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A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb‐004) in metastatic soft‐tissue sarcomas

dc.contributor.authorJones, Robin L.
dc.contributor.authorChawla, Sant P.
dc.contributor.authorAttia, Steven
dc.contributor.authorSchöffski, Patrick
dc.contributor.authorGelderblom, Hans
dc.contributor.authorChmielowski, Bartosz
dc.contributor.authorLe Cesne, Axel
dc.contributor.authorVan Tine, Brian A.
dc.contributor.authorTrent, Jonathan C.
dc.contributor.authorPatel, Shreyaskumar
dc.contributor.authorWagner, Andrew J.
dc.contributor.authorChugh, Rashmi
dc.contributor.authorHeyburn, John W.
dc.contributor.authorWeil, Susan C.
dc.contributor.authorWang, Wenquan
dc.contributor.authorViele, Kert
dc.contributor.authorMaki, Robert G.
dc.date.accessioned2019-07-03T19:56:18Z
dc.date.availableWITHHELD_13_MONTHS
dc.date.available2019-07-03T19:56:18Z
dc.date.issued2019-07-15
dc.identifier.citationJones, Robin L.; Chawla, Sant P.; Attia, Steven; Schöffski, Patrick ; Gelderblom, Hans; Chmielowski, Bartosz; Le Cesne, Axel; Van Tine, Brian A.; Trent, Jonathan C.; Patel, Shreyaskumar; Wagner, Andrew J.; Chugh, Rashmi; Heyburn, John W.; Weil, Susan C.; Wang, Wenquan; Viele, Kert; Maki, Robert G. (2019). "A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb‐004) in metastatic soft‐tissue sarcomas." Cancer (14): 2445-2454.
dc.identifier.issn0008-543X
dc.identifier.issn1097-0142
dc.identifier.urihttps://hdl.handle.net/2027.42/149695
dc.publisherJohn Wiley & Sons Inc
dc.subject.otherMORAb‐004
dc.subject.otherendosialin
dc.subject.otherontuxizumab
dc.subject.othersarcomas
dc.subject.othertumor endothelial marker 1 (TEM‐1)
dc.titleA phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb‐004) in metastatic soft‐tissue sarcomas
dc.typeArticle
dc.rights.robotsIndexNoFollow
dc.subject.hlbsecondlevelPublic Health
dc.subject.hlbsecondlevelOncology and Hematology
dc.subject.hlbtoplevelHealth Sciences
dc.description.peerreviewedPeer Reviewed
dc.description.bitstreamurlhttps://deepblue.lib.umich.edu/bitstream/2027.42/149695/1/cncr32084_am.pdf
dc.description.bitstreamurlhttps://deepblue.lib.umich.edu/bitstream/2027.42/149695/2/cncr32084.pdf
dc.identifier.doi10.1002/cncr.32084
dc.identifier.sourceCancer
dc.identifier.citedreferenceThway K, Robertson D, Jones RL, et al. Endosialin expression in soft tissue sarcoma as a potential marker of undifferentiated mesenchymal cells. Br J Cancer. 2016; 115: 473 ‐ 479.
dc.identifier.citedreferenceRouleau C, Smale R, Fu YS, et al. Endosialin is expressed in high grade and advanced sarcomas: evidence from clinical specimens and preclinical modeling. Int J Oncol. 2011; 39: 73 ‐ 89.
dc.identifier.citedreferenceNanda A, Karim B, Peng Z, et al. Tumor endothelial marker 1 (Tem1) functions in the growth and progression of abdominal tumors. Proc Natl Acad Sci U S A. 2006; 103: 3351 ‐ 3356.
dc.identifier.citedreferenceNoujaim J, Thway K, Sheri A, et al. Histology‐driven therapy: the importance of diagnostic accuracy in guiding systemic therapy of soft tissue tumors. Int J Surg Pathol. 2016; 1: 5 ‐ 15.
dc.identifier.citedreferenceRouleau C, Curiel M, Weber W, et al. Endosialin protein expression and therapeutic target potential in human solid tumors: sarcoma versus carcinoma. Clin Cancer Res. 2008; 14: 7223 ‐ 7236.
dc.identifier.citedreferenceTomkowicz B, Rybinski K, Sebeck D, et al. Endosialin/TEM‐1/CD248 regulates pericyte proliferation through PDGF receptor signaling. Cancer Biol Ther. 2010; 11: 908 ‐ 915.
dc.identifier.citedreferenceHensley ML, Blessing JA, Mannel R, Rose PG. Fixed‐dose rate gemcitabine plus docetaxel as first‐line therapy for metastatic uterine leiomyosarcoma: a Gynecologic Oncology Group phase II trial. Gynecol Oncol. 2008; 109: 329 ‐ 334.
dc.identifier.citedreferenceBerry SM, Broglio KR, Groshen S, Berry DA. Bayesian hierarchical modeling of patient subpopulations: efficient designs of phase II oncology clinical trials. Clin Trials. 2013; 10: 720 ‐ 734.
dc.identifier.citedreferenceHollander M, Wolfe DA. Nonparametric Statistical Methods. New York, NY: John Wiley & Sons Inc; 1973.
dc.identifier.citedreferenceBrookmeyer R, Crowley J. A confidence interval for the median survival time. Biometrics. 1982; 38: 29 ‐ 41.
dc.identifier.citedreferenceDiaz LA, Coughlin CM, Weil SC, et al. A first‐in‐human phase 1 study of MORAb‐004, a monoclonal antibody to endosialin in patients with advanced solid tumors. Clin Cancer Res. 2015; 21: 1281 ‐ 1288.
dc.identifier.citedreferenceO’Shannessy DJ, Smith MF, Somers EB, et al. Novel antibody probes for the characterization of endosialin/TEM‐1. Oncotarget. 2016; 7: 69420 ‐ 69435.
dc.identifier.citedreferenceO’Shannessy DJ, Dai H, Mitchell M, et al. Endosialin and associated protein expression in soft tissue sarcomas: a potential target for anti‐endosialin therapeutic strategies. Sarcoma. 2016; 2016: 5213628. doi: 10.1155/2016/5213628
dc.identifier.citedreferenceMaki RG, Wathen JK, Patel SR, et al. Randomized phase II study of gemcitabine and docetaxel compared with gemcitabine alone in patients with metastatic soft tissue sarcomas: results of Sarcoma Alliance for Research Through Collaboration Study 002. J Clin Oncol. 2007; 25: 2755 ‐ 2763.
dc.identifier.citedreferenceRybinski K, Imtiyaz HZ, Mittica B, et al. Targeting endosialin/CD248 through antibody‐mediated internalization results in impaired pericyte maturation and dysfunctional tumor microvasculature. Oncotarget. 2015; 6: 25429 ‐ 25440.
dc.identifier.citedreferenceRouleau C, Gianolio DA, Smale R, et al. Anti‐endosialin antibody–drug conjugate: potential in sarcoma and other malignancies. Mol Cancer Ther. 2015; 14: 2081 ‐ 2089.
dc.identifier.citedreferenceDickson MA, D’Adamo DR, Keohan ML, et al. Phase II trial of gemcitabine and docetaxel with bevacizumab in soft tissue sarcoma. Sarcoma. 2015; 2015: 532478.
dc.identifier.citedreferenceHensley ML, Blessing JA, Degeest K, et al. Fixed‐dose rate gemcitabine plus docetaxel as second‐line therapy for metastatic uterine leiomyosarcoma: a Gynecologic Oncology Group phase II trial. Gynecol Oncol. 2008; 109: 323 ‐ 328.
dc.owningcollnameInterdisciplinary and Peer-Reviewed


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