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AzTrials

Carcinoma, Transitional CellPhase 2/3FORT-1NCT03410693

Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma

A Phase 2/3 study testing Rogaratinib (BAY1163877) and Chemotherapy in people with Carcinoma, Transitional Cell, run by Bayer at 161 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Transitional Cell
What is being tested?
Rogaratinib (BAY1163877) and Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
175 participants
Where
161 sitesin 29 countries
Study dates
31 May 2018to 27 Oct 2020
Phase
Phase 2/3
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

  • Existence of archival or fresh biopsy for FGFR testing. Mandatory FGFR testing of patients will be performed prior to start of screening. The timing of the FGFR test is at the discretion of the investigator. Investigators should ensure all patients will be eligible in terms of disease status and lines of treatment.
  • Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria
  • Histologically confirmed (Patients with mixed histologies are required to have a dominant transitional cell pattern.)
  • Locally advanced (T4, any N; or any T, N 2-3) or metastatic disease (any T, any N and M1). Locally advanced bladder cancer must be unresectable i.e. invading the pelvic or abdominal wall (stage T4b) or presenting with bulky nodal disease (N2-3).
  • ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 or 1
  • Disease progression during or following treatment with at least one platinum-containing regimen (patients should have been treated for at least 2 cycles). In patients who received prior adjuvant/ neoadjuvant platinum-containing chemotherapy, progression had to occur within 12 months of treatment.
  • High FGFR1 or 3 mRNA expression levels in archival or fresh tumor biopsy specimen quantified as outlined in the lab manual
  • At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) in contrast enhanced (unless contraindicated) CT or MRI

Who cannot join

  • Previous or concurrent cancer except
  • cervical carcinoma in situ
  • treated basal-cell or squamous cell skin carcinoma
  • any cancer curatively treated > 3 years before randomization
  • curatively treated incidental prostate cancer (T1/T2a)
  • Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFR-specific antibodies) or with taxanes or vinflunine
Show all 18Show fewer
  • More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma given for advanced unresectable/ metastatic disease
  • Ongoing or previous anti-cancer treatment within 4 weeks before randomization.
  • Unresolved toxicity higher than National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v.4.03) Grade 1 attributed to any prior therapy/ procedure excluding alopecia, anemia and/ or hypothyroidism
  • History or current condition of an uncontrolled cardiovascular disease including any of the following conditions:
  • Congestive heart failure (CHF) NYHA (New York Heart Association) > Class 2
  • Unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months before randomization)
  • Myocardial infarction (MI) within past 6 months before randomization
  • Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible.
  • Arterial or venous thrombotic events or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before randomization
  • Current evidence of endocrine alteration of calcium phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia)
  • Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion
  • Any hemorrhage / bleeding event ≥ CTCAE v.4.03 Grade 3 within 4 weeks before randomization

Trial locations and contacts

161 sites in 29 countries.

161 sites in 29 countries

Japan23 sites

  • Akita University Hospital

    Akita, 010-8543

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo, 113-8603

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Saitama Medical University International Medical Center

    Hidaka, Saitama, 350-1298

  • Hirosaki University Hospital

    Hirosaki, Aomori, 036-8563

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • The Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo, 135-8550

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511

  • Iwate Medical University Hospital

    Morioka, Iwate, 028-3695

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Niigata University Medical and Dental Hospital

    Niigata, 951-8520

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Gunma Prefectural Cancer Center

    Ōta, Gunma, 373-8550

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido, 060-8543

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Kindai University Hospital

    Sayama, Osaka, 589-8511

  • Keio University Hospital

    Shinjuku-ku, Tokyo, 160-8582

  • Toyama University Hospital

    Toyama, 930-0194

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

United States16 sites

  • Alaska Clinical Research Center, LLC

    Anchorage, Alaska, 99503

  • Texas Oncology-Denton South

    Denton, Texas, 76210

  • Bon Secours St. Francis Hospital

    Greenville, South Carolina, 29607

  • Houston Methodist Hospital

    Houston, Texas, 77030-2707

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Rocky Mountain Cancer Centers

    Littleton, Colorado, 80120-4413

  • University of Southern California

    Los Angeles, California, 90033

  • UF Cancer Center at Orlando Health

    Orlando, Florida, 32806

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15232

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Sansum Clinic

    Santa Barbara, California, 93105

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Summit Cancer Center

    Spokane, Washington, 99208

  • Compass Oncology

    Tigard, Oregon, 97223

  • University of Arizona Cancer Center

    Tucson, Arizona, 85719

  • University of Kansas Medical Center

    Westwood, Kansas, 66205

Other trials in United States

Spain12 sites

  • Institut Català d'Oncologia Badalona

    Badalona, Barcelona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Ciutat Sanitària i Universitaria de la Vall d'Hebron

    Barcelona, 08035

  • Hospital San Pedro de Alcántara

    Cáceres, 10003

  • Hospital Reina Sofía

    Córdoba, 14004

  • Institut Català d'Oncologia Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitari Son Espases

    Palma de Mallorca, Illes Baleares, 07120

  • Instituto Valenciano de Oncología

    Valencia, 46009

  • Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

France11 sites

  • Hopital Jean Minjoz

    Besançon, 25030

  • Hôpital Saint André - Bordeaux

    Bordeaux, 33000

  • Centre de Lutte Contre le Cancer François Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Oscar Lambret - Lille

    Lille, 59020

  • Centre Léon Bérard

    Lyon, 69008

  • Institut Paoli-Calmettes - Marseille

    Marseille, 13273

  • Cochin - Paris

    Paris, 75674

  • Hôpital d'Instruction des Armées Begin

    Saint-Mandé, 94160

  • Clinique Saint Anne

    Strasbourg, 67000

  • Centre Médico-Chirurgical Foch

    Suresnes, 92151

Other trials in France

Italy11 sites

  • IRST Istituto Scientifico Romagnolo per studio e cura tumori

    Forlì Cesena, Emilia-Romagna, 47014

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Lombardy, 20133

  • IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)

    Milan, Lombardy, 20141

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Lombardy, 20162

  • AUSL Modena

    Modena, Emilia-Romagna, 41012

  • A.O.U. di Modena - Policlinico

    Modena, Emilia-Romagna, 41124

  • A.O.U. Pisana

    Pisa, Tuscany, 56126

  • A.O. San Camillo-Forlanini

    Rome, Lazio, 00152

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168

  • A.O.U. San Luigi Gonzaga

    Turin, Piedmont, 10043

  • A.O.U.I. Verona

    Verona, Veneto, 37134

Other trials in Italy

China10 sites

  • Fifth Medical Center, General Hospital of the Chinese People

    Beijing, 100071

  • FuJian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • First Affiliated Hospital of Guangzhou Medical University

    Guangzhou

  • NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School

    Nanjing, Jiangsu, 210008

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Huadong Hospital, Affiliated to Fudan University

    Shanghai, 200040

  • Liaoning Cancer Hospital and Institute

    Shengyang, Liaoning, 110042

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

Other trials in China

Australia7 sites

  • Pindara Private Hospital

    Benowa, Queensland, 4217

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Mid North Coast Cancer Institute

    Coffs Harbour, New South Wales, 2450

  • Northern Cancer Institute

    St Leonards, New South Wales, 2065

  • Macquarie University Hospital

    Sydney, New South Wales, 2109

  • Riverina Cancer Care Centre

    Wagga Wagga, New South Wales, 2650

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076

Other trials in Australia

Poland6 sites

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka

    Bydgoszcz, 85-796

  • Swietokrzyskie Centrum Onkologii

    Kielce, 25-734

  • Przychodnia Lekarska KOMED

    Konin, 62-500

  • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc

    Olsztyn, 10-357

  • Szpital Kliniczny Przemienienia Panskiego

    Poznan, 60-569

  • Uniwersytecki Szpital Kliniczny UM we Wroclawiu

    Wroclaw, 50-556

Other trials in Poland

Israel5 sites

  • Rambam Health Corporation

    Haifa, 3109601

  • Hadassah Hebrew University Hospital Ein Kerem

    Jerusalem, 9112001

  • Meir Medical Center

    Kfar Saba, 4428164

  • Clalit Health Services Rabin Medical Center-Beilinson Campus

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center

    Ramat Gan, 5266202

Other trials in Israel

Portugal5 sites

  • IPO Coimbra

    Coimbra, 3000-075

  • Hospital CUF Infante Santo

    Lisbon, 1350-070

  • CHULN - Hospital Santa Maria

    Lisbon, 1649-035

  • Hospital Beatriz Angelo

    Loures, Lisbon District, 2674-514

  • Centro Hospitalar Universitario do Porto

    Porto, 4099-001

Other trials in Portugal

Russia5 sites

  • Krasnoyarsk Regional Clinical Oncology Dispensary

    Krasnoyarsk, 660133

  • Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen

    Moscow, 125284

  • Volga District Med Center FMBA

    Nizhny Novgorod, 603109

  • Clinical Oncological Dispensary of Omsk Region

    Omsk, 644013

  • Bashkir State Medical University

    Ufa, 450008

Other trials in Russia

Taiwan5 sites

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Memorial Hospital at Linkou

    Taoyuan, 33305

Other trials in Taiwan

Austria4 sites

  • Landesklinikum Krems

    Krems, 3500

  • Krankenhaus der Barmherzigen Brüder

    Vienna, 1020

  • Universitätsklinikum AKH Wien

    Vienna, 1090

  • Klinik Ottakring - Wilhelminenspital

    Vienna, 1160

Other trials in Austria

Czechia4 sites

  • Fakultni nemocnice Ostrava

    Ostrava, 708 52

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 10034

  • Fakultni Thomayerova Nemocnice

    Praha 4 - Krc, 140 59

  • Bata Hospital

    Zlín, 762 75

Other trials in Czechia

South Korea4 sites

  • National Cancer Center

    Goyang-si, Gyeonggido, 10408

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Belgium3 sites

  • UZ Gent

    Ghent, 9000

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • Clinique Saint-Pierre

    Ottignies, 1340

Other trials in Belgium

Canada3 sites

  • Sir Mortimer B. Davis Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Ottawa Hospital-General Campus

    Ottawa, K1H 8L6

  • Princess Margaret Hospital-University Health Network

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Denmark3 sites

  • Aarhus Universitetshospital, Skejby

    Aarhus N, 8200

  • Rigshospitalet

    Copenhagen, 2100

  • Herlev Hospital - Oncology Research Dept.

    Herlev, 2730

Other trials in Denmark

Germany3 sites

  • Heinrich-Heine-Universität Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40225

  • Universitätsmedizin der Johannes Gutenberg Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Eberhard-Karls-Universität Tübingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Hungary3 sites

  • MH Egeszsegugyi Kozpont

    Budapest, 1062

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7624

Other trials in Hungary

Slovakia3 sites

  • Narodny onkologicky ustav

    Bratislava, 833 10

  • UROEXAM, spol. s r.o.

    Nitra, 949 01

  • POKO Poprad s.r.o.

    Poprad, 085 01

Other trials in Slovakia

Switzerland3 sites

  • Universitätsspital Basel

    Basel, Canton of Basel-City, 4031

  • Kantonsspital Graubünden

    Chur, Kanton Graubünden, 7000

  • Kantonsspital St. Gallen

    Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

Ireland2 sites

  • Cork University Hospital

    Cork

  • AMNCH

    Dublin, 24

Other trials in Ireland

Netherlands2 sites

  • Nederlands Kanker Instituut

    Amsterdam, 1066 CX

  • Erasmus Medisch Centrum

    Rotterdam, 3075 EA

Other trials in Netherlands

Singapore2 sites

  • National University Hospital

    Singapore, 119074

  • National Cancer Center Singapore

    Singapore, 169610

Other trials in Singapore

Sweden2 sites

  • Södersjukhuset

    Stockholm, 118 83

  • Karolinska Institutet

    Stockholm, 17167

Other trials in Sweden

United Kingdom2 sites

  • Clatterbridge Centre for Oncology

    Bebington, Merseyside, CH63 4JY

  • Royal Marsden Hospital (London)

    London, SW3 6JJ

Other trials in United Kingdom

Finland1 site

  • Docrates Klinikka

    Helsinki, 00180

Other trials in Finland

Hong Kong1 site

  • Prince of Wales Hospital Hong Kong

    Shatin

Other trials in Hong Kong

About this study

Official title: A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy

This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy.

The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors.

At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.

Being tested
Rogaratinib (BAY1163877), Chemotherapy
Keywords
Urothelial carcinoma
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

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

  • Rogaratinib (BAY1163877)Drug

    Rogaratinib administered as oral (p.o.) tablets twice daily (b.i.d.) continuously

  • ChemotherapyDrug

    Chemotherapy as taxane (docetaxel or paclitaxel) or vinflunine administered through intravenous (i.v.) infusion every 3 weeks (on day 1 of a 21-day cycle) The choice of the chemotherapy is at the discretion of the investigator, taking into consideration the status of the authorization or treatment guidelines in the given country.

Study groups in NCT03410693
Study groupRoleWhat they receive
RogaratinibExperimentalRogaratinib treatment study arm, comprising 1. Pre-treatment period, including FGFR testing and screening, 2. Treatment period, and 3. Follow-up period, including active follow-up and long-term follow-up. Patients will be considered "on study" during the pre-treatment, treatment and active followup periods. During the long-term follow-up period the patients will be considered "off study".
Receives: Drug: Rogaratinib (BAY1163877)
ChemotherapyActive comparatorChemotherapy treatment study arm, comprising 1. Pre-treatment period, including FGFR testing and screening, 2. Treatment period, and 3. Follow-up period, including active follow-up and long-term follow-up. Patients will be considered "on study" during the pre-treatment, treatment and active followup periods. During the long-term follow-up period the patients will be considered "off study".
Receives: Drug: Chemotherapy

What is being measured

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

  1. Objective Response Rate (ORR) - Central Assessment

    ORR is defined as the percentage of participants with complete response (CR) or partial response (PR). participants for whom overall best response is not CR or PR, as well as participants without any post-baseline tumor assessment will be considered non-responders.

    Measured: From start of treatment up to end of active follow-up, approximately 29 months

Secondary outcomes (4)

  1. Disease-control Rate (DCR) - Central Assessment

    DCR was defined as the percentage of participants whose overall best response was not a progressive disease (i.e., CR, PR, stable disease [SD] or Non CR/Non PD).

    Measured: From start of treatment till end of active follow-up, approximately 29 months

  2. Progression-free Survival (PFS) - Central Assessment

    Progression free survival (PFS) was defined as the time (days) from randomization to date of first observed disease progression (radiological or clinical assessment or both) or death due to any cause (if death occurred before progression was documented).

    Measured: From start of treatment till end of active follow-up, approximately 29 months

  3. Duration of Response (DOR) - Central Assessment

    DOR (for patients with PR and CR only) was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression (including symptomatic deterioration) or death, whichever was earlier

    Measured: From start of treatment till end of active follow-up, approximately 29 months

  4. Number of Participants With Treatment Emergent Adverse Events

    A treatment-emergent event was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment

    Measured: From start of treatment up to 30 days after the last administration of study treatment, approximately 29 months

Timeline

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

  1. First posted25 Jan 2018
  2. Study start31 May 2018
  3. Primary completion27 Oct 2020
  4. Study completion27 Oct 2020

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03410693
Sponsor's protocol ID
17403
Other IDs
2016-004340-11, 2016
Acronym
FORT-1
Status last verified
Sep 2022
First submitted
19 Jan 2018
Last updated
28 Sep 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Sternberg CN, Petrylak DP, Bellmunt J, Nishiyama H, Necchi A, Gurney H, Lee JL, van der Heijden MS, Rosenbaum E, Penel N, Pang ST, Li JR, Garcia Del Muro X, Joly F, Papai Z, Bao W, Ellinghaus P, Lu C, Sierecki M, Coppieters S, Nakajima K, Ishida TC, Quinn DI. FORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression. J Clin Oncol. 2023 Jan 20;41(3):629-639. doi: 10.1200/JCO.21.02303. Epub 2022 Oct 14.

    PubMed 36240478

  • Grunewald S, Politz O, Bender S, Heroult M, Lustig K, Thuss U, Kneip C, Kopitz C, Zopf D, Collin MP, Boemer U, Ince S, Ellinghaus P, Mumberg D, Hess-Stumpp H, Ziegelbauer K. Rogaratinib: A potent and selective pan-FGFR inhibitor with broad antitumor activity in FGFR-overexpressing preclinical cancer models. Int J Cancer. 2019 Sep 1;145(5):1346-1357. doi: 10.1002/ijc.32224. Epub 2019 Mar 13.

    PubMed 30807645

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Rogaratinib (BAY1163877) and Chemotherapy in people with Carcinoma, Transitional Cell, run by Bayer at 161 sites in 29 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 8 inclusion and 18 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: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 161 sites in Japan, United States, Spain, France, Italy and 24 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 29 Dec 2021). 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?

Objective Response Rate (ORR) - Central Assessment (time frame: From start of treatment up to end of active follow-up, approximately 29 months). 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 NCT03410693, 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 28 Sep 2022.

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