AzTrials
AzTrials

Upper Tract Urothelial CarcinomasPhase 3PROOF302NCT04197986

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

A Phase 3 study testing Infigratinib in people with Upper Tract Urothelial Carcinomas and Urothelial Bladder Cancer, run by QED Therapeutics, a BridgeBio company at 143 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Infigratinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
143 sitesin 11 countries
Study dates
11 Mar 2020to 28 Feb 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 18Show fewer
  • 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

Who cannot join

  • 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.
Show all 34Show fewer
  • 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).

Trial locations and contacts

143 sites in 11 countries.

143 sites in 11 countries

United States47 sites

  • Albany Medical Center - Division of Urology

    Albany, New York, 12208

  • University of Toledo

    Arlington, Ohio, 43606

  • Emory University

    Atlanta, Georgia, 30322

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • UChicago Medicine Duchossois Center for Advanced Medicine (DCAM) - Hyde Park

    Chicago, Illinois, 60637

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University College of Medicine

    Columbus, Ohio, 43210

  • Harold C. Simmons Comprehensive Cancer Center

    Dallas, Texas, 75390

  • The Urology Center of Colorado

    Denver, Colorado, 80211

  • City of Hope - Duarte

    Duarte, California, 91010

  • City of Hope

    Duarte, California, 91010

  • Duke University Cancer Center

    Durham, North Carolina, 27710

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Urological Research Network CORP

    Hialeah, Florida, 33016

  • Bayor College of Medicine

    Houston, Texas, 77030

  • Houston Methodist Hospital- Department of Urology

    Houston, Texas, 77030

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Lakeland Regional Health Hollis Cancer Center

    Lakeland, Florida, 33805

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

  • DuPage Medical Group - Warrenville Road

    Lisle, Illinois, 60532

  • Loma Linda University Faculty Medical Clinics

    Loma Linda, California, 92350

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Urology Associates

    Nashville, Tennessee, 37209

  • Tulane University/Southeastern Louisiana VA Health Care

    New Orleans, Louisiana, 70112

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Accellacare-DuPage Medical Group

    Raleigh, North Carolina, 27609

  • UT Southwestern

    Richardson, Texas, 75080

  • New Jersey Urology - Saddle Brook

    Saddle Brook, New Jersey, 07663

  • Huntsman Cancer Institute and Hospital

    Salt Lake City, Utah, 84112

  • Urology San Antonio

    San Antonio, Texas, 78229

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Saint Louis University- SLUCare Academic Pavilion

    St Louis, Missouri, 63110

  • Associated Medical Professionals - Syracuse

    Syracuse, New York, 13210

  • The University of Toledo Medical Center

    Toledo, Ohio, 43614

  • Arizona Oncology Associates

    Tucson, Arizona, 85711

  • New Jersey Urology

    Voorhees Township, New Jersey, 08043

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

Italy27 sites

  • Centro di Riferimento Oncologico

    Aviano

  • Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari

    Bari, 70124

  • A.O.U.C. Polclinico di Bari U.O. Oncologia Medica Universitaria

    Bari

  • ASST Cremona

    Casalmaggiore

  • Ospedale di Cremona

    Cremona, Cremona/Italy, 26100

  • Ospedale Policlinico San Martino

    Genova, Genova/Italy, 16132

  • Ospedale Policlinico San Martino Irccs

    Genova

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, Meldola/Italy, 47014

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola

  • Istituto Europeo di Oncologia

    Milan, Milano/Italy, 20141

  • Fondazione IRCCS INT Milano

    Milan

  • Istituto Europeo di Oncologia

    Milan

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Naples, Naples, 80131

  • Int Pascale Napoli

    Naples

  • Azienda Ospedaliero - Universitaria San Luigi Gonzaga

    Orbassano, Torino, 10043

  • AOU San Luigi Gonzaga

    Orbassano

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, Pisa/italy, 56126

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, Reggio Emilia/Italy, 42100

  • IRCCS di Reggio Emilia

    Reggio Emilia

  • IRCCS Centro di Riferimento Oncologico di Basilicata

    Rionero in Vulture, Potenza, 85028

  • Università Campus Bio-Medico di Roma

    Roma, Roma/Italy, 00128

  • Policlinico Universitario Campus Biomedico

    Roma

  • Citta Della Salute e Della Scienz - Torino

    Torino

  • Ospedale di Trento - Presidio Ospedaliero Santa Chiara

    Trento, Trentino-Alto Adige, 38100

  • Ospedale di Trento - Presidio Ospedaliero Santa Chiara

    Trento

  • IRCCS Centro di Riferimento Oncologico di Basilicata

    Volterra

Other trials in Italy

Spain20 sites

  • Institut Català d'Oncologia Badalona

    Badalona, Barcelona, 08916

  • VHIO

    Barcelona, Barcelona/Spain, 08003

  • Sofia

    Barcelona, Barcelona/Spain, 08041

  • Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

    Barcelona, Barcelona/Spain, 08908

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Universitario Reina Sofía

    Córdoba, Córdoba/Spain, 14004

  • Institut Català d'Oncologia Girona

    Girona, Girona/Spain, 17007

  • MD Anderson Cancer Center Madrid

    Madrid, Madrid/Spain, 28033

  • Hospital Universitario Ramon y Cajal

    Madrid, Madrid/Spain, 28034

  • Hospital Clinico San Carlos

    Madrid, Madrid/Spain, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid/Spain, 28041

  • Hospital Universitario La Paz

    Madrid, Madrid/Spain, 28046

  • Hospital Universitario HM Sanchinarro

    Madrid, Madrid/Spain, 28050

  • Hospital Universitario Puerta Hierro-Majadahonda

    Majadahonda, Madrid, 28222

  • Althaia Xarxa Assistencial Universitària de Manresa

    Manresa

  • Hospital Parc Taulí de Sabadell

    Sabadell, Barcelona, 08208

  • Hospital Universitario Virgen del Rocio

    Seville, Sevilla/Spain, 41013

  • Hospital Virgen De La Salud

    Toledo, Toledo/Spain, 45005

  • Fundacion Instituto Valenciano de Oncologia

    Valencia, València, 46009

Other trials in Spain

France15 sites

  • Hôpital Morvan

    Brest, 29200

  • Centre de Lutte Contre le Cancer - Centre Léon Bérard

    Lyon, Auvergne-Rhône-Alpes, 69008

  • CHU de Nantes Hopital Hotel Dieu

    Nantes

  • CHU de Nantes Hopital Hotel Dieu

    Paris, Paris/France, 75018

  • Hopital Bichat - Claude - Bernard

    Paris

  • Hôpital Universitaire Pitié Salpêtrière

    Paris, Île-de-France Region, 75013

  • Hôpital Européen Georges-Pompidou

    Paris, Île-de-France Region, 75015

  • Centre Eugène Marquis

    Rennes, 35042

  • Centre Hospitalier Privé Saint-Grégoire

    Saint-Grégoire, 35760

  • Institut De Cancerologie De L'ouest - Site Saint-Herblain

    Saint-Herblain

  • Clinique Mutualiste de l'Estuaire

    Saint-Nazaire, 44600

  • Institut de Cancerologie Strasbourg Europe

    Strasbourg, Strasbourg/France, 67200

  • Institut Claudius Regaud

    Toulouse, Toulouse/France, 31059

  • Gustave Roussy

    Villejuif, Villejuif/France, 94805

  • Gustave Roussy

    Villejuif

Other trials in France

Germany13 sites

  • Charité - Universitatsmedizin Berlin

    Berlin, Berlin/Germany, 10117

  • Charite Universitaetsmedizin Berlin

    Berlin

  • Urologie

    Berlin

  • Urologicum Duisburg

    Duisburg, North Rhine-Westphalia, 47179

  • Universitätsklinikum Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40225

  • University Hospital Duesseldorf

    Düsseldorf

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

  • Marien Hospital Herne - Universitätsklinikum der Ruhr-Universität Bochum

    Herne, North Rhine-Westphalia, 44625

  • Universitätsklinikum des Saarlandes Klinik für Urologie & Kinderurologie

    Homburg

  • Universitatsklinikum des Saarlandes Klinik fur Urologie & Kinderurologie

    Homburg/saar

  • Universitatsklinikum Magdeburg

    Magdeburg

  • Caritas-Krankenhaus St. Josef Klinik für Urologie

    Regensburg, 93053

  • Universitätsklinikum Tübingen

    Tübingen

Other trials in Germany

Canada6 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A 3J1

  • CHU de Québec Université Laval

    Québec, G1R 2J6

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G2M9

  • BC Cancer- Vancouver

    Vancouver, British Columbia, V5Z 4E6

  • BC Cancer - Vancouver

    Vancouver

Other trials in Canada

Belgium4 sites

  • ZNA Middelheim

    Antwerp

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Leuven

    Leuven

  • CHU de Liège - Sart Tilman

    Liège, Liège/Belgium, 4000

Other trials in Belgium

Bulgaria3 sites

  • University Multiprofile Hospital For Active Treatment Deva Maria

    Burgas, 8001

  • University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD

    Pleven

  • Multiprofile Hospital For Active Treatment "Sveta Sofia"

    Sofia

Other trials in Bulgaria

Greece3 sites

  • Henry Dunant Hospital Center

    Athens, Attica, 11526

  • Bioclinic Thessalonikis

    Thessaloniki, Makedonia, 54622

  • Anassa General Clinic

    Volos

Other trials in Greece

Netherlands3 sites

  • The Netherlands Cancer Institute

    Amsterdam

  • Zuyderland MC locatie Sittard

    Geleen

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, Gelderland, 6532 SZ

Other trials in Netherlands

United Kingdom2 sites

  • Guy's and St Thomas' NHS Foundation Trust

    London

  • Lister Hospital

    Stevenage

Other trials in United Kingdom

About this study

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)

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.

Being tested
Infigratinib, Placebo
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InfigratinibDrug

    Also called IP, Study drug

    Participants randomly assigned to infigratinib will receive hard gelatin capsules for oral administration of infigratinib 125 mg once a day (administered as one 100-mg capsule and one 25-mg capsule) using a 3 weeks on (Days 1-21) /1 week off (Days 22-28) dosing schedule.

  • PlaceboDrug

    Participants randomly assigned to placebo will receive placebo matching in appearance the investigational product (infigratinib), which will be provided as hard gelatin capsules for oral use and will be administered once daily on a 3 weeks on (Days 1-21) /1 week off (Days 22-28) dosing schedule.

Study groups in NCT04197986
Study groupRoleWhat they receive
Infigratinib 125 mgExperimentalParticipants will be randomly assigned (1:1) to receive oral infigratinib administered once daily for the first 3 weeks (21 days) of each 28-day cycle for a maximum of 52 weeks
Receives: Drug: Infigratinib
PlaceboPlacebo comparatorParticipants will be randomly assigned (1:1) to receive oral placebo administered once daily for the first 3 weeks (21 days) of each 28-day cycle for a maximum of 52 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Centrally Determined Disease-free Survival (DFS)

    DFS was defined as the number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause (referred as DFS event), whichever occurs earlier.

    Due to early termination of the study by the sponsor, results will focus primarily on the primary and key secondary endpoints of the study. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023.

    Measured: The number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause.

Secondary outcomes (6)

  1. Investigator-assessed DFS

    DFS was defined as the number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause (referred as DFS event), whichever occurs earlier. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023.

    Measured: The number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause.

  2. Metastasis-free Survival (MFS)

    MFS was defined as the time from randomization to any metastatic recurrence as determined by the investigator, or death due to any cause, whichever occurred earlier. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023.

    Measured: The time from randomization to any metastatic recurrence as determined by the investigator, or death due to any cause.

  3. Overall Survival (OS)

    Overall survival time was defined as the number of months from randomization to death. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023.

    Measured: The number of months from randomization to death.

  4. Investigator-reviewed DFS Including Intraluminal Low-Risk Recurrence

    Investigator assessment of intraluminal low-risk recurrence as assessed by DFS. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023.

    Measured: The number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause.

  5. Number of Participants With Adverse Events (AEs)

    Number of participants with AEs

    Measured: 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).

  6. Number of Participants With Serious Adverse Events (SAEs)

    Number of Participants with SAEs

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2019
  2. Study start11 Mar 2020
  3. Primary completion28 Feb 2023
  4. Study completion28 Feb 2023

Why it stopped: The sponsor has decided to close the study due to the discontinuation of infigratinib development. The discontinuation of the study was not due to safety reasons.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned (1:1) to receive oral infigratinib phosphate or placebo
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04197986
Sponsor's protocol ID
QBGJ398-302
Other IDs
2019-003248-63, 2019
Acronym
PROOF302
Status last verified
Feb 2024
First submitted
2 Dec 2019
Last updated
13 Mar 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Szymaniak J, Porten SP. Which Biomarkers are Useful in the Management of Muscle-invasive Bladder Cancer in 2022? Eur Urol Focus. 2022 Jul;8(4):901-903. doi: 10.1016/j.euf.2022.08.009. Epub 2022 Sep 2.

    PubMed 36058810

  • 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.

    PubMed 35608106

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Infigratinib in people with Upper Tract Urothelial Carcinomas and Urothelial Bladder Cancer, run by QED Therapeutics, a BridgeBio company at 143 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 143 sites in United States, Italy, Spain, France, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Centrally Determined Disease-free Survival (DFS) (time frame: The number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04197986, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.

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