A Phase II Trial of Trebananib (AMG 386; IND#111071), a Selective Angiopoietin 1/2 Neutralizing Peptibody, in Patients with Persistent/Recurrent Carcinoma of the Endometrium: An NRG/Gynecologic Oncology Group Trial
Identifieur interne : 003317 ( Pmc/Corpus ); précédent : 003316; suivant : 003318A Phase II Trial of Trebananib (AMG 386; IND#111071), a Selective Angiopoietin 1/2 Neutralizing Peptibody, in Patients with Persistent/Recurrent Carcinoma of the Endometrium: An NRG/Gynecologic Oncology Group Trial
Auteurs : Kathleen N. Moore ; Michael W. Sill ; Meaghan E. Tenney ; Christopher J. Darus ; David Griffin ; Theresa L. Werner ; Peter G. Rose ; Robert BehrensSource :
- Gynecologic oncology [ 0090-8258 ] ; 2015.
Abstract
Ang1&2 (angiopoietin-1; -2) interact with Tie2 receptors on endothelial cells to mediate vascular remodeling in an angiogenesis signaling pathway distinct from the VEGF axis. Trebaninib is a peptide Fc fusion protein that binds Ang1 and 2 and prevents interaction with Tie2. The efficacy of trebananib in recurrent/persistent endometrial cancer (EC) was studied.
The primary objective was to determine the frequency of patients with objective tumor responses (ORR) and event-free survival for ≥6 months (6-month EFS) and determine toxicity of trebananib at a dose and schedule of 15mg/kg, IV QW. Recurrent/persistent EC, measurable disease, and ≤2 prior chemotherapy lines were required.
Thirty-two patients were eligible and treated. The most common histologies were G1/2 endometrioid (31%), G3 endometrioid (28%) and serous (31.3%). 78% of patients had 1 prior regimen. Patients received 1-9+ cycles of trebananib; 24 patients (75%) received ≤2 cycles. One patient had a partial response (3.1%); 8 patients had stable disease (25%) and 5 patients (15.6%) had 6 month EFS. Median progression-free survival and overall-survival were 1.97 months (90% CI 1.77-2.1) and 6.6 months (90% CI 4.01-14.75), respectively. Most common adverse events (AE) were fatigue, anemia, and GI issues. Grade 3 and 4 AEs were: GI 31 and 0%; Vascular 22 and 0%; Metabolism/nutrition 19 and 3%; General (including edema) 16 and 0%.
Trebananib has insufficient single agent activity in recurrent EC to warrant further investigation at this dose/schedule.
Url:
DOI: 10.1016/j.ygyno.2015.07.006
PubMed: 26171911
PubMed Central: 4692151
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PMC:4692151Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">A Phase II Trial of Trebananib (AMG 386; IND#111071), a Selective Angiopoietin 1/2 Neutralizing Peptibody, in Patients with Persistent/Recurrent Carcinoma of the Endometrium: An NRG/Gynecologic Oncology Group Trial</title><author><name sortKey="Moore, Kathleen N" sort="Moore, Kathleen N" uniqKey="Moore K" first="Kathleen N." last="Moore">Kathleen N. Moore</name><affiliation><nlm:aff id="A1"> Stephenson Oklahoma Cancer Center, 800 NE 10<sup>th</sup> Street, OKC, OK 73104</nlm:aff></affiliation></author><author><name sortKey="Sill, Michael W" sort="Sill, Michael W" uniqKey="Sill M" first="Michael W." last="Sill">Michael W. Sill</name><affiliation><nlm:aff id="A2"> NRG Oncology Statistics & Data Management Center; Roswell Park Cancer Institute, Elm and Carlton Streets, Buffalo, NY 14263<email>msill@gogstats.org</email></nlm:aff></affiliation></author><author><name sortKey="Tenney, Meaghan E" sort="Tenney, Meaghan E" uniqKey="Tenney M" first="Meaghan E." last="Tenney">Meaghan E. Tenney</name><affiliation><nlm:aff id="A3"> University of Chicago, 5841 S. Maryland Avenue, Chicago, IL 60637<email>mtenney@babies.bsd.uchicago.edu</email></nlm:aff></affiliation></author><author><name sortKey="Darus, Christopher J" sort="Darus, Christopher J" uniqKey="Darus C" first="Christopher J." last="Darus">Christopher J. Darus</name><affiliation><nlm:aff id="A4"> Maine Medical Center, 102 Campus Drive Unit 116, Scarborough, ME 04074<email>darusc@mmc.org</email></nlm:aff></affiliation></author><author><name sortKey="Griffin, David" sort="Griffin, David" uniqKey="Griffin D" first="David" last="Griffin">David Griffin</name><affiliation><nlm:aff id="A5"> Upstate Carolina CCOP Oncology Research, 101 East Wood Street, Spartanburg, SC 29303<email>david_griffin@bshsi.org</email></nlm:aff></affiliation></author><author><name sortKey="Werner, Theresa L" sort="Werner, Theresa L" uniqKey="Werner T" first="Theresa L." last="Werner">Theresa L. Werner</name><affiliation><nlm:aff id="A6"> Huntsman Cancer Institute, University of Utah, 2000 Circle of Hope Salt Lake City, UT 84112<email>theresa.werner@hci.utah.edu</email></nlm:aff></affiliation></author><author><name sortKey="Rose, Peter G" sort="Rose, Peter G" uniqKey="Rose P" first="Peter G." last="Rose">Peter G. Rose</name><affiliation><nlm:aff id="A7"> Cleveland Clinic Foundation, 9500 Euclid Avenue; A81; Cleveland, OH 44106<email>rosep@ccf.org</email></nlm:aff></affiliation></author><author><name sortKey="Behrens, Robert" sort="Behrens, Robert" uniqKey="Behrens R" first="Robert" last="Behrens">Robert Behrens</name><affiliation><nlm:aff id="A8"> Cancer Center of Iowa, Iowa Wide Oncology Research Coalition, 1221 Pleasant Street, suite 450; Des Moines IA 50309<email>rbehrens@cancercenterofiowa.com</email></nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26171911</idno><idno type="pmc">4692151</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4692151</idno><idno type="RBID">PMC:4692151</idno><idno type="doi">10.1016/j.ygyno.2015.07.006</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">003317</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">003317</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A Phase II Trial of Trebananib (AMG 386; IND#111071), a Selective Angiopoietin 1/2 Neutralizing Peptibody, in Patients with Persistent/Recurrent Carcinoma of the Endometrium: An NRG/Gynecologic Oncology Group Trial</title><author><name sortKey="Moore, Kathleen N" sort="Moore, Kathleen N" uniqKey="Moore K" first="Kathleen N." last="Moore">Kathleen N. Moore</name><affiliation><nlm:aff id="A1"> Stephenson Oklahoma Cancer Center, 800 NE 10<sup>th</sup> Street, OKC, OK 73104</nlm:aff></affiliation></author><author><name sortKey="Sill, Michael W" sort="Sill, Michael W" uniqKey="Sill M" first="Michael W." last="Sill">Michael W. Sill</name><affiliation><nlm:aff id="A2"> NRG Oncology Statistics & Data Management Center; Roswell Park Cancer Institute, Elm and Carlton Streets, Buffalo, NY 14263<email>msill@gogstats.org</email></nlm:aff></affiliation></author><author><name sortKey="Tenney, Meaghan E" sort="Tenney, Meaghan E" uniqKey="Tenney M" first="Meaghan E." last="Tenney">Meaghan E. Tenney</name><affiliation><nlm:aff id="A3"> University of Chicago, 5841 S. Maryland Avenue, Chicago, IL 60637<email>mtenney@babies.bsd.uchicago.edu</email></nlm:aff></affiliation></author><author><name sortKey="Darus, Christopher J" sort="Darus, Christopher J" uniqKey="Darus C" first="Christopher J." last="Darus">Christopher J. Darus</name><affiliation><nlm:aff id="A4"> Maine Medical Center, 102 Campus Drive Unit 116, Scarborough, ME 04074<email>darusc@mmc.org</email></nlm:aff></affiliation></author><author><name sortKey="Griffin, David" sort="Griffin, David" uniqKey="Griffin D" first="David" last="Griffin">David Griffin</name><affiliation><nlm:aff id="A5"> Upstate Carolina CCOP Oncology Research, 101 East Wood Street, Spartanburg, SC 29303<email>david_griffin@bshsi.org</email></nlm:aff></affiliation></author><author><name sortKey="Werner, Theresa L" sort="Werner, Theresa L" uniqKey="Werner T" first="Theresa L." last="Werner">Theresa L. Werner</name><affiliation><nlm:aff id="A6"> Huntsman Cancer Institute, University of Utah, 2000 Circle of Hope Salt Lake City, UT 84112<email>theresa.werner@hci.utah.edu</email></nlm:aff></affiliation></author><author><name sortKey="Rose, Peter G" sort="Rose, Peter G" uniqKey="Rose P" first="Peter G." last="Rose">Peter G. Rose</name><affiliation><nlm:aff id="A7"> Cleveland Clinic Foundation, 9500 Euclid Avenue; A81; Cleveland, OH 44106<email>rosep@ccf.org</email></nlm:aff></affiliation></author><author><name sortKey="Behrens, Robert" sort="Behrens, Robert" uniqKey="Behrens R" first="Robert" last="Behrens">Robert Behrens</name><affiliation><nlm:aff id="A8"> Cancer Center of Iowa, Iowa Wide Oncology Research Coalition, 1221 Pleasant Street, suite 450; Des Moines IA 50309<email>rbehrens@cancercenterofiowa.com</email></nlm:aff></affiliation></author></analytic><series><title level="j">Gynecologic oncology</title><idno type="ISSN">0090-8258</idno><idno type="eISSN">1095-6859</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Objectives</title><p id="P1">Ang1&2 (angiopoietin-1; -2) interact with Tie2 receptors on endothelial cells to mediate vascular remodeling in an angiogenesis signaling pathway distinct from the VEGF axis. Trebaninib is a peptide Fc fusion protein that binds Ang1 and 2 and prevents interaction with Tie2. The efficacy of trebananib in recurrent/persistent endometrial cancer (EC) was studied.</p></sec><sec id="S2"><title>Methods</title><p id="P2">The primary objective was to determine the frequency of patients with objective tumor responses (ORR) and event-free survival for ≥6 months (6-month EFS) and determine toxicity of trebananib at a dose and schedule of 15mg/kg, IV QW. Recurrent/persistent EC, measurable disease, and ≤2 prior chemotherapy lines were required.</p></sec><sec id="S3"><title>Results</title><p id="P3">Thirty-two patients were eligible and treated. The most common histologies were G1/2 endometrioid (31%), G3 endometrioid (28%) and serous (31.3%). 78% of patients had 1 prior regimen. Patients received 1-9+ cycles of trebananib; 24 patients (75%) received ≤2 cycles. One patient had a partial response (3.1%); 8 patients had stable disease (25%) and 5 patients (15.6%) had 6 month EFS. Median progression-free survival and overall-survival were 1.97 months (90% CI 1.77-2.1) and 6.6 months (90% CI 4.01-14.75), respectively. Most common adverse events (AE) were fatigue, anemia, and GI issues. Grade 3 and 4 AEs were: GI 31 and 0%; Vascular 22 and 0%; Metabolism/nutrition 19 and 3%; General (including edema) 16 and 0%.</p></sec><sec id="S4"><title>Conclusions</title><p id="P4">Trebananib has insufficient single agent activity in recurrent EC to warrant further investigation at this dose/schedule.</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">0365304</journal-id><journal-id journal-id-type="pubmed-jr-id">3932</journal-id><journal-id journal-id-type="nlm-ta">Gynecol Oncol</journal-id><journal-id journal-id-type="iso-abbrev">Gynecol. Oncol.</journal-id><journal-title-group><journal-title>Gynecologic oncology</journal-title></journal-title-group><issn pub-type="ppub">0090-8258</issn><issn pub-type="epub">1095-6859</issn></journal-meta><article-meta><article-id pub-id-type="pmid">26171911</article-id><article-id pub-id-type="pmc">4692151</article-id><article-id pub-id-type="doi">10.1016/j.ygyno.2015.07.006</article-id><article-id pub-id-type="manuscript">NIHMS710760</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>A Phase II Trial of Trebananib (AMG 386; IND#111071), a Selective Angiopoietin 1/2 Neutralizing Peptibody, in Patients with Persistent/Recurrent Carcinoma of the Endometrium: An NRG/Gynecologic Oncology Group Trial</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Moore</surname><given-names>Kathleen N.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Sill</surname><given-names>Michael W.</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="A2">2</xref></contrib><contrib contrib-type="author"><name><surname>Tenney</surname><given-names>Meaghan E.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A3">3</xref></contrib><contrib contrib-type="author"><name><surname>Darus</surname><given-names>Christopher J.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A4">4</xref></contrib><contrib contrib-type="author"><name><surname>Griffin</surname><given-names>David</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A5">5</xref></contrib><contrib contrib-type="author"><name><surname>Werner</surname><given-names>Theresa L.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A6">6</xref></contrib><contrib contrib-type="author"><name><surname>Rose</surname><given-names>Peter G.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A7">7</xref></contrib><contrib contrib-type="author"><name><surname>Behrens</surname><given-names>Robert</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A8">8</xref></contrib></contrib-group><aff id="A1"><label>1</label> Stephenson Oklahoma Cancer Center, 800 NE 10<sup>th</sup> Street, OKC, OK 73104</aff><aff id="A2"><label>2</label> NRG Oncology Statistics & Data Management Center; Roswell Park Cancer Institute, Elm and Carlton Streets, Buffalo, NY 14263<email>msill@gogstats.org</email></aff><aff id="A3"><label>3</label> University of Chicago, 5841 S. Maryland Avenue, Chicago, IL 60637<email>mtenney@babies.bsd.uchicago.edu</email></aff><aff id="A4"><label>4</label> Maine Medical Center, 102 Campus Drive Unit 116, Scarborough, ME 04074<email>darusc@mmc.org</email></aff><aff id="A5"><label>5</label> Upstate Carolina CCOP Oncology Research, 101 East Wood Street, Spartanburg, SC 29303<email>david_griffin@bshsi.org</email></aff><aff id="A6"><label>6</label> Huntsman Cancer Institute, University of Utah, 2000 Circle of Hope Salt Lake City, UT 84112<email>theresa.werner@hci.utah.edu</email></aff><aff id="A7"><label>7</label> Cleveland Clinic Foundation, 9500 Euclid Avenue; A81; Cleveland, OH 44106<email>rosep@ccf.org</email></aff><aff id="A8"><label>8</label> Cancer Center of Iowa, Iowa Wide Oncology Research Coalition, 1221 Pleasant Street, suite 450; Des Moines IA 50309<email>rbehrens@cancercenterofiowa.com</email></aff><author-notes><corresp id="CR1">Corresponding Author: Kathleen N. Moore, MD, Stephenson Oklahoma Cancer Center, 800 NE 10<sup>th</sup> Street, Oklahoma City, OK 73104, Phone 405-271-8707, Fax 405-271-2976, <email>Kathleen-Moore@ouhsc.edu</email></corresp></author-notes><pub-date pub-type="nihms-submitted"><day>9</day><month>12</month><year>2015</year></pub-date><pub-date pub-type="epub"><day>11</day><month>7</month><year>2015</year></pub-date><pub-date pub-type="ppub"><month>9</month><year>2015</year></pub-date><pub-date pub-type="pmc-release"><day>01</day><month>9</month><year>2016</year></pub-date><volume>138</volume><issue>3</issue><fpage>513</fpage><lpage>518</lpage><pmc-comment>elocation-id from pubmed: 10.1016/j.ygyno.2015.07.006</pmc-comment>
<abstract><sec id="S1"><title>Objectives</title><p id="P1">Ang1&2 (angiopoietin-1; -2) interact with Tie2 receptors on endothelial cells to mediate vascular remodeling in an angiogenesis signaling pathway distinct from the VEGF axis. Trebaninib is a peptide Fc fusion protein that binds Ang1 and 2 and prevents interaction with Tie2. The efficacy of trebananib in recurrent/persistent endometrial cancer (EC) was studied.</p></sec><sec id="S2"><title>Methods</title><p id="P2">The primary objective was to determine the frequency of patients with objective tumor responses (ORR) and event-free survival for ≥6 months (6-month EFS) and determine toxicity of trebananib at a dose and schedule of 15mg/kg, IV QW. Recurrent/persistent EC, measurable disease, and ≤2 prior chemotherapy lines were required.</p></sec><sec id="S3"><title>Results</title><p id="P3">Thirty-two patients were eligible and treated. The most common histologies were G1/2 endometrioid (31%), G3 endometrioid (28%) and serous (31.3%). 78% of patients had 1 prior regimen. Patients received 1-9+ cycles of trebananib; 24 patients (75%) received ≤2 cycles. One patient had a partial response (3.1%); 8 patients had stable disease (25%) and 5 patients (15.6%) had 6 month EFS. Median progression-free survival and overall-survival were 1.97 months (90% CI 1.77-2.1) and 6.6 months (90% CI 4.01-14.75), respectively. Most common adverse events (AE) were fatigue, anemia, and GI issues. Grade 3 and 4 AEs were: GI 31 and 0%; Vascular 22 and 0%; Metabolism/nutrition 19 and 3%; General (including edema) 16 and 0%.</p></sec><sec id="S4"><title>Conclusions</title><p id="P4">Trebananib has insufficient single agent activity in recurrent EC to warrant further investigation at this dose/schedule.</p></sec></abstract><kwd-group><kwd>endometrial cancer</kwd><kwd>angiogenesis</kwd><kwd>trebananib</kwd></kwd-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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