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Brief Title: 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: Arizona Oncology Associates
Tucson, Arizona 85711
United States
Status: Recruiting Contact: Contact
Stacey Kimbell
520-668-5678 2520
stacey.kimbell@usoncology.com
Facility: City of Hope - Duarte
Duarte, California 91010
United States
Status: Recruiting Contact: Principal Investigator
Samantha Pal
626-256-4673 35161
tisanchez@liu.edu
Facility: City of Hope
Duarte, California 91010
United States
Status: Recruiting Contact: Contact
Sumanta Pal, M.D.
909-558-4050
daneshma@usc.edu
Facility: Loma Linda University Faculty Medical Clinics
Loma Linda, California 92350
United States
Status: Recruiting Contact: Contact
Tiffany Sanchez
323-865-3000
lkarsh@tucc.com
Facility: USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Status: Recruiting Contact: Principal Investigator
Brian Hu
303-433-4776
isabel@besturology.net
Facility: University of Colorado Cancer Center
Aurora, Colorado 80045
United States
Status: Recruiting Contact: Contact
Cheryl Kefauver
786-431-2014
Kaleena.Kristine.Jesson@emory.edu
Facility: The Urology Center of Colorado
Denver, Colorado 80211
United States
Status: Recruiting Contact: Contact
Lawrence Karsh
404-778-5993
dsshao@iu.edu
Facility: Georgetown University Medical Center
Washington, District of Columbia 20007
United States
Status: Recruiting Contact: Contact
Isabel H Lopez
317-274-0972
caraj@tulane.edu
Facility: Urological Research Network CORP
Hialeah, Florida 33016
United States
Status: Recruiting Contact: Contact
Kaleena Jesson
504-988-0645
jpilallis@njurology.com
Facility: Mayo Clinic - Jacksonville
Jacksonville, Florida 32224
United States
Status: Recruiting Contact: Principal Investigator
Viraj Master
856-673-1613
amcurologyresearch@amc.edu
Facility: Lakeland Regional Health Hollis Cancer Center
Lakeland, Florida 33805
United States
Status: Recruiting Contact: Contact
Daniel Shao
518-262-8579
whitney.franz@duke.edu
Facility: Emory University
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: Contact
Cara Rowe
919-668-6290
Stephanie.smiddy@utoledo.edu
Facility: Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: Contact
Jennifer Pilallis
419-383-6962
douglas.hart@usoncology.com
Facility: Northwestern University Feinberg School of Medicine
Chicago, Illinois 60611
United States
Status: Recruiting Contact: Contact
Brenda Romeo
513-751-2273
guptas5@ccf.org
Facility: UChicago Medicine Duchossois Center for Advanced Medicine (DCAM) - Hyde Park
Chicago, Illinois 60637
United States
Status: Recruiting Contact: Principal Investigator
Badar Mian, MD
216-444-8311
stephanie.smiddy@utoledo.edu
Facility: DuPage Medical Group - Warrenville Road
Lisle, Illinois 60532
United States
Status: Recruiting Contact: Contact
Whitney Franz
419-383-6962
laurin.priddy@utsouthwestern.edu
Facility: Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
United States
Status: Recruiting Contact: Principal Investigator
Brant Inman
972-669-7044
cobandoperez@houstonmethodist.com
Facility: Tulane University/Southeastern Louisiana VA Health Care
New Orleans, Louisiana 70112
United States
Status: Recruiting Contact: Contact
Stephanie Smiddy
346-238-6123
laurin.priddy@utsouthwestern.edu
Facility: Johns Hopkins Hospital
Baltimore, Maryland 21287
United States
Status: Recruiting Contact: Contact
Doug Hart
972-669-7044
pfreres@chuliege.be
Facility: Saint Louis University- SLUCare Academic Pavilion
Saint Louis, Missouri 63110
United States
Status: Recruiting Contact: Principal Investigator
David Waterhouse
+ 32 4 366 76 64
bertrand.tombal@uclouvain.be
Facility: University of Nebraska Medical Center
Omaha, Nebraska 68198
United States
Status: Recruiting Contact: Contact
Victoria Wisnieski
+32 2 764 35 46
scott.north@ahs.ca
Facility: Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03766
United States
Status: Recruiting Contact: Contact
Stephanie Smiddy, RN
780-432-8762
Bernard.Eigl@bccancer.bc.ca
Facility: John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Status: Recruiting Contact: Principal Investigator
Firas Petros, MD
604.877.6000
Srikala.Sridhar@uhn.ca
Facility: New Jersey Urology - Saddle Brook
Saddle Brook, New Jersey 07663
United States
Status: Recruiting Contact: Principal Investigator
Gautam Jayram
416-946-4501
dianna.leroux@much.mcgill.ca
Facility: New Jersey Urology
Voorhees, New Jersey 08043
United States
Status: Recruiting Contact: Contact
Laurin Priddy
514-934-1934
bernhard.eigi@bccancer.bc.ca
Facility: Albany Medical Center - Division of Urology
Albany, New York 12208
United States
Status: Recruiting Contact: Principal Investigator
Suzanne Cole, MD
604-877-6000
anais.robert@chru-strasbourg.fr
Facility: Associated Medical Professionals - Syracuse
Syracuse, New York 13210
United States
Status: Recruiting Contact: Principal Investigator
Seth Lerner
+33 3 68 76 7204
a.robert@icans.eu
Facility: Duke University Cancer Center
Durham, North Carolina 27710
United States
Status: Recruiting Contact: Contact
Cinthya Yesenia Obando Perez Obando Perez, MD
+33 5 31 15 58 70
thiot.estelle@iuct-oncopole.fr
Facility: Accellacare-DuPage Medical Group
Raleigh, North Carolina 27609
United States
Status: Recruiting Contact: Contact
Laurin Priddy
+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: Principal Investigator
Alejandro Sanchez
+49 203 500304-0
hellmis@urologicum-duisburg.de
Facility: University of Toledo
Arlington, Ohio 43606
United States
Status: Recruiting Contact: Contact
Amandine Catot
+49 201 723 3213
viktor.gruenwald@uk-essen.de
Facility: Oncology Hematology Care
Cincinnati, Ohio 45242
United States
Status: Recruiting Contact: Principal Investigator
Dirk Schrijvers
+49 2323 499 5252
florian.roghmann@elisabethgruppe.de
Facility: Cleveland Clinic
Cleveland, Ohio 44195
United States
Status: Recruiting Contact: Contact
Anne-Marie Salumu Ekendji
+49 30 450 616 187
maria.de-santis@charite.de
Facility: The Ohio State University College of Medicine
Columbus, Ohio 43210
United States
Status: Recruiting Contact: Principal Investigator
Bertrand Tombal
+49 68 41 16 24 777
julia.heinzelbecker@uks.eu
Facility: The University of Toledo Medical Center
Toledo, Ohio 43614
United States
Status: Recruiting Contact: Contact
Tammy Hale
+49 391 67 15 034
andreas.janitzky@med.ovgu.de
Facility: Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact: Principal Investigator
Scott North
+49 941 782 3510
mschnabel@cartasstijosef.de
Facility: Urology Associates
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: Contact
Lyn Lorenzen
+49 707 129 86 613
arnulf.stenzl@med.uni-tubingen.de
Facility: Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas 75390
United States
Status: Recruiting Contact: Contact
Srikala Sridhar
+34 91 336 80 00
pgajate@oncologiahrc.com
Facility: Bayor College of Medicine
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Dianna Leroux
+34915183232
javier.puente@salud.madrid.org
Facility: Houston Methodist Hospital- Department of Urology
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Lyn Lorenzen
+34913303182
cdanicas@hotmail.com
Facility: The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Principal Investigator
Bernhard J Eigl
+34 914603310
alvaropintomarin@gmail.com
Facility: UT Southwestern
Richardson, Texas 75080
United States
Status: Recruiting Contact: Contact
Robert Anais
+34 91 727 70 50
esevillano@hmhospitales.com
Facility: Urology San Antonio
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Estelle Thiot
+34 91 7277118
bpvalderrama@gmail.com
Facility: Huntsman Cancer Institute and Hospital
Salt Lake City, Utah 84112
United States
Status: Recruiting Contact: Contact
Anika Biniszkiewicz
+34917500193
Facility: Seattle Cancer Care Alliance
Seattle, Washington 98109
United States
Status: Recruiting Contact: Contact
Maria De Santis, PD MD
+34954232992
Facility: West Virginia University
Morgantown, West Virginia 26506
United States
Status: Recruiting Contact: Principal Investigator
Claudia Kleinfeld

Facility: CHU de Liège - Sart Tilman
Liège, Liège/Belgium 4000
Belgium
Status: Recruiting Contact: Contact
Micaela Löbert

Facility: ZNA Middelheim
Antwerpen, Alberta 1200
Belgium
Status: Recruiting Contact: Contact
Ayleen Bartels

Facility: Cliniques Universitaires Saint-Luc
Brussel, British Columbia T6G 1Z2
Belgium
Status: Recruiting Contact: Contact
Anika Biniszkiewicz

Facility: Universitair Ziekenhuis Leuven
Leuven, Ontario V5Z 4E6
Belgium
Status: Recruiting Contact: Contact
Maria De Santis

Facility: University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Pleven, Quebec M5G2M9
Bulgaria
Status: Recruiting Contact: Principal Investigator
Guenter Niegisch

Facility: Multiprofile Hospital For Active Treatment "Sveta Sofia"
Sofia, Ile-de-France H4A 3J1
Bulgaria
Status: Recruiting Contact: Principal Investigator
Tanja Lauer

Facility: Cross Cancer Institute
Edmonton, Ile-de-France G1R 2J6
Canada
Status: Recruiting Contact: Contact
Julia Heinzelbecker

Facility: BC Cancer- Vancouver
Vancouver, Paris/France 75013
Canada
Status: Recruiting Contact: Principal Investigator
Simone Nitschke

Facility: Princess Margaret Cancer Centre
Toronto, Rhone-Alpes 75015
Canada
Status: Recruiting Contact: Contact
Andreas Janitzky

Facility: McGill University Health Centre (MUHC)
Montréal, Strasbourg/France 75018
Canada
Status: Recruiting Contact: Principal Investigator
Kathrin Hese

Facility: CHU de Québec Université Laval
Québec, Toulouse/France 69008
Canada
Status: Recruiting Contact: Contact
Beatrice Welte

Facility: BC Cancer - Vancouver
Vancouver, Villejuif/France 67200
Canada
Status: Recruiting Contact: Contact
Amulf Stenzl

Facility: Hôpital Universitaire Pitié Salpêtrière
Paris, Berlin/Germany 31059
France
Status: Recruiting Contact: Principal Investigator
Daniel G. Palos

Facility: Hôpital Européen Georges-Pompidou
Paris, Nordrhein-Westfalen 94805
France
Status: Recruiting Contact: Contact
Ines de Cardenas

Facility: CHU de Nantes Hopital Hotel Dieu
Paris, Nordrhein-WestFalen 35760
France
Status: Recruiting Contact: Contact
Jonathan Lucas

Facility: Centre de Lutte Contre le Cancer - Centre Léon Bérard
Lyon, Nordrhein-Westfalen 10117
France
Status: Recruiting Contact: Contact
Susana Feliu

Facility: Institut de Cancerologie Strasbourg Europe
Strasbourg, Nordrhein-Westfalen 40225
France
Status: Recruiting Contact: Contact
Patricia Morgades

Facility: Institut Claudius Regaud
Toulouse, Cremona/Italy 47179
France
Status: Recruiting Contact: Contact
Elena Sevillano Fernandez

Facility: Gustave Roussy
Villejuif, Genova/Italy 45147
France
Status: Recruiting Contact: Contact
Cristina De Silva

Facility: CHU de Nantes Hopital Hotel Dieu
Nantes, Meldola/Italy 44625
France
Status: Recruiting Contact: Contact
Deborah Enting

Facility: Hopital Bichat - Claude - Bernard
Paris, Milano/Italy 93053
France
Status: Recruiting Contact: Principal Investigator


Facility: Centre Hospitalier Privé Saint-Grégoire
Saint-Grégoire, Naples 26100
France
Status: Recruiting Contact: Contact


Facility: Institut De Cancerologie De L'ouest - Site Saint-Herblain
Saint-Herblain, Pisa/italy 16132
France
Status: Recruiting Contact: Principal Investigator


Facility: Gustave Roussy
Villejuif, Potenza 47014
France
Status: Recruiting Contact: N/A
Facility: Charité - Universitatsmedizin Berlin
Berlin, Reggio Emilia/Italy 20141
Germany
Status: Recruiting Contact: N/A
Facility: Universitätsklinikum Düsseldorf
Duesseldorf, Roma/Italy 80131
Germany
Status: Recruiting Contact: N/A
Facility: Urologicum Duisburg
Duisburg, Torino 56126
Germany
Status: Recruiting Contact: N/A
Facility: Universitätsklinikum Essen
Essen, Trentino 85028
Germany
Status: Recruiting Contact: N/A
Facility: Marien Hospital Herne - Universitätsklinikum der Ruhr-Universität Bochum
Herne, Gelderland 42100
Germany
Status: Recruiting Contact: N/A
Facility: Charite Universitaetsmedizin Berlin
Berlin, Barcelona/Spain 00128
Germany
Status: Recruiting Contact: N/A
Facility: Urologie
Berlin, Barcelona/Spain 10043
Germany
Status: Recruiting Contact: N/A
Facility: University Hospital Duesseldorf
Duesseldorf, Barcelona/Spain 38100
Germany
Status: Recruiting Contact: N/A
Facility: Universitatsklinikum des Saarlandes Klinik fur Urologie & Kinderurologie
Homburg/saar, Barcelona 70124
Germany
Status: Recruiting Contact: N/A
Facility: Universitätsklinikum des Saarlandes Klinik für Urologie & Kinderurologie
Homburg, Barcelona 6532 SZ
Germany
Status: Recruiting Contact: N/A
Facility: Universitatsklinikum Magdeburg
Magdeburg, Córdoba/Spain 08003
Germany
Status: Recruiting Contact: N/A
Facility: Caritas-Krankenhaus St. Josef Klinik für Urologie
Regensburg, Girona/Spain 08041
Germany
Status: Recruiting Contact: N/A
Facility: Universitätsklinikum Tübingen
Tübingen, Madrid/Spain 08908
Germany
Status: Recruiting Contact: N/A
Facility: Ospedale di Cremona
Cremona, Madrid/Spain 08916
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale Policlinico San Martino
Genova, Madrid/Spain 08208
Italy
Status: Recruiting Contact: N/A
Facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Madrid/Spain 14004
Italy
Status: Recruiting Contact: N/A
Facility: Istituto Europeo di Oncologia
Milano, Madrid/Spain 17007
Italy
Status: Recruiting Contact: N/A
Facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Napoli, Madrid/Spain 28033
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliero-Universitaria Pisana
Pisa, Sevilla/Spain 28034
Italy
Status: Recruiting Contact: N/A
Facility: IRCCS Centro di Riferimento Oncologico di Basilicata
Rionero In Vulture, Toledo/Spain 28040
Italy
Status: Recruiting Contact: N/A
Facility: Arcispedale Santa Maria Nuova
Reggio Emilia, València 28041
Italy
Status: Recruiting Contact: N/A
Facility: Università Campus Bio-Medico di Roma
Roma, 28046
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano, 28050
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale di Trento - Presidio Ospedaliero Santa Chiara
Trento, 41013
Italy
Status: Recruiting Contact: N/A
Facility: Centro di Riferimento Oncologico
Aviano, 45005
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari
Bari, 46009
Italy
Status: Recruiting Contact: N/A
Facility: A.O.U.C. Polclinico di Bari U.O. Oncologia Medica Universitaria
Bari,
Italy
Status: Recruiting Contact: N/A
Facility: ASST Cremona
Casalmaggiore,
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale Policlinico San Martino Irccs
Genova,
Italy
Status: Recruiting Contact: N/A
Facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola,
Italy
Status: Recruiting Contact: N/A
Facility: Fondazione IRCCS INT Milano
Milan,
Italy
Status: Recruiting Contact: N/A
Facility: Istituto Europeo di Oncologia
Milan,
Italy
Status: Recruiting Contact: N/A
Facility: Int Pascale Napoli
Napoli,
Italy
Status: Recruiting Contact: N/A
Facility: AOU San Luigi Gonzaga
Orbassano,
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliero-Universitaria Pisana
Pisa,
Italy
Status: Recruiting Contact: N/A
Facility: IRCCS di Reggio Emilia
Reggio Emilia,
Italy
Status: Recruiting Contact: N/A
Facility: Policlinico Universitario Campus Biomedico
Roma,
Italy
Status: Recruiting Contact: N/A
Facility: Citta Della Salute e Della Scienz - Torino
Torino,
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale di Trento - Presidio Ospedaliero Santa Chiara
Trento,
Italy
Status: Recruiting Contact: N/A
Facility: IRCCS Centro di Riferimento Oncologico di Basilicata
Volterra,
Italy
Status: Recruiting Contact: N/A
Facility: Canisius-Wilhelmina Ziekenhuis
Nijmegen,
Netherlands
Status: Recruiting Contact: N/A
Facility: The Netherlands Cancer Institute
Amsterdam,
Netherlands
Status: Recruiting Contact: N/A
Facility: Zuyderland MC locatie Sittard
Geleen,
Netherlands
Status: Recruiting Contact: N/A
Facility: VHIO
Barcelona,
Spain
Status: Recruiting Contact: N/A
Facility: Sofia
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: Althaia Xarxa Assistencial Universitària de Manresa
Manresa,
Spain
Status: Recruiting Contact: N/A
Facility: Guy's and St Thomas' NHS Foundation Trust
London,
United Kingdom
Status: Recruiting Contact: N/A
Facility: Lister Hospital
Stevenage,
United Kingdom
Status: Recruiting Contact: N/A