Study Name
NuTIde:121
ClinicalTrials.gov Identifier (if applicable)
NCT04163900
Clinical Trial Category (check all that apply)
  • First Line Therapy
  • Chemotherapy
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/PrincessMargaret
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
+61 2 91133355

Melbourne The Alfred Hospital
+03 9076 0569

Murdoch Fiona Stanley Hospital
+61 8 6152 6715

Nedlands Sir Charles Gairdner Hospital
+61 8 6383 3180

Newcastle Newcastle Private Hospital
+61 2 4941 8718

Townsville Townsville Cancer Centre
+61744333548

Westmead Westmead Hospital
+612 8890 3725

Canada
Barrie, Ontario Royal Victoria Regional Health Centre (705) 728-9090 Ext. 43340

Calgary Tom Baker Cancer Centre
+1-403-521-3925

Halifax Nova Scotia Health Authority
+902-473-6105

Montreal CHUM Centre de Recherche
(514) 890-8000 ext23284

Montreal SMBD Jewish General Hospital d/b/a Jewish General Hospital
514.340.8222 ext. 26159

Ottawa The Ottawa Hospital Cancer Centre
+613-737-7700

Toronto Princess Margaret Cancer Centre

Toronto Sunnybrook Research Institute +41648050007868

Czech Republic
Brno Fakultni nemocnice Brno
+420 532 232 939

Hradec Kralove Fakultni nemocnice Hradec Kralove +420 495 834 648

Olomouc Fakultni nemocnice Olomouc
+420 588 443 895

Praha Thomayerova nemocnice
+00420 261 083 359

Praha Nemocnice Na Homolce
+420 257 272 829

France
Dijon cedex Centre Georges François Leclerc
+33 3 80 73 75 00

Grenoble CHU de Grenoble – Hôpital Nord
+33 04 76 76 61 50

Levallois-Perret Institut Hospitalier Franco-Britannique +0147591925

Lyon Centre Léon Bérard
+33 426556842

Paris Hôpital Cochin
+33158414271

Saint Herblain ICO – Site René Gauducheau
+33 (0)2.40.67.99.00 poste 9163

Germany
Berlin Charite Universitaetsmedizin Berlin – Campus Virchow
+49 30 450-553834

Berlin Vivantes Klinikum Neukoelln
+49 30130142240

Freiburg Universitaetsklinikum Freiburg

Hannover Medizinische Hochschule Hannover
+49 511 532-19323

Heidelberg Universitaetsklinikum Heidelberg
+49 (0)6221/56-3-9095

Tuebingen Universitaetsklinikum Tuebingen +00497071-2984457

Hungary
Budapest Del-pesti Centrumkorhaz – Orszagos Hematologiai es Infektologiai Intezet
+061/455-8280/ +36 20 2001889

Budapest Orszagos Onkologiai Intezet
+36 20 403 35 81/+36 20 932 22 86

Budapest Semmelweis Egyetem
+36 20 666 3691

Debrecen Debreceni Egyetem
+36 30 184 1232/ +36 70 354 6939

Miskolc Borsod-Abauj-Zemplen Megyei Kozponti

Korhaz es Egyetemi Oktatokorhaz
+36 70 417 2314/ +36 70 220 3393

Szolnok Jasz-Nagykun-Szolnok Megyei Hetenyi Geza

Korhaz-Rendelointezet
+36 20 4437248

Italy
Genova Ospedale Policlinico San Martino-Uo Oncologia Medica 1-Padiglione Patologie Complesse +39 0105554386

Milano IEO Istituto Europeo di Oncologia
+39 02 94372730

Napoli Istituto Nazionale Tumori Fondazione G. Pascale
+39 081 5903629

Padova IOV – Istituto Oncologico Veneto IRCCS
+39 049 821 5796

Pisa Azienda Ospedaliero Universitaria Pisana
+39 050 993841

Verona Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
+390458126564

Korea, Republic of
Guro-Gu Korea University Guro Hospital
82-2-2626-2212

Hwasun-gun Chonnam National University Hwasun Hospital
+82-61-379-7876

Pusan Dong-A University Hospital
+82-51-240-2576

Seongnam-si Seoul National University Bundang Hospital
+82-10-5659-6225

Seongnam-si, CHA Bundang Medical Center, CHA University
+82-31-780-3962

Seoul Asan Medical Center
+82-2-2045-3897

Seoul Korea University Anam Hospital
+82 2 920 6950

Seoul Samsung Medical Center
+82-10-9967-4795

Seoul Seoul National University Hospital +82260725172

Seoul Severance Hospital, Yonsei University
+82 2 2227 8279

Russian Federation
Moscow “VitaMed” LLC +79262123174

Moscow FSBSI “Russian Oncological Scientific Center n.a. N.N. Blokhin”
+7-925-884-22-23

Moscow FSBSI “Russian Oncological Scientific Center n.a. N.N. Blokhin”
+79250497217

Saint-Petersburg Pavlov First Saint Petersburg State Medical University
+7 (921) 599-00-21

Saint-Petersburg SPb SBIH “City Clinical Oncological Dispensary”
+79119720092

Saint-Petersburg State Budget Institution of Healthcare “Leningrad Regional Clinical Oncology Dispensary”
+7-981-792-83-37

Tyumen Medicinskiy gorod
+7(3452)270-517

Spain
Barcelona Hospital Clinic de Barcelona
+932275400 ext 3016

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
+34 93 489 4374

L’Hospitalet de Llobregat Edificio General – planta baja +34 93.260.70.63

Madrid Hospital General Universitario Gregorio Marañon
+34914269628

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
Changhua Changhua Christian Medical Foundation
Changhua Christian Hospital
+886 983-901751/+886-4-7238595 ext. 3933

Taichung China Medical University Hospital
+886 988278561

Taipei MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital
+886-2-2543-3535 ext 2854

Taipei National Taiwan University Hospital
+886-963-858-030/ +886 2 23123456 ext. 67853

Taipei Taipei Veterans General Hospital
+886-22871-2121ext 2999/ 886 976107317 / +886 927-751-328

Turkey
Adana Acibadem Adana Hospital
+905357996913

Adana Baskent University Adana Application and Research Center
+905365676090

Ankara Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
+90 5073616268
+903123360909

Antalya Akdeniz University Medical Faculty +905336878739

Edirne Trakya University Medical Faculty +905343667754

Istanbul Istanbul University Cerrahpasa – Cerrahpasa Medical Faculty

Malatya Inonu Uni. Med. Fac.
+905059045337

Ukraine
Chernivtsi CI Chernivtsi RC Oncological Dispensary +380505380073

Kharkiv CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection +380669341743

Kharkiv Communal Non-profit Enterprise Regional Center of Oncology, Kharkiv NMU
+380501032440

Kyiv Kyiv City Clinical Oncological Center +380506612975

Kyiv SI “Shalimov’s National Institute of Surgery and Transplantation” of NAMSU
+38 093 972-05-96

Lutsk Treatment-Prevention Institution Volyn Regional Oncological Dispensary
+380332260769

Odesa Communal Institution Odesa Regional Clinical Hospital
+380979805196

Sumy RCI Sumy Regional Clinical Oncological Dispensary
+380542781306

United Kingdom
Edinburgh Western General Hospital
+0131 537 2202

Glasgow Beatson West of Scotland Cancer Centre +44 (0) 141 301 7791

London Guy’s Hospital
+44 20 7188 1466

Manchester The Christie
+44 (0) 161 446 3439

Torquay Torbay Hospital
+01803 656621

Wirral The Clatterbridge Cancer Centre
+0151 556 5510/5527

United States
Aurora Rocky Mountain Cancer Centers, LLP- Aurora +(303)418-7639

Austin Texas Oncology, P.A. – Austin
+(512)421-4100

Boston Beth Israel Deaconess Medical Center
+(617) 975-7459

Boston Massachusetts General Hospital
+617-643-5411

Chicago Ridge Affiliated Oncologists LLC
+(708)424-9710

Columbus IACT Health
+7066606449

Columbus Ohio State University Clinical Trials Management Office
+614-685-5224

Dallas Baylor Charles A. Sammons Cancer Center
+(214)370-1000

Detroit Henry Ford Medical Group
+3139161827

El Segundo UC Irvine Medical Center
+310-486-8668

Greenville Prisma Health Upstate
+864-241-6251

Houston Millennium Oncology
+(877) 870-2640

Louisville Norton Cancer Institute
+502-636-7845

Lubbock Joe Arrington Cancer Research Treatment Center
+8067258075

Milwaukee The Medical College of Wisconsin, Inc.
+(414) 805-4639

Minneapolis Minnesota Oncology Hematology, P.A. +(612) 84-6300

Minneapolis Regents of the University of Minnesota +612-626-8448

Orlando Orlando Health, Inc.
+321-841-8284

Philadelphia Corporal Michael J. Crescenz VA
Medical Center
+215-823-5800 Ext:2585

Rochester University of Rochester Medical Center – Strong Memorial Hospital
+(585) 275-2224

Stony Brook The Research Foundation for The State University of New York
+ (631) 216-2974

Tucson Arizona Oncology Associates , PC – HOPE +5208860206

Tuscon University of Arizona Cancer Center
+(520) 694-9065

Tyler Texas Oncology, P.A. – Tyler
+(903) 757-2122

Vancouver Northwest Cancer Specialists, P.C.-Vancouver
+(360)449-6521

Washington Virginia Mason Medical Center
+1 (206) 287-6272

Wenatchee Wenatchee Valley Hospital & Clinics
+(617) 975-7459

Westwood University of Kansas Medical Center Research Institute, Inc.
+913-588-6939

Whittier The Oncology Institute of Hope and Innovation
+5626934477

Winston-Salem Wake Forest University Health Sciences +(336)713-6914

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.gov.au

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@huntervalleyoncology.com.au

Varma, Suresh suresh.varma@health.qld.gov.au

Wong, Mark mark.wong@sydney.edu.au

Canada
Ng, Dawn ngd@rvh.on.ca

Tam, Vincent vincent.tam@albertahealthservices.ca

Ramjeesingh, Ravi ravi.ramjeesingh@nshealth.ca

Letourneau Richard richard.letourneau.chum@ssss.gouv.qc.ca

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
Kral, Zdenek kral.zdenek@fnbrno.cz

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
Ghiringhelli, Francois fghiringhelli@cgfl.fr

Roth, Gael groth@chu-grenoble.fr

De Gramont, Aimery aimerydegramont@gmail.com

Rochefort, Pauline pauline.rochefort@lyon.unicancer.fr

Coriat, Romain romain.coriat@aphp.fr

Raoul, Jean-Luc jean-luc.raoul@ico.unicancer.fr

Germany
Pelzer, Uwe uwe.pelzer@charite.de

de Wit, Maike maike.dewit@vivantes.de

Becker, Heiko heiko.becker@uniklinik-freiburg.de

Vogel, Arndt vogel.arndt@mh-hannover.de

Springfeld, Christoph christoph.springfeld@med.uni-heidelberg.de

Bitzer, Michael michael.bitzer@uni-tuebingen.de

Hungary
Bodoky, Gyorgy bodokygy@hungarnet.hu

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
Sobrero, Alberto alberto.sobrero@hsanmartino.it

Fazio, Nicola nicola.fazio@ieo.it

Avallone, Antonio a.avallone@istitutotumori.na.it

Lonardi, Sara sara.lonardi@iov.veneto.it

Fornaro, Lorenzo lorenzo.fornaro@gmail.com

Melisi, Davide davide.melisi@gmail.com

Korea, Republic of
Oh, Sang Cheul sachoh@korea.ac.kr

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
Poddubskaya, Elena podd-elena@yandex.ru

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
Sauri Nadal, Tamara sauri@clinic.cat

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@hotmail.com

Reina Zoilo, Juan Jose juanjoreinaz@yahoo.es

Taiwan
Wang, Chuan-Cheng 114992@cch.org.tw

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
Disel, Umut doctorhope@gmail.com

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
Semehen, Yuriy yuriysemegen@i.ua

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
Christie, Alan alan.christie@nhslothian.scot.nhs.uk

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
Nallapareddy, Sujatha sujatha.nallapareddy@usoncology.com

Cline-Burkhardt, Vivian mika.cline-burkhardt@usoncology.com

Peters, Mary mbpeters@bidmc.harvard.edu

Goyal,Lipika lgoyal@partners.org

Haddad, Rami rami.haddad@vantageoncology.com

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@nortonhealthcare.org

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@stonybrookmedicine.edu

Manda, Sudhir sudhir.manda@usoncology.com

Shroff, Rachna rshroff@email.arizona.edu

Richards, Donald donald.richards@usoncology.com

Cosgrove, David david.cosgrove@compassoncology.com

Lin, Shih-Li bruce.lin@vmmc.org

Overton, Lindsay rr-overton@confluencehealth.org

Al-Rajabi, Raed ral-rajabi@kumc.edu

Shum, Merrill mshum@airesearch.us

Rocha-Lima, Caio Max crochali@wakehealth.edu

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
Lakshmi.Sharma-Diwakarla@health.wa.gov.au

Jolanta Damas Jolanta.Damas1@health.wa.gov.au

Julie Charlton julie.charlton@healthscope.com.au

Judith Page judith.page@health.qld.gov.au

Hanieh Fattahi Hanieh.fattahi@health.nsw.gov.au

Canada
Crawford,Melanie crawfordme@rvh.on.ca

Salim Ahmed Salim.ahmed@ahs.ca

Lorrie Yunace lorrie.yunace@nshealth.ca

Ghislaine Ahoua ghislaine.ahoua.chum@ssss.gouv.qc.ca

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
Zuzana Cernocka/ Katarina Kurakova cernocka.zuzana@fnbrno.cz

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
Francois GHIRINGHELLI fghiringhelli@cgfl.fr

Laure BORDY lbordy@chu-grenoble.fr

BELKHIR kahina.belkhir-hadid@ihfb.org

Pauline Linard pauline.linard@lyon.unicancer.fr

Nadira Kaddour Nadira.kaddour@aphp.fr

Jérémy DAVY jeremy.davy@ico.unicancer.fr

Germany
Susanne Grüneberg susanne.grueneberg@charite.de

Dorothee Scholz dorothee.scholz@vivantes.de

Irina Surlan. irina.surlan@uniklinik-freiburg.de
Beate.Wirth@uniklinik-freiburg.de

Nadine Güldenstein
gueldenstein.nadine@mh-hannover.de

Margit Peters-Hornig margit.peters-hornig@med.uni-heidelberg.de

Ursula Koppenhöfer ursula.koppenhoefer@med.uni-tuebingen.de

Hungary
Vivien Garajszki/ Tóth Erika garajszki.vivien@dpckorhaz.hu/crohungary@gmail.com

Burjan Timea /Balogh Brigitta timea.burjan@coordination.hu/Brigitta.balogh@coordination.hu

Mészáros Brigitta trial.sote@gmail.com

Ildiko Jakab/Krisztina Bacsine Varga ildiko_jakab@freemail.hu/bacsine.varga.krisztina@gmail.com

Szilvia Ligay/Krisztina Campean coordinator@bazmkorhaz.h/campean@freemail.hu

Edina Bodor edina.bodor11@gmail.com

Italy
Carla Curti carla.curti@hsanmartino.it

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
Minji Jo suee2na@naver.com

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
Natalia Yakovleva nat695@yandex.ru

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
Spain
ACHAERANDIO@clinic.cat

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
Chin-Feng Chung 25390@cch.org.tw

Jui-Chuan Chin jcc.a081@mmh.org.tw

116217@ntuh.gov.tw

micky198725@gmail.com/ leeyh@ntuh.gov.tw

Ling-Ling Chiu
chiu458151@gmail.com

Turkey
Mediha Avci mediha.avci@acibadem.com.tr

Seyma BLIR seyma.bilir@atlascro.com.tr

Elçin Demirkol
Elcin.demirkol@medismart.com.tr

Dudu Uysal dudu.uysal@medismart.com.tr

Tugce Buket Guler buket.guler@atlascro.com.tr

Refah Karatas refahkaratas@hotmail.com

Ukraine
Tashchuk Illya il_taschuk@yahoo.com

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
Arielle Wilson-Dodard Arielle.wilson-dodard@ed.ac.uk

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
Boynton, Lynne F ipcprojectmanagement@mckesson.com

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@usoncology.com/ ipcprojectmanagement@mckesson.com

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@nortonhealthcare.org

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@orlandohealth.com

Muhammad Zahid muhammad.zahid@va.gov

Jessica E. Mackowiak Jessica_Ellis@urmc.rochester.edu

Cara Fidnarick Cara.Fidnarick@stonybrookmedicine.edu

Stacey Kimbell stacey.kimbell@usoncology.com

Pennington,Daniel danielpennington@email.arizona.edu

Shelly Maxfield shelly.maxfield@usoncology.com

Zandra E McChesney zandra.mcchesney@usoncology.com/ ipcprojectmanagement@mckesson.com

Daniel J. Dudley Daniel.Dudley@virginiamason.org

Diane M. Davis
Patty Garland Diane.davis2@confluencehealth.org
patricia.garland@confluencehealth.org

Benjamin Roberts broberts4@kumc.edu

Susan Tieng stieng@icrinstitute.com

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
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)
  • To test the anti-cancer activity of NUC-1031 when given in combination with cisplatin in people with biliary tract cancer
  • To compare NUC-1031 with the standard treatment of gemcitabine in combination with cisplatin in people with biliary tract cancer
  • To explore the safety of the study treatments and the impact they have on your quality of life.
Inclusion Criteria – Patients Must:
  • Female or male patients ≥18 years of age
  • Histologically-or cytologically- confirmed adenocarcinoma of the biliary tract (intra and extra-hepatic cholangiocarcinoma, gallbladder, or ampullary cancers) that is locally advanced, unresectable or metastatic
  • Life expectancy ≥16 weeks
  • ECOG performance status 0 or 1
  • Adequate biliary drainage with no evidence of ongoing infection
Exclusion Criteria – Patients Must NOT:
  • Combined or mixed hepatocellular/ cholangiocarcinoma
  • Prior treatment for advanced or metastatic disease
  • Known hypersensitivity to NUC-1031, gemcitabine, cisplatin or other platinum-based agents
  • Known central nervous system metastases
  • History of other malignancies
  • Ongoing or recent hepatorenal syndrome
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • Screening is designed to check this is a suitable study for you to take part in. Screening can take up to 21 days and may involve separate visits for clinic assessments and scans. During or at the end of this screening phase, it may be determined that you are not eligible to continue into the study. If so, your study doctor will inform you and will make plans with you for appropriate alternative treatment for your disease. If you are eligible and you decide to participate in the study, you will return to visit the study doctor and be treated with study drug on the first day, known as Cycle 1 Day 1.
  • General health check (including medical history, prior cancer treatment, and symptoms)
  • Physical examination
  • Vital signs, height, weight
  • Eastern Cooperative Oncology Group (ECOG) performance status
  • Electrocardiogram
  • Pregnancy test (if applicable)
  • Blood sample to check organ function
  • Blood sample to check clotting profile
  • Questionnaires
  • Cancer measurement scan
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • Decreased blood cell counts
  • Low level of magnesium in the blood
  • Low level of albumin in the blood
  • Low level of potassium in the blood
  • low level of phosphorous in the blood
  • Increased liver function enzymes (enzymes called ALT, AST and ALP can be increased in the blood when the liver is damaged)
  • Tiredness
  • Fever (high body temperature)
  • Lung Infection
  • Cellulitis (skin Infection)
  • Thrombus (blood clots)
  • Dyspnoea (shortness of breath)
  • Peripheral Oedema (accumulation of fluid causing swelling in the arms and legs)
  • Gastrointestinal disturbances