Randomized, Double-Blind, Phase II Study of Ruxolitinib or Placebo in Combination With Capecitabine in Patients With Metastatic Pancreatic Cancer for Whom Therapy With Gemcitabine Has Failed.

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Herbert I HurwitzRichard S Levy

Abstract

Patients with advanced pancreatic adenocarcinoma have a poor prognosis and limited second-line treatment options. Evidence suggests a role for the Janus kinase (JAK)/signal transducer and activator of transcription pathway in the pathogenesis and clinical course of pancreatic cancer. In this double-blind, phase II study, patients with metastatic pancreatic cancer who had experienced treatment failure with gemcitabine were randomly assigned 1:1 to the JAK1/JAK2 inhibitor ruxolitinib (15 mg twice daily) plus capecitabine (1,000 mg/m(2) twice daily) or placebo plus capecitabine. The primary end point was overall survival (OS); secondary end points included progression-free survival, clinical benefit response, objective response rate, and safety. Prespecified subgroup analyses evaluated treatment heterogeneity and efficacy in patients with evidence of inflammation. In the intent-to-treat population (ruxolitinib, n = 64; placebo, n = 63), the hazard ratio was 0.79 (95% CI, 0.53 to 1.18; P = .25) for OS and was 0.75 (95% CI, 0.52 to 1.10; P = .14) for progression-free survival. In a prespecified subgroup analysis of patients with inflammation, defined by serum C-reactive protein levels greater than the study population median (ie, 13...Continue Reading

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References

Mar 1, 2005·Oncogene·Daniel J DauerEric B Haura
Jun 10, 2006·The American Journal of Clinical Nutrition·Kenneth C FearonUNKNOWN Cancer Cachexia Study Group
Jan 25, 2007·International Journal of Colorectal Disease·Donald C McMillanColin S McArdle
Feb 3, 2007·Japanese Journal of Clinical Oncology·Kohei NakachiMasahiro Yoshino
Jul 20, 2007·Genes & Development·Brooke AncrileChristopher M Counter
Aug 2, 2007·Annals of Surgery·Karl Y BilimoriaMark S Talamonti
Sep 10, 2008·The Journal of Cell Biology·Stéphanie Kermorgant, Peter J Parker
Dec 23, 2008·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·E A EisenhauerJ Verweij
Oct 24, 2009·Nature Reviews. Cancer·Hua YuRichard Jove
Aug 18, 2010·Proceedings of the National Academy of Sciences of the United States of America·Zhan YaoRaffaella Sordella
Sep 17, 2010·The New England Journal of Medicine·Srdan VerstovsekAyalew Tefferi
Feb 2, 2011·Nature Reviews. Drug Discovery·Alfonso Quintás-CardamaSrdan Verstovsek
Mar 8, 2011·Cell·Douglas Hanahan, Robert A Weinberg
May 14, 2011·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Uwe PelzerHelmut Oettle
May 19, 2011·Cancer Research·Ryan B CorcoranNabeel Bardeesy
Jul 5, 2011·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Michael J ProctorDonald C McMillan
Nov 1, 2011·Critical Reviews in Clinical Laboratory Sciences·Kristine H Allin, Børge G Nordestgaard
Dec 6, 2011·The International Journal of Biological Markers·Yijie HanYulan Zhao
Jan 25, 2012·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Michael R GreenMargaret A Shipp
Feb 23, 2012·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Pasquale Sansone, Jacqueline Bromberg
Mar 2, 2012·The New England Journal of Medicine·Claire HarrisonGiovanni Barosi
Mar 2, 2012·The New England Journal of Medicine·Srdan VerstovsekHagop M Kantarjian
Jun 7, 2012·American Journal of Physiology. Endocrinology and Metabolism·Andrea BonettoTeresa A Zimmers
Jun 16, 2012·Cancer Cell·Yuliya Pylayeva-GuptaDafna Bar-Sagi
Jul 25, 2012·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Malabika SenJennifer R Grandis
Nov 20, 2012·Annals of Oncology : Official Journal of the European Society for Medical Oncology·T SeufferleinUNKNOWN ESMO Guidelines Working Group
Dec 5, 2012·Nature Reviews. Clinical Oncology·Kenneth FearonVickie Baracos
Jan 11, 2013·The New England Journal of Medicine·John J O'SheaLouis M Staudt
May 15, 2013·Annals of Oncology : Official Journal of the European Society for Medical Oncology·O E RahmaT F Greten

❮ Previous
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Citations

Feb 18, 2016·Acta Oncologica·Bengt Glimelius
Oct 4, 2015·Translational Research : the Journal of Laboratory and Clinical Medicine·Campbell S D Roxburgh, Donald C McMillan
Apr 2, 2016·Medicina clínica·Juan Carlos Hernández BoludaAriadna Pérez
Aug 25, 2015·Pharmacology & Therapeutics·Cindy NeuzilletPascal Hammel
Apr 5, 2016·Expert Review of Anticancer Therapy·Sana Saif Ur RehmanAndrea Wang-Gillam
Jun 28, 2016·Pharmacology & Therapeutics·Daniel DelittoSteven J Hughes
Jun 30, 2016·Expert Opinion on Therapeutic Targets·Markus JoergerSteven G Gray
Jul 28, 2016·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Tsuyoshi HamadaKazuhiko Koike
Oct 25, 2016·Gynecologic Oncology·Alma Delia Campos-ParraCarlos Pérez-Plasencia
Sep 11, 2016·Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer·Helena A YuJacqueline Bromberg
Sep 14, 2016·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Sharlene GillMalcolm Moore
Mar 11, 2017·Journal of Oncology Practice·Mingen LiuGregory L Beatty
Mar 11, 2017·Expert Opinion on Therapeutic Targets·Jennifer YangGregory B Lesinski
Apr 7, 2017·Journal of the National Cancer Institute·Angélique VienotDewi Vernerey
Jan 24, 2017·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·David R FogelmanX S Wang
Jun 26, 2017·Seminars in Cancer Biology·Jennifer HuynhMichael Buchert
May 2, 2017·Annals of Oncology : Official Journal of the European Society for Medical Oncology·J TaiebM Reni
Feb 7, 2018·Nature Reviews. Clinical Oncology·Daniel E JohnsonJennifer R Grandis
Mar 21, 2018·The Cochrane Database of Systematic Reviews·Venessa ChinDesmond Yip
Jun 24, 2017·International Journal of Molecular Sciences·Aleksandra AdamskaMarco Falasca
Jan 25, 2018·Cancers·Anuhya KommalapatiAmit Mahipal
Apr 12, 2018·Expert Opinion on Pharmacotherapy·Anem WaheedMuhammad Wasif Saif
Apr 18, 2018·Journal of Clinical Pharmacology·Daohong Chen
Aug 18, 2017·Cancer·Mohamad Bassam SonbolTanios Bekaii-Saab
Aug 16, 2017·World Journal of Gastrointestinal Oncology·Sally C Lau, Winson Y Cheung
Nov 11, 2017·Expert Review of Anticancer Therapy·Yusuf KarakasSuayib Yalcin
Dec 23, 2015·The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi·Sang Hoon Lee, Seung Woo Park
Feb 6, 2018·F1000Research·William VainchenkerStefan N Constantinescu
Dec 13, 2018·Expert Opinion on Investigational Drugs·Sreenivasa ChandanaDaruka Mahadevan
Dec 1, 2018·American Journal of Clinical Oncology·Erica S TsangHagen F Kennecke
Feb 2, 2018·Journal of Hematology & Oncology·Yiyin ZhangXianjun Yu
Mar 7, 2019·Medical Sciences : Open Access Journal·Daohong Chen
May 10, 2016·Nature Reviews. Disease Primers·Jorg KleeffJohn P Neoptolemos
May 18, 2019·Expert Opinion on Drug Metabolism & Toxicology·Btissame El HassouniElisa Giovannetti
Apr 4, 2019·American Journal of Physiology. Renal Physiology·Jesse PaceSandeep K Mallipattu
Sep 28, 2016·World Journal of Gastroenterology : WJG·Shiro Kimbara, Shunsuke Kondo
Dec 29, 2018·The Oncologist·Andrew E HendifarUNKNOWN Precision Promise Consortium
Apr 17, 2020·Physiological Reviews·Elisabeth HessmannAlbrecht Neesse
Apr 18, 2020·Experimental & Molecular Medicine·So-Yeon Park, Jeong-Seok Nam

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