Clinical trial NCT04197986: Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Upper Tract Urothelial Carcinomas
Urothelial Bladder Cancer
Keywords: FGFR3 Genetic Alterations
Upper Tract Urothelial Carcinomas
UTUC
Muscle Invasive Urothelial Carcinoma
Fibroblast Growth Factor Receptor Inhibitor
BGJ398
FGFR3
Urothelial Bladder Cancer
UBC
Infigratinib Phosphate
Infigratinib
Adjuvant
Nephroureterectomy
Distal ureterectomy
Cystectomy
Lead sponsor: QED Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Helsinn Healthcare SA
First posted: 2019-12-13
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned (1:1) to receive oral infigratinib phosphate or placebo
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria

1. Are randomized within 120 days following nephroureterectomy, distal ureterectomy or cystectomy.
2. 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).

   1. 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).
   2. 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.
   3. If not status post neoadjuvant chemotherapy, is ineligible to receive cisplatin-based adjuvant chemotherapy based on Galsky criteria:
   4. 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:
   5. 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.
3. Have Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
4. 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:

1. 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.
2. Have received Bacillus Calmette-Guerin (BCG) or other intravesical therapy for Non-Muscle Invasive Bladder Cancer (NMIBC) within the previous 30 days.
3. 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:

   1. Prior adjuvant treatment for urothelial cancer is not allowed.
   2. 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.
   3. 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.
4. Have previously or currently is receiving treatment with a mitogen-activated protein kinase (MEK) or selective FGFR inhibitor.
5. 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.
6. 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.
7. Have a history and/or current evidence of extensive tissue calcification
8. Have impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib
9. Have current evidence of endocrine alterations of calcium/phosphate homeostasis (eg, parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis), unless well controlled.
10. 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.
11. Have insufficient bone marrow function:

    1. Absolute neutrophil count (ANC) \<1,000/mm3 (1.0 × 109/L).
    2. Platelets \<75,000/mm3 (\<75 × 109/L).
    3. Hemoglobin \<8.5 g/dL; transfusion support is allowed if \>1 week before randomization and hemoglobin remains stable.
12. Have insufficient hepatic and renal function:

    1. 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).
    2. AST/SGOT and ALT/SGPT \>2.5 × ULN of the testing laboratory.
    3. Serum creatinine \>1.5 × ULN or a calculated or measured creatinine clearance of \<30 mL/min.
13. Have amylase or lipase \>2.0 × ULN.
14. Have abnormal calcium or phosphorus:

    1. Inorganic phosphorus higher than 1.02 × ULN of the testing laboratory.
    2. Total serum calcium (can be corrected) higher than 1.02 × ULN of the testing laboratory.
15. Have clinically significant cardiac disease including any of the following:

    1. 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.
    2. Uncontrolled hypertension
    3. Presence of CTCAE v5.0 Grade ≥2 ventricular arrhythmias, atrial fibrillation, bradycardia, or conduction abnormality.
    4. Unstable angina pectoris or acute myocardial infarction ≤3 months before the first dose of study drug.
    5. 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.
    6. History of congenital long QT syndrome.
16. Have had a recent (≤3 months before the first dose of study drug) transient ischemic attack or stroke.
17. If female, are pregnant or nursing (lactating).

Primary outcomes:
measure: Centrally Determined Disease-free Survival (DFS)
timeFrame: The number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause.
Secondary outcomes:
measure: Investigator-assessed DFS
timeFrame: The number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause.
measure: Metastasis-free Survival (MFS)
timeFrame: The time from randomization to any metastatic recurrence as determined by the investigator, or death due to any cause.
measure: Overall Survival (OS)
timeFrame: The number of months from randomization to death.
measure: Investigator-reviewed DFS Including Intraluminal Low-Risk Recurrence
timeFrame: The number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause.
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From first dose to last dose of study treatment +30 days (an average of 4 months for the infigratinib arm and 8 months for the placebo arm).
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From first dose to last dose of study treatment +30 days (an average of 4 months for the infigratinib arm and 8 months for the placebo arm)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Duarte
country: United States
facility: City of Hope - Duarte
state: California
city: Duarte
country: United States
facility: City of Hope
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Faculty Medical Clinics
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Hialeah
country: United States
facility: Urological Research Network CORP
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Health Hollis Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: UChicago Medicine Duchossois Center for Advanced Medicine (DCAM) - Hyde Park
state: Illinois
city: Lisle
country: United States
facility: DuPage Medical Group - Warrenville Road
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
city: New Orleans
country: United States
facility: Tulane University/Southeastern Louisiana VA Health Care
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Saint Louis
country: United States
facility: Saint Louis University- SLUCare Academic Pavilion
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Saddle Brook
country: United States
facility: New Jersey Urology - Saddle Brook
state: New Jersey
city: Voorhees
country: United States
facility: New Jersey Urology
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center - Division of Urology
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals - Syracuse
state: New York
city: Durham
country: United States
facility: Duke University Cancer Center
state: North Carolina
city: Raleigh
country: United States
facility: Accellacare-DuPage Medical Group
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Arlington
country: United States
facility: University of Toledo
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University College of Medicine
state: Ohio
city: Toledo
country: United States
facility: The University of Toledo Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates
state: Tennessee
city: Dallas
country: United States
facility: Harold C. Simmons Comprehensive Cancer Center
state: Texas
city: Houston
country: United States
facility: Bayor College of Medicine
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital- Department of Urology
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Richardson
country: United States
facility: UT Southwestern
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute and Hospital
state: Utah
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Liège
country: Belgium
facility: CHU de Liège - Sart Tilman
state: Liège/Belgium
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Brussel
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Burgas
country: Bulgaria
facility: University Multiprofile Hospital For Active Treatment Deva Maria
city: Pleven
country: Bulgaria
facility: University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment "Sveta Sofia"
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: BC Cancer- Vancouver
state: British Columbia
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Centre (MUHC)
state: Quebec
city: Québec
country: Canada
facility: CHU de Québec Université Laval
city: Vancouver
country: Canada
facility: BC Cancer - Vancouver
city: Paris
country: France
facility: Hôpital Universitaire Pitié Salpêtrière
state: Ile-de-France
city: Paris
country: France
facility: Hôpital Européen Georges-Pompidou
state: Ile-de-France
city: Paris
country: France
facility: CHU de Nantes Hopital Hotel Dieu
state: Paris/France
city: Lyon
country: France
facility: Centre de Lutte Contre le Cancer - Centre Léon Bérard
state: Rhone-Alpes
city: Strasbourg
country: France
facility: Institut de Cancerologie Strasbourg Europe
state: Strasbourg/France
city: Toulouse
country: France
facility: Institut Claudius Regaud
state: Toulouse/France
city: Villejuif
country: France
facility: Gustave Roussy
state: Villejuif/France
city: Brest
country: France
facility: Hôpital Morvan
city: Nantes
country: France
facility: CHU de Nantes Hopital Hotel Dieu
city: Paris
country: France
facility: Hopital Bichat - Claude - Bernard
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint-Grégoire
country: France
facility: Centre Hospitalier Privé Saint-Grégoire
city: Saint-Herblain
country: France
facility: Institut De Cancerologie De L'ouest - Site Saint-Herblain
city: Saint-Nazaire
country: France
facility: Clinique Mutualiste de l'Estuaire
city: Villejuif
country: France
facility: Gustave Roussy
city: Berlin
country: Germany
facility: Charité - Universitatsmedizin Berlin
state: Berlin/Germany
city: Duesseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
state: Nordrhein-Westfalen
city: Duisburg
country: Germany
facility: Urologicum Duisburg
state: Nordrhein-WestFalen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
state: Nordrhein-Westfalen
city: Herne
country: Germany
facility: Marien Hospital Herne - Universitätsklinikum der Ruhr-Universität Bochum
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin
city: Berlin
country: Germany
facility: Urologie
city: Duesseldorf
country: Germany
facility: University Hospital Duesseldorf
city: Homburg/saar
country: Germany
facility: Universitatsklinikum des Saarlandes Klinik fur Urologie & Kinderurologie
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes Klinik für Urologie & Kinderurologie
city: Magdeburg
country: Germany
facility: Universitatsklinikum Magdeburg
city: Regensburg
country: Germany
facility: Caritas-Krankenhaus St. Josef Klinik für Urologie
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Athens
country: Greece
facility: Henry Dunant Hospital Center
state: Attica
city: Thessaloníki
country: Greece
facility: Bioclinic Thessalonikis
state: Makedonia
city: Volos
country: Greece
facility: Anassa General Clinic
city: Cremona
country: Italy
facility: Ospedale di Cremona
state: Cremona/Italy
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
state: Genova/Italy
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
state: Meldola/Italy
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
state: Milano/Italy
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
state: Naples
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
state: Pisa/italy
city: Rionero In Vulture
country: Italy
facility: IRCCS Centro di Riferimento Oncologico di Basilicata
state: Potenza
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
state: Reggio Emilia/Italy
city: Roma
country: Italy
facility: Università Campus Bio-Medico di Roma
state: Roma/Italy
city: Orbassano
country: Italy
facility: Azienda Ospedaliero - Universitaria San Luigi Gonzaga
state: Torino
city: Trento
country: Italy
facility: Ospedale di Trento - Presidio Ospedaliero Santa Chiara
state: Trentino
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico
city: Bari
country: Italy
facility: Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari
city: Bari
country: Italy
facility: A.O.U.C. Polclinico di Bari U.O. Oncologia Medica Universitaria
city: Casalmaggiore
country: Italy
facility: ASST Cremona
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino Irccs
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
city: Milan
country: Italy
facility: Fondazione IRCCS INT Milano
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia
city: Napoli
country: Italy
facility: Int Pascale Napoli
city: Orbassano
country: Italy
facility: AOU San Luigi Gonzaga
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
city: Reggio Emilia
country: Italy
facility: IRCCS di Reggio Emilia
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico
city: Torino
country: Italy
facility: Citta Della Salute e Della Scienz - Torino
city: Trento
country: Italy
facility: Ospedale di Trento - Presidio Ospedaliero Santa Chiara
city: Volterra
country: Italy
facility: IRCCS Centro di Riferimento Oncologico di Basilicata
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis
state: Gelderland
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute
city: Geleen
country: Netherlands
facility: Zuyderland MC locatie Sittard
city: Barcelona
country: Spain
facility: VHIO
state: Barcelona/Spain
city: Barcelona
country: Spain
facility: Sofia
state: Barcelona/Spain
city: Barcelona
country: Spain
facility: Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
state: Barcelona/Spain
city: Badalona
country: Spain
facility: Institut Català d'Oncologia Badalona
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Parc Taulí de Sabadell
state: Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
state: Córdoba/Spain
city: Girona
country: Spain
facility: Institut Català d'Oncologia Girona
state: Girona/Spain
city: Madrid
country: Spain
facility: MD Anderson Cancer Center Madrid
state: Madrid/Spain
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
state: Madrid/Spain
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
state: Madrid/Spain
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
state: Madrid/Spain
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
state: Madrid/Spain
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
state: Madrid/Spain
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta Hierro-Majadahonda
state: Madrid
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
state: Sevilla/Spain
city: Toledo
country: Spain
facility: Hospital Virgen De La Salud
state: Toledo/Spain
city: Valencia
country: Spain
facility: Fundacion Instituto Valenciano de Oncologia
state: València
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Manresa
country: Spain
facility: Althaia Xarxa Assistencial Universitària de Manresa
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: Stevenage
country: United Kingdom
facility: Lister Hospital
Study officials:
affiliation: QED Therapeutics, Inc.
name: David van Veenhuyzen, M.B., Ch.B., M.Pharm.Med.
role: STUDY_DIRECTOR
References:
citation: Pal SK, Somford DM, Grivas P, Sridhar SS, Gupta S, Bellmunt J, Sonpavde G, Fleming MT, Lerner SP, Loriot Y, Hoffman-Censits J, Valderrama BP, Andresen C, Schnabel MJ, Cole S, Daneshmand S. Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial. Future Oncol. 2022 Jul;18(21):2599-2614. doi: 10.2217/fon-2021-1629. Epub 2022 May 24.