NuTIde:121
| Study Name | |
| NuTIde:121 | |
| ClinicalTrials.gov Identifier (if applicable) | |
| NCT04163900 | |
| Clinical Trial Category (check all that apply) | |
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| Study Center | |
| Institution Name | |
| Princess Margaret Cancer Centre | |
| Institution Address | |
| 610 University Ave | |
| City | |
| Toronto | |
| State | |
| – Please Select – | |
| Zip Code | |
| M5G 2C1 | |
| Country | |
| Canada | |
| Phone | |
| (416) 581-7603 | |
| Website | |
| https://www.uhn.ca/ |
|
| List additional Institutions (include address, phone number, and website) | |
| Australia Camperdown Chris O’Brien Lifehouse +61 2 8514 0378. Heidelberg Day Oncology, Warringal Private Hospital +0392741423 Kogarah St George Hospital Melbourne The Alfred Hospital Murdoch Fiona Stanley Hospital Nedlands Sir Charles Gairdner Hospital Newcastle Newcastle Private Hospital Townsville Townsville Cancer Centre Westmead Westmead Hospital Canada Calgary Tom Baker Cancer Centre Halifax Nova Scotia Health Authority Montreal CHUM Centre de Recherche Montreal SMBD Jewish General Hospital d/b/a Jewish General Hospital Ottawa The Ottawa Hospital Cancer Centre Toronto Princess Margaret Cancer Centre Toronto Sunnybrook Research Institute +41648050007868 Czech Republic Hradec Kralove Fakultni nemocnice Hradec Kralove +420 495 834 648 Olomouc Fakultni nemocnice Olomouc Praha Thomayerova nemocnice Praha Nemocnice Na Homolce France Grenoble CHU de Grenoble – Hôpital Nord Levallois-Perret Institut Hospitalier Franco-Britannique +0147591925 Lyon Centre Léon Bérard Paris Hôpital Cochin Saint Herblain ICO – Site René Gauducheau Germany Berlin Vivantes Klinikum Neukoelln Freiburg Universitaetsklinikum Freiburg Hannover Medizinische Hochschule Hannover Heidelberg Universitaetsklinikum Heidelberg Tuebingen Universitaetsklinikum Tuebingen +00497071-2984457 Hungary Budapest Orszagos Onkologiai Intezet Budapest Semmelweis Egyetem Debrecen Debreceni Egyetem Miskolc Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz Szolnok Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet Italy Milano IEO Istituto Europeo di Oncologia Napoli Istituto Nazionale Tumori Fondazione G. Pascale Padova IOV – Istituto Oncologico Veneto IRCCS Pisa Azienda Ospedaliero Universitaria Pisana Verona Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) Korea, Republic of Hwasun-gun Chonnam National University Hwasun Hospital Pusan Dong-A University Hospital Seongnam-si Seoul National University Bundang Hospital Seongnam-si, CHA Bundang Medical Center, CHA University Seoul Asan Medical Center Seoul Korea University Anam Hospital Seoul Samsung Medical Center Seoul Seoul National University Hospital +82260725172 Seoul Severance Hospital, Yonsei University Russian Federation Moscow FSBSI “Russian Oncological Scientific Center n.a. N.N. Blokhin” Moscow FSBSI “Russian Oncological Scientific Center n.a. N.N. Blokhin” Saint-Petersburg Pavlov First Saint Petersburg State Medical University Saint-Petersburg SPb SBIH “City Clinical Oncological Dispensary” Saint-Petersburg State Budget Institution of Healthcare “Leningrad Regional Clinical Oncology Dispensary” Tyumen Medicinskiy gorod Spain Barcelona Hospital de la Santa Creu i Sant Pau +935565585 Barcelona Servei Oncología Edificio General – planta baja Hospital Vall d’Hebron Pg Vall D’hebron L’Hospitalet de Llobregat Edificio General – planta baja +34 93.260.70.63 Madrid Hospital General Universitario Gregorio Marañon Madrid Hospital Universitario Clinico San Carlos +003413303541 / ‘+0034913303000 ext 7545, 7526 Madrid Hospital Universitario HM Madrid Sanchinarro +34917567984 Sevilla Hospital Universitario Virgen del Rocio +34955013068 Sevilla Hospital Universitario Virgen Macarena +697958425 Taiwan, Republic of China Taichung China Medical University Hospital Taipei MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital Taipei National Taiwan University Hospital Taipei Taipei Veterans General Hospital Turkey Adana Baskent University Adana Application and Research Center Ankara Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital Antalya Akdeniz University Medical Faculty +905336878739 Edirne Trakya University Medical Faculty +905343667754 Istanbul Istanbul University Cerrahpasa – Cerrahpasa Medical Faculty Malatya Inonu Uni. Med. Fac. Ukraine Kharkiv CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection +380669341743 Kharkiv Communal Non-profit Enterprise Regional Center of Oncology, Kharkiv NMU Kyiv Kyiv City Clinical Oncological Center +380506612975 Kyiv SI “Shalimov’s National Institute of Surgery and Transplantation” of NAMSU Lutsk Treatment-Prevention Institution Volyn Regional Oncological Dispensary Odesa Communal Institution Odesa Regional Clinical Hospital Sumy RCI Sumy Regional Clinical Oncological Dispensary United Kingdom Glasgow Beatson West of Scotland Cancer Centre +44 (0) 141 301 7791 London Guy’s Hospital Manchester The Christie Torquay Torbay Hospital Wirral The Clatterbridge Cancer Centre United States Austin Texas Oncology, P.A. – Austin Boston Beth Israel Deaconess Medical Center Boston Massachusetts General Hospital Chicago Ridge Affiliated Oncologists LLC Columbus IACT Health Columbus Ohio State University Clinical Trials Management Office Dallas Baylor Charles A. Sammons Cancer Center Detroit Henry Ford Medical Group El Segundo UC Irvine Medical Center Greenville Prisma Health Upstate Houston Millennium Oncology Louisville Norton Cancer Institute Lubbock Joe Arrington Cancer Research Treatment Center Milwaukee The Medical College of Wisconsin, Inc. Minneapolis Minnesota Oncology Hematology, P.A. +(612) 84-6300 Minneapolis Regents of the University of Minnesota +612-626-8448 Orlando Orlando Health, Inc. Philadelphia Corporal Michael J. Crescenz VA Rochester University of Rochester Medical Center – Strong Memorial Hospital Stony Brook The Research Foundation for The State University of New York Tucson Arizona Oncology Associates , PC – HOPE +5208860206 Tuscon University of Arizona Cancer Center Tyler Texas Oncology, P.A. – Tyler Vancouver Northwest Cancer Specialists, P.C.-Vancouver Washington Virginia Mason Medical Center Wenatchee Wenatchee Valley Hospital & Clinics Westwood University of Kansas Medical Center Research Institute, Inc. Whittier The Oncology Institute of Hope and Innovation Winston-Salem Wake Forest University Health Sciences +(336)713-6914 |
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| Study Contacts | |
| Principal Investigator | |
| Dr Jennifer Knox | |
| P.I. Phone | |
| (416) 946-2399 | |
| P.I. Email | |
| Jennifer.Knox@uhn.ca | |
| List additional Principal Investigators (include phone number and email) | |
| Australia Sim, Hao-Wen haowen.sim@lh.org.au Tebbutt,Niall niall.tebbutt@onjcri.org.au Sjoquist, Katrin Katrin.Sjoquist@health.nsw. Zalcberg, John john.zalcberg@monash.edu Ransom, David david.ransom@health.wa.gov.au Jasas, Kevin kevin.jasas@health.wa.gov.au Paterson, Robin robpaterson@ Varma, Suresh suresh.varma@health.qld.gov.au Wong, Mark mark.wong@sydney.edu.au Canada Tam, Vincent vincent.tam@ Ramjeesingh, Ravi ravi.ramjeesingh@nshealth.ca Letourneau Richard richard.letourneau.chum@ssss. Kavan, Petr petr.kavan@mcgill.ca Bossé, Dominick Dbosse@toh.ca Knox, Jennifer jennifer.knox@uhn.ca Raphael, Michael michaelj.raphael@sunnybrook.ca Czech Republic John, Stanislav stanislav.john@fnhk.cz Melichar, Bohuslav bohuslav.melichar@fnol.cz Zitnanska, Lucie lucie.zitnanska@ftn.cz Safanda, Martin martin.safanda@homolka.cz France Roth, Gael groth@chu-grenoble.fr De Gramont, Aimery aimerydegramont@gmail.com Rochefort, Pauline pauline.rochefort@lyon. Coriat, Romain romain.coriat@aphp.fr Raoul, Jean-Luc jean-luc.raoul@ico.unicancer. Germany de Wit, Maike maike.dewit@vivantes.de Becker, Heiko heiko.becker@uniklinik- Vogel, Arndt vogel.arndt@mh-hannover.de Springfeld, Christoph christoph.springfeld@med.uni- Bitzer, Michael michael.bitzer@uni-tuebingen. Hungary Hitre, Erika hitre@oncol.hu Dank, Magdolna dank.oncology@gmail.com Arkosy, Peter arkosy.peter@med.unideb.hu Revesz, Janos dr.revesz.janos@gmail.com Csoszi, Tibor dr.cstibor@freemail.hu Italy Fazio, Nicola nicola.fazio@ieo.it Avallone, Antonio a.avallone@istitutotumori.na. Lonardi, Sara sara.lonardi@iov.veneto.it Fornaro, Lorenzo lorenzo.fornaro@gmail.com Melisi, Davide davide.melisi@gmail.com Korea, Republic of Hwang, Jun Eul hjunyl@naver.com Oh, Sung Yong drosy@dau.ac.kr Kim, Jin Won whunt@daum.net Chon, Hongjae minidoctor@cha.ac.kr Yoo, Changhoon changhoon.yoo.amc@gmail.com Kim, Yeul Hong yhk0215@korea.ac.kr Park, Joon Oh oncopark@skku.edu Oh, Do-Youn ohdoyoun@snu.ac.kr Lee, Choong-kun cklee512@yuhs.ac Russian Federation Bazin, Igor bazin_onk@mail.ru Breder, Valery vbreder@yandex.ru Orlov, Sergey V orloff-sv@mail.ru Orlova, Rashida orlova_rashida@mail.ru Smagina, Maria smaginamaria@mail.ru Frank, Eugeny xo.medcity@gmail.com Spain Martin-Richard, Marta mmartinri@santpau.cat Verdaguer Mata, Helena hverdaguer@vhio.net Laquente Saez, Berta blaquente@iconcologia.net Muñoz Martin, Andres andresmunmar@hotmail.com Sastre Valera, Javier jsastrev@salud.madrid.org Cubillo Gracian, Antonio. acubillo@hmhospitales.com Sanchez Simon, Inmaculada inmaculadasanchezsimon@ Reina Zoilo, Juan Jose juanjoreinaz@yahoo.es Taiwan Bai, Li-Yuan lybai6@gmail.com Su, Ying-Wen yingwensu@gmail.com Hsu, Chih-Hung chihhunghsu@ntu.edu.tw Chen, Ming-Huang mhchen9@gmail.com Turkey Sezer, Ahmet drasezer@hotmail.com.tr Oksuzoglu, Berna doktorbernao@gmail.com Coskun, Hasan Senol hs.coskun@yahoo.com Erdogan, Bulent berdoga@hotmail.com Ozguroglu, Mustafa ozguroglu@gmail.com Harputluoglu, Hakan harputlu@hotmail.com Ukraine Neffa, Maryna marina.neffa@meta.ua Skoryi, Denys denys.skoryi@gmail.com Osynskyi, Dmytro dosinsky@ukr.net Zubkov, Oleksii zubkov.snist@gmail.com Sinielnikov, Ivan ivan.sinielnikov@gmail.com Zaychuk, Anatoliy aabigol@gmail.com Vynnychenko, Ihor vynnych@gmail.com United Kingdom Braconi, Chiara chiara.braconi@glasgow.ac.uk Ross, Paul paul.ross@gstt.nhs.uk Valle, Juan juan.valle@christie.nhs.uk Rees, Charlotte louise.medley@nhs.net Palmer, Daniel daniel.palmer@liverpool.ac.uk United States Cline-Burkhardt, Vivian mika.cline-burkhardt@ Peters, Mary mbpeters@bidmc.harvard.edu Goyal,Lipika lgoyal@partners.org Haddad, Rami rami.haddad@vantageoncology. Pippas, Andrew apippas@iacthealth.com Abushahin, Laith laith.abushahin@osumc.edu Paulson, Andrew scott.paulson@usoncology.com Khan, Gazala gkhan1@hfhs.org Seery, Tara tara.seery@cssifm.org Chung, Ki ki.chung@prismahealth.org Dasgupta, Anirudha adasgupta@wmrad.com Driscoll, Michael Michael.Driscoll@ Yalamanchili, Kiran yalkik@covhs.org Shreenivas, Aditya ashreenivas@mcw.edu Larson, Timothy tim.larson@usoncology.com Greeno, Edward green048@umn.edu Kayaleh, Omar omar.kayaleh@orlandohealth.com Damjanov, Nevena nevena.damjanov@va.gov Hezel, Aram aram_hezel@urmc.rochester.edu Choi, Minsig minsig.choi@ Manda, Sudhir sudhir.manda@usoncology.com Shroff, Rachna rshroff@email.arizona.edu Richards, Donald donald.richards@usoncology.com Cosgrove, David david.cosgrove@ Lin, Shih-Li bruce.lin@vmmc.org Overton, Lindsay rr-overton@confluencehealth. Al-Rajabi, Raed ral-rajabi@kumc.edu Shum, Merrill mshum@airesearch.us Rocha-Lima, Caio Max crochali@wakehealth.edu |
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| Study Coordinator | |
| Natalia Ramnarine | |
| Study Coordinator Phone | |
| (416) 581-7603 | |
| Study Coordinator Email | |
| Natalia.Ramnarine@uhn.ca | |
| List additional Study Coordinators (include phone number and email) | |
| Australia Masako Dunn Masako.Dunn@lh.org.au Guo Yuan GuoYuan@ramsayhealth.com.au Lisa Wang Lisa.Wang@health.nsw.gov.au Kate Sinn k.sinn@alfred.org.au Sharma-Diwakarla, Lakshmi Jolanta Damas Jolanta.Damas1@health.wa.gov. Julie Charlton julie.charlton@healthscope. Judith Page judith.page@health.qld.gov.au Hanieh Fattahi Hanieh.fattahi@health.nsw.gov. Canada Salim Ahmed Salim.ahmed@ahs.ca Lorrie Yunace lorrie.yunace@nshealth.ca Ghislaine Ahoua ghislaine.ahoua.chum@ssss. Cecilia Rodriguez cecilia.rodriguez@ladydavis.ca Caryn Bohemier cbohemier@toh.ca Natalia Ramnarine Natalia.Ramnarine@uhn.ca Kate Besel kate.besel@sunnybrook.ca Czech Republic Klara Reznickova klara.reznickova@fnhk.cz Magda Simkova magda.simkova@fnol.cz Jaroslava Skálová jaroslava.skalova@ftn.cz Eva BURGERSTEINOVÁ eva.burgersteinova@homolka.cz France Laure BORDY lbordy@chu-grenoble.fr BELKHIR kahina.belkhir-hadid@ihfb.org Pauline Linard pauline.linard@lyon.unicancer. Nadira Kaddour Nadira.kaddour@aphp.fr Jérémy DAVY jeremy.davy@ico.unicancer.fr Germany Dorothee Scholz dorothee.scholz@vivantes.de Irina Surlan. irina.surlan@uniklinik- Nadine Güldenstein Margit Peters-Hornig margit.peters-hornig@med.uni- Ursula Koppenhöfer ursula.koppenhoefer@med.uni- Hungary Burjan Timea /Balogh Brigitta timea.burjan@coordination.hu/ Mészáros Brigitta trial.sote@gmail.com Ildiko Jakab/Krisztina Bacsine Varga ildiko_jakab@freemail.hu/ Szilvia Ligay/Krisztina Campean coordinator@bazmkorhaz.h/campe Edina Bodor edina.bodor11@gmail.com Italy Sabrina Boselli sabrina.boselli@ieo.it Maria Bruno m.bruno@istututotumori.na.it simona pavan simona.pavan@iov.veneto.it matteo franceschi matteo.franceschi.90@gmail.com Irene Rossi Irene.Rossi@crc.vr.it Republic of Korea Kuk Hwa Yang yangkh1004@naver.com Ha Ju Heon dongahicrc9@naver.com Seohee Seong R2661@snubh.org Ah Reum Moon mmreum1@gmail.com Da Hee Park dhpark38@amc.seoul.kr Eun Ju Han magiclan47@naver.com Ah Reum Oh ahreum107.oh@samsung.com Hye Won Han snuh_hw@naver.com Yun Ji Heo dmonco18@yuhs.ac Russian Federation Nadezhda MESHCHERYAKOVA mdnadya@gmail.com Sinitsyna Olesya ole2214@yandex.ru Maria Sviridenko maria_sviridenko@list.ru Natalia Zhukova natalia-zhukova@yandex.ru Andrey Chicherin chicherin.ap1@gmail.com Natalia Yadrishnikova yadryshnikova87@inbox.ru Mercè Garcia mgarcia@santpau.cat Marta Beltran mbeltran@vhio.net Cristina Iglesias Miguez ciglesias@iconcologia.net Marta Perez mperez.hgugm@gmail.com Ines Cardenas ines.clinico@gmail.com Patricia Gomez Crespo pgomezcrespo@hmhospitales.com Rocio Roncel rocioroncel.ensayos@gmail.com Monica Suengas MTZ De Ilarduya oncomacarena@gmail.com Taiwan Jui-Chuan Chin jcc.a081@mmh.org.tw micky198725@gmail.com/ leeyh@ntuh.gov.tw” Ling-Ling Chiu Turkey Seyma BLIR seyma.bilir@atlascro.com.tr Elçin Demirkol Dudu Uysal dudu.uysal@medismart.com.tr Tugce Buket Guler buket.guler@atlascro.com.tr Refah Karatas refahkaratas@hotmail.com Ukraine Yuliia Zekun yul.zekun@gmail.com Kateryna Bukhtieieva 1kateryna.m@gmail.com Tetyana Tymchuk marchuk.vf@gmail.com Oleksii Zubkov Oleksii Zubkov|hpbsurgery.ua@gmail.com Serhii Kylynych sergiy.kilinich@gmail.com Alla Goloborodko allagol@gmail.com Anna Skrypnyk g_skrypnyk@ukr.net United Kingdom Paul Mooney Paul.Mooney@Glasgow.ac.uk Susie Slater GIResearchTeam@gstt.nhs.uk/ susie.slater@gstt.nhs.uk Michael Breeze Michael.Breeze@christie.nhs.uk Kenneth Almedilla k.almedilla@nhs.net Joanne Bygroves joanne.bygroves@nhs.net United States Michelle L Owens michelle.owens@usoncology.com Robert Besaw rbesaw@bidmc.harvard.edu Ashley O’Meara alomeara@mgh.harvard.edu Amy Brich amy.brich@usoncology.com Grayson Scott gscott@iacthealth.com Danielle Trunzo Danielle.Trunzo@osumc.edu Jonathan B Huntzinger jonathan.huntzinger@ John Gaggin JGAGGIN1@hfhs.org Jessica Daly Jessica.daly@cssifm.org Sue Dean susan.dean@prismahealth.org John R. Waldron JWaldron@wmrad.com Beth Johnson (Audubon) and Erica Widener (Brownsboro) GI-NCIResearch@ Lupe Madrid lmadrid@covhs.org Barbara Dion badion@mcw.edu Sam Greenwald Sam.Greenwald@usoncology.com Jessica Hellmer jessi013@umn.edu Ma Theresa De Leon MaTheresa.DeLeon@ Muhammad Zahid muhammad.zahid@va.gov Jessica E. Mackowiak Jessica_Ellis@urmc.rochester. Cara Fidnarick Cara.Fidnarick@ Stacey Kimbell stacey.kimbell@usoncology.com Pennington,Daniel danielpennington@email. Shelly Maxfield shelly.maxfield@usoncology.com Zandra E McChesney zandra.mcchesney@usoncology. Daniel J. Dudley Daniel.Dudley@virginiamason. Diane M. Davis Benjamin Roberts broberts4@kumc.edu Susan Tieng stieng@icrinstitute.com |
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| OVERVIEW – in layman’s terms (150 words max) | |
| NUC-1031, a new type of chemotherapy drug (called a ProTide) kills cancer cells by preventing DNA replication, similar to gemcitabine. There are several cancer resistance mechanisms known to limit the effectiveness of gemcitabine. NUC-1031 has been specifically designed to overcome these. Patients will be randomised into NUC-1031 arm or SOC arm |
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| Enrollment | |
| 828 | |
| Study Start Date | |
| 01/01/2020 | |
| Estimated Completion Date | |
| 01/01/2022 | |
| Purpose of the Study – in Layman’s Terms (use the “+” to add more list items) | |
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| Inclusion Criteria – Patients Must: | |
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| Exclusion Criteria – Patients Must NOT: | |
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| REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms | |
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| POTENTIAL SIDE-EFFECTS – in layman’s terms | |
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