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Brief Title: Study of Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations

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)

INTRODUCTION

  • Org Study ID: QBGJ398-302
  • Secondary ID: 2019-003248-63
  • NTC ID: NCT04197986
  • Sponsor: QED Therapeutics, Inc.

BRIEF SUMMARY

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of infigratinib (an oral targeted FGFR1-3 inhibitor) versus placebo, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or 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 1:1 between infigratinib or placebo with treatment up to 1 year or until invasive local, distal, or metastatic disease recurrence confirmed by independent imaging reviewer.

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

PRIMARY OUTCOMES

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

Primary Outcome 1 - Timeframe: Randomization through up to an approximated 5 years (60 months) after end of treatment

CONDITION

  • Upper Tract Urothelial Carcinomas
  • Urothelial Bladder Cancer

ELIGIBILITY

Key Inclusion Criteria
Are randomized within 120 days following nephroureterectomy, distal ureterectomy or cystectomy.
Have histologically or cytologically confirmed, invasive urothelial carcinoma with susceptible FGFR3 alterations. Variant histology is allowed provided urothelial carcinoma is predominant (>50%). Neuroendocrine (including small and large cell), sarcomatoid, and plasmacytoid variants are excluded (any component).
Regarding samples and documentation of FGFR3
i. FGFR3 mutation is confirmed if: FGFR3 gene is mutated in Exon 7 (R248C, S249C), Exon 10 (G370C, A391E, Y373C), or Exon 15 (K650M/T, K650E/Q)
OR
ii. FGFR3 gene fusion or FGFR3 rearrangement is confirmed based on the following genomic criteria if:
Any fusion/rearrangement with a literature-derived known partner gene regardless of strand or frame.

- Fusion/rearrangements in the same strand that are in frame with a novel partner gene.

- Fusion/rearrangements with one breakpoint in the intron 17 - exon 18 hotspot region and the other breakpoint in an intergenic region or another gene. This rule excludes 3' duplications comprising only exon 18.

- iii. The amino acid numbers for the FGFR3 mutations refer to the functional FGFR3 isoform 1 (NP_000133.1) that is the NCBI Refseq ID used to report genetic alterations in FGFR3 by the FoundationOne® CDx test (F1CDx, Foundation Medicine, USA).
iv. FGFR3 alteration must be confirmed by Foundation Medicine for F1CDx testing:
The tumor sample to be used should be from the definitive surgical resection (cystectomy, nephroureterectomy, or distal ureterectomy), or from an archival biopsy of confirmed invasive urothelial carcinoma (≥pT2).

- If status post neoadjuvant chemotherapy, pathologic stage at surgical resection must be Stage ≥ ypT2 and/or yN+. Prior neoadjuvant therapy is defined as at least 3 cycles of neoadjuvant cisplatin-based chemotherapy with a planned cisplatin dose of 70 mg/m2/cycle. Subjects who received less than this or non-cisplatin-based neoadjuvant treatment are not excluded.

- If not status post neoadjuvant chemotherapy, is ineligible to receive cisplatin-based adjuvant chemotherapy based on Galsky criteria:

- Subjects who refuse cisplatin-based chemotherapy or who are ineligible to receive cisplatin-based chemotherapy based on Galsky criteria must also meet the following criteria:

- Must have a centrally reviewed negative postoperative computed tomography (CT) (defined as lymph nodes with short axis <1.0 cm and without growth and no distant metastases according to [RECIST v1.1 criteria or negative biopsy within 28 days before randomization to confirm absence of disease at baseline. - Have Eastern Cooperative Oncology Group (ECOG) performance status of ≤2. - If a woman of childbearing potential, must have a negative pregnancy test within 7 days of the first dose of study drug. Sexually active males must use a condom during intercourse while taking study drug and for 1 month after the last dose of study drug and should not father a child during this period
Key Exclusion Criteria:
Presence of positive invasive surgical margins following nephroureterectomy, distal ureterectomy, or cystectomy. In subjects not eligible for further surgery, radiotherapy, or other efficacious treatment, microscopic positive noninvasive margins (eg, carcinoma in situ) without gross residual disease are allowed.

- Have received Bacillus Calmette-Guerin (BCG) or other intravesical therapy for Non-Muscle Invasive Bladder Cancer (NMIBC) within the previous 30 days.
Are currently receiving or are planning to receive during participation in this study, treatment with agents that are known moderate or strong inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus and/or calcium concentration. Prior anticancer or other therapies are restricted as follows:
Prior adjuvant treatment for urothelial cancer is not allowed.

- Prior neoadjuvant therapy (eg, chemotherapy, immunotherapy, or investigational) is allowed if inclusion criterion #4 is met. Prior neoadjuvant chemotherapy must have been completed within a period of time that is greater than the cycle length used for that treatment before first dose of study drug.

- Prior biologic, immunotherapy, or investigational therapy should have been completed within a period that is ≥5 half-lives or 30 days, whichever is shorter, before the first dose of study drug.

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

- Have a history of primary malignancy within the past 3 years other than (1) invasive UBC or UTUC (ie, disease under study), (2) noninvasive urothelial carcinoma, (3) any adequately treated in situ carcinoma or non-melanoma carcinoma of the skin, (4) any other curatively treated malignancy that is not expected to require treatment for recurrence during participation in the study, or (5) an untreated cancer on active surveillance that may not affect the subject's survival status for ≥3 years based on clinician assessment/statement and with medical monitor approval.

- Have current evidence of corneal keratopathy or retinal disorder confirmed by ophthalmic examination. Subjects with asymptomatic ophthalmic conditions assessed by the investigator to pose minimal risk for study participation may be enrolled in the study.

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

- Have impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib

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

- Have consumed grapefruit, grapefruit juice, grapefruit hybrids, pomegranates, star fruits, pomelos, or Seville oranges or products containing juice of these fruits within 7 days before the first dose of study drug; have taken any Chinese herbal medicine or Chinese patent medicine treatments with anticancer activity within 14 days of the first dose of study drug.
Have insufficient bone marrow function:
Absolute neutrophil count (ANC) <1,000/mm3 (1.0 × 109/L). - Platelets <75,000/mm3 (<75 × 109/L). - Hemoglobin <8.5 g/dL; transfusion support is allowed if >1 week before randomization and hemoglobin remains stable.
Have insufficient hepatic and renal function:
Total bilirubin >1.5 × upper limit of normal (ULN) of the testing laboratory (for subjects with documented Gilbert syndrome, direct bilirubin must be ≤1.5 × ULN and enrollment requires approval by the medical monitor).

- AST/SGOT and ALT/SGPT >2.5 × ULN of the testing laboratory.

- Serum creatinine >1.5 × ULN or a calculated or measured creatinine clearance of <30 mL/min. - Have amylase or lipase >2.0 × ULN.
Have abnormal calcium or phosphorus:
Inorganic phosphorus higher than 1.02 × ULN of the testing laboratory.

- Total serum calcium (can be corrected) higher than 1.02 × ULN of the testing laboratory.
Have clinically significant cardiac disease including any of the following:
New York Heart Association (NYHA) Class ≥2B; subjects with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the NYHA classification.

- Uncontrolled hypertension

- Presence of CTCAE v5.0 Grade ≥2 ventricular arrhythmias, atrial fibrillation, bradycardia, or conduction abnormality.

- Unstable angina pectoris or acute myocardial infarction ≤3 months before the first dose of study drug.

- Average QTcF >470 msec (males and females). Note: If the QTcF is >470 msec in the first ECG, a total of 3 ECGs separated by ≥5 minutes should be performed. If the average of these 3 consecutive results for QTcF is ≤470 msec, the subject meets eligibility in this regard.

- History of congenital long QT syndrome.

- Have had a recent (≤3 months before the first dose of study drug) transient ischemic attack or stroke.

- If female, are pregnant or nursing (lactating).

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, Inc.

Overall Contact

Name: Corina Andresen, MD

Phone: 1-877-280-5655

Email: Proof302.ct@qedtx.com

LOCATION

Facility Status Contact
Facility: The University of Alabama at Birmingham
Birmingham, Alabama 35233
United States
Status: Recruiting Contact: Contact
Cara Porter
205-975-2691 2520
abasu@uabmc.edu
Facility: Arizona Oncology Associates
Tucson, Arizona 85711
United States
Status: Recruiting Contact: Principal Investigator
Arnab Basu, MD
520-668-5678 35161
stacey.kimbell@usoncology.com
Facility: City of Hope - Duarte
Duarte, California 91010
United States
Status: Recruiting Contact: Contact
Stacey Kimbell
626-256-4673
tisanchez@liu.edu
Facility: City of Hope
Duarte, California 91010
United States
Status: Recruiting Contact: Principal Investigator
Samantha Pal
909-558-4050
daneshma@usc.edu
Facility: Loma Linda University Faculty Medical Clinics
Loma Linda, California 92350
United States
Status: Recruiting Contact: Contact
Sumanta Pal, M.D.
323-865-3000
lkarsh@tucc.com
Facility: USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Status: Recruiting Contact: Contact
Tiffany Sanchez
303-433-4776
isabel@besturology.net
Facility: QED Investigative Site
Sacramento, California 95817
United States
Status: Recruiting Contact: Principal Investigator
Brian Hu
786-431-2014
lbellamy@woodlandsmed.com
Facility: UC Davis Medical Center
Sacramento, California 95817
United States
Status: Recruiting Contact: Contact
Cheryl Kefauver
850-696-4423
lbellamy@woodlandsmed.com
Facility: University of Colorado Cancer Center
Aurora, Colorado 80045
United States
Status: Recruiting Contact: Contact
Lawrence Karsh
850-696-4423
Kaleena.Kristine.Jesson@emory.edu
Facility: Rocky Mountain Cancer Center
Colorado Springs, Colorado 80907
United States
Status: Recruiting Contact: Contact
Isabel H Lopez
404-778-5993
dsshao@iu.edu
Facility: The Urology Center of Colorado
Denver, Colorado 80211
United States
Status: Recruiting Contact: Contact
Leslie Bellamy
317-274-0972
dsshao@iu.edu
Facility: Georgetown University Medical Center
Washington, District of Columbia 20007
United States
Status: Recruiting Contact: Principal Investigator
Rami Owera
317-274-0972
caraj@tulane.edu
Facility: Urological Research Network CORP
Hialeah, Florida 33016
United States
Status: Recruiting Contact: Contact
Leslie Bellamy
504-988-0645
gurup_sonpavde@dfci.harvard.edu
Facility: Mayo Clinic - Jacksonville
Jacksonville, Florida 32224
United States
Status: Recruiting Contact: Contact
Kaleena Jesson
617-632-2429
logan-amanda@cooperhealth.edu
Facility: Lakeland Regional Health Hollis Cancer Center
Lakeland, Florida 33805
United States
Status: Recruiting Contact: Principal Investigator
Viraj Master
856-735-6396
jpilallis@njurology.com
Facility: Woodlands Medical Specialists
Pensacola, Florida 32503
United States
Status: Recruiting Contact: Contact
Daniel Shao
856-673-1613
amcurologyresearch@amc.edu
Facility: Woodlands Medical Specialist
Pensacola, Florida 32503
United States
Status: Recruiting Contact: Principal Investigator
Nabil Adra
518-262-8579
AMCUrologyResearch@amc.edu
Facility: Emory University
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: Contact
Daniel Shao
518-262-8579
whitney.franz@duke.edu
Facility: Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: Contact
Cara Rowe
919-668-6290
Stephanie.smiddy@utoledo.edu
Facility: Northwestern University Feinberg School of Medicine
Chicago, Illinois 60611
United States
Status: Recruiting Contact: Contact
Guru Sonpavde
419-383-6962
douglas.hart@usoncology.com
Facility: UChicago Medicine Duchossois Center for Advanced Medicine (DCAM) - Hyde Park
Chicago, Illinois 60637
United States
Status: Recruiting Contact: Contact
Amanda Logan
513-751-2273
guptas5@ccf.org
Facility: DuPage Medical Group - Warrenville Road
Lisle, Illinois 60532
United States
Status: Recruiting Contact: Contact
Jennifer Pilallis
216-444-8311
stephanie.smiddy@utoledo.edu
Facility: Indiana University Health Physicians - Urology
Indianapolis, Indiana 46202
United States
Status: Recruiting Contact: Contact
Brenda Romeo
419-383-6962
rcfelton@ua-pc.com
Facility: Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
United States
Status: Recruiting Contact: Principal Investigator
Badar Mian, MD
615-250-9240
laurin.priddy@utsouthwestern.edu
Facility: Tulane University/Southeastern Louisiana VA Health Care
New Orleans, Louisiana 70112
United States
Status: Recruiting Contact: Contact
Brenda Romeo
972-669-7044
cobandoperez@houstonmethodist.com
Facility: Johns Hopkins Hospital
Baltimore, Maryland 21287
United States
Status: Recruiting Contact: Contact
Whitney Franz
346-238-6123
shelly.maxfield@usoncology.com
Facility: Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: Principal Investigator
Brant Inman
903-757-2122
shelly.maxfield@usoncology.com
Facility: Saint Louis University- SLUCare Academic Pavilion
Saint Louis, Missouri 63110
United States
Status: Recruiting Contact: Principal Investigator
Matthew Logsdon
903-757-2122
laurin.priddy@utsouthwestern.edu
Facility: Nebraska Cancer Specialists - Midwest Cancer Center
Omaha, Nebraska 68130
United States
Status: Recruiting Contact: Contact
Stephanie Smiddy
972-669-7044
alejandro.sanchez@hci.utah.edu
Facility: University of Nebraska Medical Center
Omaha, Nebraska 68198
United States
Status: Recruiting Contact: Principal Investigator
David Waterhouse
801-587-4385
gina.bright@usoncology.com
Facility: Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03766
United States
Status: Recruiting Contact: Contact
Doug Hart
757-466-8683
pfreres@chuliege.be
Facility: MD Anderson Cancer Center at Cooper
Camden, New Jersey 08103
United States
Status: Recruiting Contact: Principal Investigator
David Waterhouse
+ 32 4 366 76 64
bertrand.tombal@uclouvain.be
Facility: John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Status: Recruiting Contact: Contact
Victoria Wisnieski
+32 2 764 35 46
scott.north@ahs.ca
Facility: New Jersey Urology - Saddle Brook
Saddle Brook, New Jersey 07663
United States
Status: Recruiting Contact: Contact
Stephanie Smiddy, RN
780-432-8762
Bernard.Eigl@bccancer.bc.ca
Facility: New Jersey Urology
Voorhees, New Jersey 08043
United States
Status: Recruiting Contact: Principal Investigator
Firas Petros, MD
604.877.6000
Srikala.Sridhar@uhn.ca
Facility: Albany Medical Center - Division of Urology
Albany, New York 12208
United States
Status: Recruiting Contact: Contact
Roxie Felton
416-946-4501
dianna.leroux@much.mcgill.ca
Facility: Albany Medical College
Albany, New York 12208
United States
Status: Recruiting Contact: Principal Investigator
Gautam Jayram
514-934-1934
bernhard.eigi@bccancer.bc.ca
Facility: Associated Medical Professionals - Syracuse
Syracuse, New York 13210
United States
Status: Recruiting Contact: Contact
Laurin Priddy
604-877-6000
anais.robert@chru-strasbourg.fr
Facility: Duke University Cancer Center
Durham, North Carolina 27710
United States
Status: Recruiting Contact: Principal Investigator
Suzanne Cole, MD
+33 3 68 76 7204
a.robert@icans.eu
Facility: Accellacare-DuPage Medical Group
Raleigh, North Carolina 27609
United States
Status: Recruiting Contact: Principal Investigator
Seth Lerner
+33 5 31 15 58 70
thiot.estelle@iuct-oncopole.fr
Facility: Rocky Mountain Cancer Center
Rocky Mount, North Carolina 27804
United States
Status: Recruiting Contact: Contact
Cinthya Yesenia Obando Perez Obando Perez, MD
+49 30 450 615 187
maria.de-santis@charite.de
Facility: Wake Forest Baptist Health
Winston-Salem, North Carolina 27157
United States
Status: Recruiting Contact: Contact
Shelly Maxfield
+49 203 500304-0
hellmis@urologicum-duisburg.de
Facility: University of Toledo
Arlington, Ohio 43606
United States
Status: Recruiting Contact: Principal Investigator
Lijo John
+49 201 723 3213
viktor.gruenwald@uk-essen.de
Facility: Oncology Hematology Care - Blue Ash
Cincinnati, Ohio 45242
United States
Status: Recruiting Contact: Contact
Shelly Maxfield
+49 2323 499 5252
florian.roghmann@elisabethgruppe.de
Facility: Oncology Hematology Care
Cincinnati, Ohio 45242
United States
Status: Recruiting Contact: Contact
Laurin Priddy
+49 30 450 616 187
maria.de-santis@charite.de
Facility: Cleveland Clinic
Cleveland, Ohio 44195
United States
Status: Recruiting Contact: Principal Investigator
Alejandro Sanchez
+49 68 41 16 24 777
julia.heinzelbecker@uks.eu
Facility: The Ohio State University College of Medicine
Columbus, Ohio 43210
United States
Status: Recruiting Contact: Contact
Kristen Jones
+49 391 67 15 034
andreas.janitzky@med.ovgu.de
Facility: The University of Toledo Medical Center
Toledo, Ohio 43614
United States
Status: Recruiting Contact: Contact
Gina Bright
+49 941 782 3510
mschnabel@cartasstijosef.de
Facility: Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact: Contact
Amandine Catot
+49 707 129 86 613
arnulf.stenzl@med.uni-tubingen.de
Facility: Prisma Health Regional Urology
Greenville, South Carolina 29605
United States
Status: Recruiting Contact: Principal Investigator
Dirk Schrijvers
+31 24-3658961
researchurologie@cwz.nl
Facility: Urology Associates, P.C.
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: Contact
Anne-Marie Salumu Ekendji
+34 932746085
rmorales@vhio.net
Facility: Urology Associates
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: Principal Investigator
Bertrand Tombal
+34 91 336 80 00
pgajate@oncologiahrc.com
Facility: Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas 75390
United States
Status: Recruiting Contact: Contact
Tammy Hale
+34915183232
javier.puente@salud.madrid.org
Facility: Texas Oncology - Houston Memorial City
Houston, Texas 77024
United States
Status: Recruiting Contact: Principal Investigator
Scott North
+34913303182
cdanicas@hotmail.com
Facility: Bayor College of Medicine
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Lyn Lorenzen
+34 914603310
alvaropintomarin@gmail.com
Facility: Houston Methodist Hospital- Department of Urology
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Srikala Sridhar
+34 91 727 70 50
esevillano@hmhospitales.com
Facility: The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Dianna Leroux
+34 91 7277118
bpvalderrama@gmail.com
Facility: Texas Oncology - Longview Cancer Center
Longview, Texas 75601
United States
Status: Recruiting Contact: Contact
Lyn Lorenzen
+34917500193
Anna.Patikdou@hcahealthcare.co.uk
Facility: Texas Oncology
Longview, Texas 75601
United States
Status: Recruiting Contact: Principal Investigator
Bernhard J Eigl
+34954232992
Facility: UT Southwestern
Richardson, Texas 75080
United States
Status: Recruiting Contact: Contact
Robert Anais
0203.219.5200
Facility: Urology San Antonio
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Estelle Thiot

Facility: Huntsman Cancer Institute and Hospital
Salt Lake City, Utah 84112
United States
Status: Recruiting Contact: Contact
Anika Biniszkiewicz

Facility: Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
Status: Recruiting Contact: Contact
Maria De Santis, PD MD

Facility: Virginia Oncology Associates - Norfolk
Norfolk, Virginia 23502
United States
Status: Recruiting Contact: Principal Investigator
Claudia Kleinfeld

Facility: QED Investigative Site
Seattle, Washington 98109
United States
Status: Recruiting Contact: Contact
Micaela Löbert

Facility: Seattle Cancer Care Alliance
Seattle, Washington 98109
United States
Status: Recruiting Contact: Contact
Ayleen Bartels

Facility: West Virginia University
Morgantown, West Virginia 26506
United States
Status: Recruiting Contact: Contact
Anika Biniszkiewicz

Facility: CHU de Liège - Sart Tilman
Liège, Liège/Belgium 4000
Belgium
Status: Recruiting Contact: Contact
Maria De Santis

Facility: Ziekenhuis Netwerk Antwerpen Middelheim
Antwerpen, Alberta 202
Belgium
Status: Recruiting Contact: Principal Investigator
Guenter Niegisch

Facility: ZNA Middelheim
Antwerpen, British Columbia 1200
Belgium
Status: Recruiting Contact: Principal Investigator
Tanja Lauer

Facility: Cliniques Universitaires Saint-Luc
Brussel, Ontario T6G 1Z2
Belgium
Status: Recruiting Contact: Contact
Julia Heinzelbecker

Facility: Universitair Ziekenhuis Leuven
Leuven, Quebec V5Z 4E6
Belgium
Status: Recruiting Contact: Principal Investigator
Simone Nitschke

Facility: Cross Cancer Institute
Edmonton, Ile-de-France M5G2M9
Canada
Status: Recruiting Contact: Contact
Andreas Janitzky

Facility: BC Cancer- Vancouver
Vancouver, Ile-de-France H4A 3J1
Canada
Status: Recruiting Contact: Principal Investigator
Kathrin Hese

Facility: Princess Margaret Cancer Centre
Toronto, Nantes/France G1R 2J6
Canada
Status: Recruiting Contact: Contact
Beatrice Welte

Facility: McGill University Health Centre (MUHC)
Montréal, Paris/France 75013
Canada
Status: Recruiting Contact: Contact
Amulf Stenzl

Facility: CHU de Québec Université Laval
Québec, Rhone-Alpes 75015
Canada
Status: Recruiting Contact: Principal Investigator
Roel Remij

Facility: BC Cancer - Vancouver
Vancouver, Strasbourg/France 44093
Canada
Status: Recruiting Contact: Contact
Carlos Fernandez Saez

Facility: Hôpital Universitaire Pitié Salpêtrière
Paris, Toulouse/France 75018
France
Status: Recruiting Contact: Contact
Daniel G. Palos

Facility: Hôpital Européen Georges-Pompidou
Paris, Villejuif/France 69008
France
Status: Recruiting Contact: Contact
Ines de Cardenas

Facility: QED Investigative Site
Nantes, Berlin/Germany 67200
France
Status: Recruiting Contact: Contact
Jonathan Lucas

Facility: QED Investigative Site
Paris, Nordrhein-Westfalen 31059
France
Status: Recruiting Contact: Contact
Susana Feliu

Facility: Centre de Lutte Contre le Cancer - Centre Léon Bérard
Lyon, Nordrhein-WestFalen 94805
France
Status: Recruiting Contact: Contact
Patricia Morgades

Facility: Institut de Cancerologie Strasbourg Europe
Strasbourg, Nordrhein-Westfalen 10117
France
Status: Recruiting Contact: Contact
Elena Sevillano Fernandez

Facility: Institut Claudius Regaud
Toulouse, Nordrhein-Westfalen 40225
France
Status: Recruiting Contact: Contact
Cristina De Silva

Facility: QED Investigative Site
Villejuif, Cremona/Italy 47179
France
Status: Recruiting Contact: Contact
Tasmia Manir

Facility: CHU de Nantes Hopital Hotel Dieu
Nantes, Genova/Italy 45147
France
Status: Recruiting Contact: Principal Investigator
Deborah Enting

Facility: Hopital Bichat - Claude - Bernard
Paris, Meldola/Italy 44625
France
Status: Recruiting Contact: Contact


Facility: Institut De Cancerologie De L'ouest - Site Saint-Herblain
Saint-Herblain, Milano/Italy 93053
France
Status: Recruiting Contact: Contact


Facility: Gustave Roussy
Villejuif, Naples 26100
France
Status: Recruiting Contact: Principal Investigator


Facility: Charité - Universitatsmedizin Berlin
Berlin, Pisa/italy 16132
Germany
Status: Recruiting Contact: N/A
Facility: Universitätsklinikum Düsseldorf
Duesseldorf, Potenza 47014
Germany
Status: Recruiting Contact: N/A
Facility: Urologicum Duisburg
Duisburg, Reggio Emilia/Italy 20141
Germany
Status: Recruiting Contact: N/A
Facility: Universitätsklinikum Essen
Essen, Roma/Italy 80131
Germany
Status: Recruiting Contact: N/A
Facility: Marien Hospital Herne - Universitätsklinikum der Ruhr-Universität Bochum
Herne, Torino 56126
Germany
Status: Recruiting Contact: N/A
Facility: Charite Universitaetsmedizin Berlin
Berlin, Trentino 85028
Germany
Status: Recruiting Contact: N/A
Facility: University Hospital Duesseldorf
Duesseldorf, Gelderland 42100
Germany
Status: Recruiting Contact: N/A
Facility: Universitatsklinikum des Saarlandes Klinik fur Urologie & Kinderurologie
Homburg/saar, Limburg 00128
Germany
Status: Recruiting Contact: N/A
Facility: Universitatsklinikum Magdeburg
Magdeburg, Nigmegen/Gelderland 10043
Germany
Status: Recruiting Contact: N/A
Facility: Caritas-Krankenhaus St. Josef Klinik für Urologie
Regensburg, Barcelona/Spain 38100
Germany
Status: Recruiting Contact: N/A
Facility: Universitätsklinikum Tübingen
Tübingen, Barcelona/Spain 70124
Germany
Status: Recruiting Contact: N/A
Facility: Ospedale di Cremona
Cremona, Barcelona/Spain 6532 SZ
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale Policlinico San Martino
Genova, Barcelona/Spain 6162 BG
Italy
Status: Recruiting Contact: N/A
Facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Barcelona 6532 SZ
Italy
Status: Recruiting Contact: N/A
Facility: Istituto Europeo di Oncologia
Milano, Barcelona 00935
Italy
Status: Recruiting Contact: N/A
Facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Napoli, Córdoba/Spain 00902
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliero-Universitaria Pisana
Pisa, Girona/Spain 08003
Italy
Status: Recruiting Contact: N/A
Facility: IRCCS Centro di Riferimento Oncologico di Basilicata
Rionero In Vulture, Madrid/Spain 08035
Italy
Status: Recruiting Contact: N/A
Facility: Arcispedale Santa Maria Nuova
Reggio Emilia, Madrid/Spain 08041
Italy
Status: Recruiting Contact: N/A
Facility: Università Campus Bio-Medico di Roma
Roma, Madrid/Spain 08908
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano, Madrid/Spain 08916
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale di Trento - Presidio Ospedaliero Santa Chiara
Trento, Madrid/Spain 08208
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari
Bari, Madrid/Spain 14004
Italy
Status: Recruiting Contact: N/A
Facility: A.O.U.C. Polclinico di Bari U.O. Oncologia Medica Universitaria
Bari, Sevilla/Spain 17007
Italy
Status: Recruiting Contact: N/A
Facility: ASST Cremona
Casalmaggiore, Toledo/Spain 28033
Italy
Status: Recruiting Contact: N/A
Facility: Int Pascale Napoli
Napoli, València 28034
Italy
Status: Recruiting Contact: N/A
Facility: AOU San Luigi Gonzaga
Orbassano, England 28040
Italy
Status: Recruiting Contact: N/A
Facility: IRCCS di Reggio Emilia
Reggio Emilia, 28041
Italy
Status: Recruiting Contact: N/A
Facility: Policlinico Universitario Campus Biomedico
Roma, 28046
Italy
Status: Recruiting Contact: N/A
Facility: Citta Della Salute e Della Scienz - Torino
Torino, 28050
Italy
Status: Recruiting Contact: N/A
Facility: Canisius-Wilhelmina Ziekenhuis
Nijmegen, 41013
Netherlands
Status: Recruiting Contact: N/A
Facility: Zuyderland Medisch Centrum Sittard-Geleen
Geleen, 45005
Netherlands
Status: Recruiting Contact: N/A
Facility: Canisius-Wilhelmina Hospital
Nijmegen, 46009
Netherlands
Status: Recruiting Contact: N/A
Facility: The Netherlands Cancer Institute
Amsterdam, W1G 6AD
Netherlands
Status: Recruiting Contact: N/A
Facility: QED Investigative Site
Geleen,
Netherlands
Status: Recruiting Contact: N/A
Facility: Centro Médico de Puerto Rico
Rio Piedras,
Puerto Rico
Status: Recruiting Contact: N/A
Facility: Pan American Center for Oncology Trials, LLC
San Juan,
Puerto Rico
Status: Recruiting Contact: N/A
Facility: QED Investigative SIte
Barcelona,
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Vall d'Hebron
Barcelona,
Spain
Status: Recruiting Contact: N/A
Facility: QED Investigative Site
Barcelona,
Spain
Status: Recruiting Contact: N/A
Facility: Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
Barcelona,
Spain
Status: Recruiting Contact: N/A
Facility: Institut Català d'Oncologia Badalona
Badalona,
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Parc Taulí de Sabadell
Sabadell,
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Reina Sofía
Córdoba,
Spain
Status: Recruiting Contact: N/A
Facility: Institut Català d'Oncologia Girona
Girona,
Spain
Status: Recruiting Contact: N/A
Facility: MD Anderson Cancer Center Madrid
Madrid,
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Ramon y Cajal
Madrid,
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Clinico San Carlos
Madrid,
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario 12 de Octubre
Madrid,
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario La Paz
Madrid,
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario HM Sanchinarro
Madrid,
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Virgen del Rocio
Sevilla,
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Virgen De La Salud
Toledo,
Spain
Status: Recruiting Contact: N/A
Facility: Fundacion Instituto Valenciano de Oncologia
Valencia,
Spain
Status: Recruiting Contact: N/A
Facility: Hospital de la Santa Creu i Sant Pau
Barcelona,
Spain
Status: Recruiting Contact: N/A
Facility: Hospital del Mar
Barcelona,
Spain
Status: Recruiting Contact: N/A
Facility: Insitut Catala De Oncologia de Girona
Girona,
Spain
Status: Recruiting Contact: N/A
Facility: Sarah Cannon Research Institute London
London,
United Kingdom
Status: Recruiting Contact: N/A
Facility: Guy's and St Thomas' NHS Foundation Trust
London,
United Kingdom
Status: Recruiting Contact: N/A