSmF4LWjOUkl11pYFzYsSS8kkr1ueipIKzNomzy6St_e9k7M_5niGurWzG-NKlVKayyIteRld4t5lnPU-nqAm1w3aLYpRdcKpTqjUCZWKOBUr1AlnzL15aJ_rAZv_qUd-2V_sYpwb</recordid><startdate>20180115</startdate><enddate>20180115</enddate><creator>Grothey, Axel</creator><creator>Strosberg, Jonathan R</creator><creator>Renfro, Lindsay A</creator><creator>Hurwitz, Herbert I</creator><creator>Marshall, John L</creator><creator>Safran, Howard</creator><creator>Guarino, Michael J</creator><creator>Kim, George P</creator><creator>Hecht, J R</creator><creator>Weil, Susan C</creator><creator>Heyburn, John</creator><creator>Wang, Wenquan</creator><creator>Schweizer, Charles</creator><creator>O'Shannessy, Daniel J</creator><creator>Diaz, Jr, Luis Alberto</creator><general>American Association for Cancer Research Inc</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>7QO</scope><scope>7T5</scope><scope>7TO</scope><scope>7U9</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>P64</scope></search><sort><creationdate>20180115</creationdate><title>A Randomized, Double-Blind, Placebo-Controlled Phase II Study of the Efficacy and Safety of Monotherapy Ontuxizumab (MORAb-004) Plus Best Supportive Care in Patients with Chemorefractory Metastatic Colorectal Cancer</title><author>Grothey, Axel ; Strosberg, Jonathan R ; Renfro, Lindsay A ; Hurwitz, Herbert I ; Marshall, John L ; Safran, Howard ; Guarino, Michael J ; Kim, George P ; Hecht, J R ; Weil, Susan C ; Heyburn, John ; Wang, Wenquan ; Schweizer, Charles ; O'Shannessy, Daniel J ; Diaz, Jr, Luis Alberto</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c384t-4c4aa4e1b3a2176855357a5195c4b5061280a3f970679e98184bf425905e3fd63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antibodies, Monoclonal, Humanized - 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This was a randomized, double-blind, placebo-controlled, phase II study. Patients were randomly assigned in a 2:1 ratio to receive weekly intravenous ontuxizumab (8 mg/kg) or placebo plus best supportive care until progression or unacceptable toxicity. Tissue and blood biomarkers were evaluated for their ability to identify a patient population that was responsive to ontuxizumab.
A total of 126 patients were enrolled. No significant difference between the ontuxizumab and placebo groups was evident for the primary endpoint of progression-free survival (PFS), with a median PFS of 8.1 weeks in each group (HR, 1.13; 95% confidence interval, 0.76-1.67;
= 0.53). There were no significant differences between groups for overall survival (OS) or overall response rate (ORR). The most common treatment-emergent adverse events (TEAEs) in the ontuxizumab group (vs. the placebo group, respectively) were fatigue (53.7% vs. 47.5%), nausea (39.0% vs. 35.0%), decreased appetite (34.1% vs. 27.5%), and constipation (28.0% vs. 32.5%). The most common grade 3/4 TEAE in the ontuxizumab group versus placebo was back pain (11.0% vs. 0%). No single biomarker clearly identified patients responsive to ontuxizumab.
No benefit with ontuxizumab monotherapy compared with placebo for clinical response parameters of PFS, OS, or ORR was demonstrated. Ontuxizumab was well tolerated.
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| fulltext | fulltext |
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| ispartof | Clinical cancer research, 2018-01, Vol.24 (2), p.316-325 |
| issn | 1078-0432 1557-3265 |
| language | eng |
| recordid | cdi_proquest_journals_2006872949 |
| source | MEDLINE; American Association for Cancer Research; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Adult Aged Antibodies, Monoclonal, Humanized - administration & dosage Antibodies, Monoclonal, Humanized - adverse effects Antibodies, Monoclonal, Humanized - therapeutic use Antineoplastic Agents, Immunological - administration & dosage Antineoplastic Agents, Immunological - adverse effects Antineoplastic Agents, Immunological - therapeutic use Appetite loss Back pain Biomarkers Cancer Clinical trials Colorectal cancer Colorectal carcinoma Colorectal Neoplasms - metabolism Colorectal Neoplasms - mortality Colorectal Neoplasms - pathology Colorectal Neoplasms - therapy Combined Modality Therapy Confidence intervals Constipation Double-blind studies Drug Resistance, Neoplasm Experimental design Fatigue Female Humans Intravenous administration Kaplan-Meier Estimate Male Metastases Metastasis Middle Aged Monoclonal antibodies Nausea Neoplasm Metastasis Neoplasm Staging Odds Ratio Pain Palliative Care Patients Randomization Safety Survival Toxicity Treatment Outcome |
| title | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of the Efficacy and Safety of Monotherapy Ontuxizumab (MORAb-004) Plus Best Supportive Care in Patients with Chemorefractory Metastatic Colorectal Cancer |
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