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BRIEF TITLE: Trial of Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations (PROOF 302)

Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations (PROOF 302)


  • Org Study ID: QBGJ398-302
  • Secondary ID: 2019-003248-63
  • NCT ID: NCT04197986
  • NCT Alias:
  • Sponsor: QED Therapeutics, Inc. - Industry
  • Source: QED Therapeutics, Inc.

Brief Summary

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of giving an oral targeted FGFR1-3 inhibitor, infigratinib, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or translocations [ie, rearrangements) who have disease that is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy and/or nephrectomy. Study treatment is randomized between infigratinib or placebo with treatment until invasive local or distal disease recurrence.

Overal Status Start Date Phase Study Type
Recruiting March 11, 2020 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Centrally determine disease-free survival (DFS)

Primary Outcome 1 - Time Frame: Randomization through 1 year after end of treatment

Condition:

  • Upper Tract Urothelial Carcinomas
  • Urothelial Bladder Cancer

Eligibility

Criteria:
Inclusion Criteria

1. Have histologically or cytologically confirmed, invasive urothelial carcinoma with
susceptible FGFR3 alterations within 120 days following nephroureterectomy, distal
ureterectomy, or cystectomy

2. If the patient received neoadjuvant chemotherapy, pathologic stage at surgical
resection must be AJCC Stage ≥ ypT2 and/or yN+.

3. If the patient did not receive neoadjuvant chemotherapy:

1. Must be ineligible to receive cisplatin-based adjuvant chemotherapy per the
Galsky criteria:

- creatinine clearance < 60cc/min or

- ≥ Grade 2 hearing loss or

- ≥ Grade 2 neuropathy)

2. Pathologic stage must be AJCC Stage ≥pT2 pN0-2 M0 (post-lymphadenectomy or no
lymphadenectomy [pNx]) for upper tract disease.

3. Pathologic stage should be AJCC Stage ≥pT3 or pN+ (bladder cancer).

4. Have Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.

5. Patients must have no evidence of metastatic disease based on screening CT or MRI.

Exclusion Criteria:

1. Presence of positive surgical margins following nephroureterectomy, distal
ureterectomy, or cystectomy.

2. Have received Bacillus Calmette-Guerin (BCG) or other intravesical therapy for
Non-Muscle Invasive Bladder Cancer (NMIBC) within the previous 30 days.

3. Have previously or currently is receiving treatment with a mitogen-activated protein
kinase (MEK) or selective FGFR inhibitor.

4. Have impaired gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of oral infigratinib (eg, active ulcerative diseases,
uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel
resection)

5. Have current evidence of corneal or retinal disorder/keratopathy.

6. Have a history and/or current evidence of extensive tissue calcification.

7. Have current evidence of endocrine alterations of calcium/phosphate homeostasis (eg,
parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis),
unless well controlled.

8. Are currently receiving or are planning to receive during participation in this study,
treatment with agents that are known strong inducers or inhibitors of CYP3A4 and
medications which increase serum phosphorus and/or calcium concentration.

9. Clinically significant cardiac disease.

10. Recent (< 3 months prior to first dose of study drug) transient ischemic attack or
stroke.
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Corina Andresen, MD

Role: Study Director

Affiliation: QED Therapeutics

Overall Contact

Name: QED Therapeutics

Phone: 1-877-280-5655

Email: Proof302.ct@qedtx.com

Locations

Facility Status Contact
The University of Alabama at Birmingham
Birmingham, Alabama 35233
United States
Recruiting
Arizona Oncology Associates
Tucson, Arizona 85711
United States
Recruiting Stacey Kimbell
520-668-5678
stacey.kimbell@usoncology.com
City of Hope
Duarte, California 91010
United States
Recruiting Sumanta Pal, M.D.
626-256-4673
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Recruiting Cheryl Kefauver
323-865-3000
daneshma@usc.edu
QED Investigative Site
Sacramento, California 95817
United States
Recruiting
University of Colorado Cancer Center
Aurora, Colorado 80045
United States
Recruiting
Rocky Mountain Cancer Center
Colorado Springs, Colorado 80907
United States
Recruiting
The Urology Center of Colorado
Denver, Colorado 80211
United States
Recruiting Lawrence Karsh
303-433-4776
lkarsh@tucc.com
Georgetown University Medical Center
Washington, District of Columbia 20007
United States
Recruiting
Urological Research Network CORP
Hialeah, Florida 33016
United States
Recruiting Isabel H Lopez
786-431-2014
isabel@besturology.net
Woodlands Medical Specialist
Pensacola, Florida 32503
United States
Recruiting Leslie Bellamy
850-696-4423
lbellamy@woodlandsmed.com
Emory University
Atlanta, Georgia 30322
United States
Recruiting Kaleena Jesson
404-778-5993
Kaleena.Kristine.Jesson@emory.edu
Northwestern University Feinberg School of Medicine
Chicago, Illinois 60611
United States
Recruiting
UChicago Medicine Duchossois Center for Advanced Medicine (DCAM) - Hyde Park
Chicago, Illinois 60637
United States
Recruiting
DuPage Medical Group - Warrenville Road
Lisle, Illinois 60532
United States
Recruiting
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
United States
Recruiting Daniel Shao
317-274-0972
dsshao@iu.edu
Tulane University/Southeastern Louisiana VA Health Care
New Orleans, Louisiana 70112
United States
Recruiting Cara Rowe
504-988-0645
caraj@tulane.edu
Johns Hopkins Hospital
Baltimore, Maryland 21287
United States
Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Recruiting Guru Sonpavde
617-632-2429
gurup_sonpavde@dfci.harvard.edu
Saint Louis University- SLUCare Academic Pavilion
Saint Louis, Missouri 63110
United States
Recruiting
Nebraska Cancer Specialists - Midwest Cancer Center
Omaha, Nebraska 68130
United States
Recruiting
MD Anderson Cancer Center at Cooper
Camden, New Jersey 08103
United States
Recruiting Amanda Logan
856-735-6396
logan-amanda@cooperhealth.edu
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Recruiting
New Jersey Urology - Saddle Brook
Saddle Brook, New Jersey 07663
United States
Recruiting
New Jersey Urology
Voorhees, New Jersey 08043
United States
Recruiting Jennifer Pilallis
856-673-1613
jpilallis@njurology.com
Albany Medical College
Albany, New York 12208
United States
Recruiting Brenda Romeo
518-262-8579
AMCUrologyResearch@amc.edu
Associated Medical Professionals - Syracuse
Syracuse, New York 13210
United States
Recruiting
Duke University Cancer Center
Durham, North Carolina 27710
United States
Recruiting
University of Toledo
Arlington, Ohio 43606
United States
Recruiting Stephanie Smiddy
419-383-6962
Stephanie.smiddy@utoledo.edu
Oncology Hematology Care
Cincinnati, Ohio 45242
United States
Recruiting Doug Hart
513-751-2273
douglas.hart@usoncology.com
Cleveland Clinic
Cleveland, Ohio 44195
United States
Recruiting Victoria Wisnieski
216-444-8311
guptas5@ccf.org
The Ohio State University College of Medicine
Columbus, Ohio 43210
United States
Recruiting
Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Recruiting
Prisma Health Regional Urology
Greenville, South Carolina 29605
United States
Recruiting
Urology Associates, P.C.
Nashville, Tennessee 37209
United States
Recruiting Roxie Felton
615-250-9240
rcfelton@ua-pc.com
Texas Oncology - Houston Memorial City
Houston, Texas 77024
United States
Recruiting
Houston Methodist Hospital- Department of Urology
Houston, Texas 77030
United States
Recruiting Cinthya Yesenia Obando Perez Obando Perez, MD
346-238-6123
cobandoperez@houstonmethodist.com
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting
Texas Oncology
Longview, Texas 75601
United States
Recruiting Shelly Maxfield
903-757-2122
shelly.maxfield@usoncology.com
UT Southwestern
Richardson, Texas 75080
United States
Recruiting Laurin Priddy
972-669-7044
laurin.priddy@utsouthwestern.edu
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
Recruiting Kristen Jones
801-587-4385
alejandro.sanchez@hci.utah.edu
Virginia Oncology Associates - Norfolk
Norfolk, Virginia 23502
United States
Recruiting Gina Bright
757-466-8683
gina.bright@usoncology.com
QED Investigative Site
Seattle, Washington 98109
United States
Recruiting
West Virginia University
Morgantown, West Virginia 26506
United States
Recruiting
CHU de Liège - Sart Tilman
Liège, Liège/Belgium 4000
Belgium
Recruiting Amandine Catot
+ 32 4 366 76 64
pfreres@chuliege.be
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerpen, 202
Belgium
Recruiting
Cliniques Universitaires Saint-Luc
Brussel, 1200
Belgium
Recruiting
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
Canada
Recruiting
BC Cancer- Vancouver
Vancouver, British Columbia V5Z 4E6
Canada
Recruiting Lyn Lorenzen
604.877.6000
Bernard.Eigl@bccancer.bc.ca
Princess Margaret Cancer Centre
Toronto, Ontario M5G2M9
Canada
Recruiting Srikala Sridhar
416-946-4501
Srikala.Sridhar@uhn.ca
McGill University Health Centre (MUHC)
Montréal, Quebec H4A 3J1
Canada
Recruiting Dianna Leroux
514-934-1934
dianna.leroux@much.mcgill.ca
CHU de Québec Université Laval
Québec, G1R 2J6
Canada
Recruiting
Hôpital Universitaire Pitié Salpêtrière
Paris, Ile-de-France 75013
France
Recruiting
Hôpital Européen Georges-Pompidou
Paris, Ile-de-France 75015
France
Recruiting
QED Investigative Site
Nantes, Nantes/France 44093
France
Recruiting
QED Investigative Site
Paris, Paris/France 75018
France
Recruiting
Centre de Lutte Contre le Cancer - Centre Léon Bérard
Lyon, Rhone-Alpes 69008
France
Recruiting
Institut de Cancerologie Strasbourg Europe
Strasbourg, Strasbourg/France 67200
France
Recruiting Robert Anais
+33 3 68 76 7204
anais.robert@chru-strasbourg.fr
Institut Claudius Regaud
Toulouse, Toulouse/France 31059
France
Recruiting Estelle Thiot
+33 5 31 15 58 70
thiot.estelle@iuct-oncopole.fr
QED Investigative Site
Villejuif, Villejuif/France 94805
France
Recruiting
Charité Campus Mitte
Berlin, Berlin/Germany 10117
Germany
Recruiting
Universitätsklinikum Düsseldorf
Duesseldorf, Nordrhein-Westfalen 40225
Germany
Recruiting
Urologicum Duisburg
Duisburg, Nordrhein-WestFalen 47179
Germany
Recruiting Claudia Kleinfeld
+49 203 500304-0
hellmis@urologicum-duisburg.de
Universitätsklinikum Essen
Essen, Nordrhein-Westfalen 45147
Germany
Recruiting Micaela Löbert
+49 201 723 3213
viktor.gruenwald@uk-essen.de
Marien Hospital Herne - Universitätsklinikum der Ruhr-Universität Bochum
Herne, Nordrhein-Westfalen 44625
Germany
Recruiting Ayleen Bartels
+49 2323 499 5252
florian.roghmann@elisabethgruppe.de
Caritas-Krankenhaus St. Josef Klinik für Urologie
Regensburg, 93053
Germany
Recruiting Kathrin Hese
+49 941 782 3510
mschnabel@cartasstijosef.de
Universitätsklinikum Tübingen
Tübingen,
Germany
Recruiting Beatrice Welte
+49 707 129 86 613
arnulf.stenzl@med.uni-tubingen.de
Ospedale di Cremona
Cremona, Cremona/Italy 26100
Italy
Recruiting
Ospedale Policlinico San Martino
Genova, Genova/Italy 16132
Italy
Recruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Meldola/Italy 47014
Italy
Recruiting
Istituto Europeo di Oncologia
Milano, Milano/Italy 20141
Italy
Recruiting
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Napoli, Naples 80131
Italy
Recruiting
Azienda Ospedaliero-Universitaria Pisana
Pisa, Pisa/italy 56126
Italy
Recruiting
IRCCS Centro di Riferimento Oncologico di Basilicata
Rionero In Vulture, Potenza 85028
Italy
Recruiting
Arcispedale Santa Maria Nuova
Reggio Emilia, Reggio Emilia/Italy 42100
Italy
Recruiting
Università Campus Bio-Medico di Roma
Roma, Roma/Italy 00128
Italy
Recruiting
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano, Torino 10043
Italy
Recruiting
Ospedale di Trento - Presidio Ospedaliero Santa Chiara
Trento, Trentino 38100
Italy
Recruiting
Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari
Bari, 70124
Italy
Recruiting
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Gelderland 6532 SZ
Netherlands
Recruiting
Zuyderland Medisch Centrum Sittard-Geleen
Geleen, Limburg 6162 BG
Netherlands
Recruiting
Canisius-Wilhelmina Hospital
Nijmegen, Nigmegen/Gelderland 6532 SZ
Netherlands
Recruiting Roel Remij
+31 24-3658961
researchurologie@cwz.nl
QED Investigative Site
Geleen,
Netherlands
Recruiting
Centro Médico de Puerto Rico
Rio Piedras, 00935
Puerto Rico
Recruiting
QED Investigative SIte
Barcelona, Barcelona/Spain 08003
Spain
Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, Barcelona/Spain 08035
Spain
Recruiting Carlos Fernandez Saez
+34 932746085
rmorales@vhio.net
QED Investigative Site
Barcelona, Barcelona/Spain 08041
Spain
Recruiting
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
Barcelona, Barcelona/Spain 08908
Spain
Recruiting
Institut Català d'Oncologia Badalona
Badalona, Barcelona 08916
Spain
Recruiting
Hospital Parc Taulí de Sabadell
Sabadell, Barcelona 08208
Spain
Recruiting
Hospital Universitario Reina Sofía
Córdoba, Córdoba/Spain 14004
Spain
Recruiting
Institut Català d'Oncologia Girona
Girona, Girona/Spain 17007
Spain
Recruiting
MD Anderson Cancer Center Madrid
Madrid, Madrid/Spain 28033
Spain
Recruiting
Hospital Universitario Ramon y Cajal
Madrid, Madrid/Spain 28034
Spain
Recruiting Daniel G. Palos
+34 91 336 80 00
pgajate@oncologiahrc.com
Hospital Clinico San Carlos
Madrid, Madrid/Spain 28040
Spain
Recruiting Ines de Cardenas
+34913303182
javier.puente@salud.madrid.org
Hospital Universitario 12 de Octubre
Madrid, Madrid/Spain 28041
Spain
Recruiting Jonathan Lucas
+34 914603310
cdanicas@hotmail.com
Hospital Universitario La Paz
Madrid, Madrid/Spain 28046
Spain
Recruiting Susana Feliu
+34 91 727 70 50
alvaropintomarin@gmail.com
Hospital Universitario HM Sanchinarro
Madrid, Madrid/Spain 28050
Spain
Recruiting Patricia Morgades
+34917500193
esevillano@hmhospitales.com
Hospital Universitario Virgen del Rocio
Sevilla, Sevilla/Spain 41013
Spain
Recruiting Cristina De Silva
+34954232992
bpvalderrama@gmail.com
Hospital Virgen De La Salud
Toledo, Toledo/Spain 45005
Spain
Recruiting
Fundacion Instituto Valenciano de Oncologia
Valencia, València 46009
Spain
Recruiting
Sarah Cannon Research Institute London
London, England W1G 6AD
United Kingdom
Recruiting Tasmia Manir
0203.219.5200
Anna.Patikdou@hcahealthcare.co.uk