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Targeted pill shows promise for rare genetic tumor types

NCT ID NCT04083976

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This phase 2 study tested the drug erdafitinib in 316 adults and children with advanced solid tumors that have specific FGFR gene mutations or fusions. The main goal was to see if the drug could shrink tumors. Participants took erdafitinib tablets daily. The study is now complete, and results will help determine if this targeted therapy is effective for these rare tumor types.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Erdafitinib (oral tablet)
What this could lead to
If successful, erdafitinib could offer a new treatment option for people with advanced solid tumors that have specific FGFR gene changes.
What could go wrong
This is a phase 2 trial, so results are still early. The drug may not work for all tumor types, and side effects are possible. It is not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

316 people

The number who actually took part.

Started

Nov 2019

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologic demonstration of an unresectable, locally advanced, or metastatic solid tumor malignancy with an fibroblast growth factor receptor (FGFR) mutation or FGFR gene fusion * Measurable disease * Participant must have received at least one prior line of systemic therapy in the advanced, unresectable, or metastatic setting; or is a child or adolescent participant with a newly-diagnosed solid tumor and no acceptable standard therapies * Documented progression of disease, defined as any progression that requires a change in treatment, prior to full study screening Exclusion Criteria: * Has had prior chemotherapy, targeted therapy, or treatment with an investigational anticancer agent within 15 days or less than or equal to (\<=) 5 half-lives of the agent (whichever is longer) and up to a maximum of 30 days before the first dose of erdafitinib * The presence of FGFR gatekeeper and resistance mutations * Histologic demonstration of urothelial carcinoma * Hematologic malignancy (i.e., myeloid and lymphoid neoplasms * For non-small cell lung cancer participants only: pathogenic somatic mutations or gene fusions in the following genes: EGFR, ALK, ROS1, NTRK, BRAF V600E and KRAS * Active malignancies other than for disease requiring therapy

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor

Contacts and locations

Locations

  • ARS Médica

    San Salvador de Jujuy, Y4600AFW, Argentina

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • ASST di Monza

    Monza, 20900, Italy

  • AZ Klina

    Brasschaat, 2930, Belgium

  • AZ Maria Middelares

    Ghent, 9000, Belgium

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85711, United States

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asan Medical Center 1

    Seoul, 05505, South Korea

  • Asan Medical Center 2

    Seoul, 05505, South Korea

  • Asklepios Klinik Altona

    Hamburg, 22763, Germany

  • Associacao Hospital de Caridade Ijui

    Ijuí, 98700-000, Brazil

  • Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge

    Goiânia, 74605-070, Brazil

  • Aurora Research Institute

    Wauwatosa, Wisconsin, 53226, United States

  • Azienda Ospedaliera S. Maria Terni

    Terni, 5100, Italy

  • Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli

    Naples, 80138, Italy

  • Beijing Luhe Hospital, Capital Medical University

    Beijing, 101100, China

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, 100070, China

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED, United Kingdom

  • Bristol Royal Hospital for Children

    Bristol, BS2 8AE, United Kingdom

  • CEMIC Saavedra

    Buenos Aires, C1431FWN, Argentina

  • CHU De Poitiers

    Poitiers, 86021, France

  • CHU UCL Namur - Site Dinant

    Dinant, 5500, Belgium

  • CHU UCL Namur - Site Godinne

    Yvoir, 5530, Belgium

  • CHU UCL Namur - Site Sainte Elisabeth

    Namur, 5000, Belgium

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, 100021, China

  • Cancer Hospital, FuDan University

    Shanghai, 200032, China

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256, United States

  • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

    Córdoba, 5000, Argentina

  • Centralny Szpital Kliniczny MSWiA w Warszawie

    Warsaw, 02-507, Poland

  • Centre Francois Baclesse

    Caen, 14000, France

  • Centre Georges Francois Leclerc

    Dijon, 21000, France

  • Centre Jean Perrin

    Clermont-Ferrand, 63011, France

  • Centre Leon Berard

    Lyon, 69008, France

  • Centre Oscar Lambret

    Lille, 59000, France

  • Centro Oncológico Korben

    Buenos Aires, C1426AGE, Argentina

  • Centrum Medyczne Pratia Poznan

    Skorzewo, 60 185, Poland

  • Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy

    Bydgoszcz, 85 796, Poland

  • Chang Gung Medical Foundation

    Kaohsiung City, 833, Taiwan

  • Chang Gung Memorial Hospital Linkou Branch

    Taoyuan City, 333, Taiwan

  • Changhua Christian Hospital

    Changhua, 50006, Taiwan

  • Charité

    Berlin, 10115, Germany

  • Chi Mei Medical Center Liu Ying

    Tainan, 736, Taiwan

  • Chi Mei Medical Center Yong Kang

    Tainan, 710, Taiwan

  • China Medical University Hospital

    Taichung, 403, Taiwan

  • Chinese PLA General Hospital

    Beijing, 100853, China

  • Chongqing Southwest Hospital

    Chongqing, 400038, China

  • Chris O'Brien Lifehouse

    Camperdown, 2050, Australia

  • Clinica Univ. de Navarra

    Madrid, 28027, Spain

  • Cliniques St Pierre

    Ottignies, 1340, Belgium

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Derriford Hospital

    Plymouth, PL6 8DH, United Kingdom

  • E-Da Cancer Hospital

    Kaohsiung City, 82445, Taiwan

  • Eastern Theater General Hospital, Qinhuai District Medical Area

    Nanjing, 210002, China

  • Emory University

    Atlanta, Georgia, 30022, United States

  • Fiona Stanley Hospital

    Murdoch, 6150, Australia

  • First affiliated Hospital of Zhejiang University

    Hangzhou, 310003, China

  • Flinders Centre for Innovation in Cancer

    Adelaide, 5042, Australia

  • Fondazione G Pascale Istituto Nazionale Tumori IRCCS

    Naples, 80138, Italy

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Fujita Health University Hospital

    Toyoake, 470-1192, Japan

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900, Brazil

  • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

    São Paulo, 01246 000, Brazil

  • Fundacao Pio XII

    Barretos, 14784-400, Brazil

  • GRAACC

    São Paulo, 4039001, Brazil

  • Grand Hopital de Charleroi, site Notre Dame

    Charleroi, 6000, Belgium

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hawaii Cancer Care

    ‘Aiea, Hawaii, 96701, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hiroshima University Hospital

    Hiroshima, 734 8551, Japan

  • Hopital Saint André

    Bordeaux, 33075, France

  • Hopital de la Timone

    Marseille, 130005, France

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 08035, Spain

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010, Spain

  • Hosp. Infantil Univ. Nino Jesus

    Madrid, 28009, Spain

  • Hosp. Sant Joan de Deu

    Barcelona, 08950, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. La Paz

    Madrid, 28046, Spain

  • Hosp. Univ. Quiron Dexeus

    Barcelona, 08028, Spain

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034, Spain

  • Hosp. Virgen Del Rocio

    Seville, 41013, Spain

  • Hospital Aleman

    Buenos Aires, C1118AAT, Argentina

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    São Paulo, 05410-030, Brazil

  • Hospital Italiano de La Plata

    La Plata Lpl Lpl, 1900, Argentina

  • Hospital Privado de Comunidad

    Mar del Plata, B7602CBM, Argentina

  • Hospital Sao Rafael

    Salvador, 41253 190, Brazil

  • Hospital Universitario Austral

    Pilar, 1629, Argentina

  • Huashan Hospital Fudan University

    Shanghai, 200040, China

  • Inst. Cat. Doncologia-H Duran I Reynals

    L'Hospitalet de Llobregat, 08908, Spain

  • Institut Curie

    Paris, 75005, France

  • Institut Gustave Roussy

    Villejuif, 94800, France

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 54519, France

  • Instituto D Or de Pesquisa e Ensino IDOR

    Rio de Janeiro, 22281 100, Brazil

  • Instituto Fleni

    Buenos Aires, C1428AQK, Argentina

  • Instituto de Investigaciones Clinicas Mar del Plata

    Mar del Plata, B7600FZN, Argentina

  • Instituto de Investigaciones Metabólicas

    Buenos Aires, C1012AAR, Argentina

  • Instituto de Medicina Integral Professor Fernando Figueira

    Recife, 50070-550, Brazil

  • Instytut Matki i Dziecka

    Warsaw, 01 211, Poland

  • Intergrated Clinical Oncology Network Pty Ltd (ICON)

    South Brisbane, 4101, Australia

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050-170, Brazil

  • Istituto Ortopedico Rizzoli

    Bologna, 40136, Italy

  • Jilin cancer hospital

    Changchun, 130012, China

  • Jolimont

    Haine-Saint-Paul, 7100, Belgium

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Klinikum rechts der Isar der TU Munchen

    München, 81675, Germany

  • Levine Cancer Institute, Carolinas HealthCare System

    Charlotte, North Carolina, 28204, United States

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59075-740, Brazil

  • Liga Paranaense de Combate ao Cancer

    Curitiba, 81520 060, Brazil

  • MD Anderson

    Houston, Texas, 77030, United States

  • Maine Medical Center

    Scarborough, Maine, 04074, United States

  • Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

    Dresden, 01307, Germany

  • Memorial Cancer Institute

    Hollywood, Florida, 33021, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10128, United States

  • Mount Sinai

    New York, New York, 10029, United States

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781, Poland

  • National Cancer Center Hospital

    Chūōku, 104 0045, Japan

  • National Cancer Center Hospital East

    Kashiwa, 277 8577, Japan

  • National Cheng Kung University Hospital

    Tainan, 710, Taiwan

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, 791-0280, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • NorthWest Medical Specialties, PLLC

    Tacoma, Washington, 98405, United States

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22250 905, Brazil

  • Oncology Consultants Texas

    Houston, Texas, 77030, United States

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242, United States

  • Ospedale Borgo Roma

    Verona, 37134, Italy

  • Ospedale S. Maria Della Misericordia

    Perugia, 06132, Italy

  • Ospedale Santa Chiara AO Universitaria Pisana

    Pisa, 56126, Italy

  • Peking University Third Hospital

    Beijing, 100191, China

  • Przychodnia Lekarska KOMED Roman Karaszewski

    Konin, 62-500, Poland

  • Real e Benemerita Associacao Portuguesa de Beneficencia

    São Paulo, 01321-001, Brazil

  • Rocky Mountain Cancer Centers

    Colorado Springs, Colorado, 80907, United States

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai, 200025, China

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

    Krakow, 31 501, Poland

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Samsung Medical Center 1

    Seoul, 06351, South Korea

  • Samsung Medical Center 2

    Seoul, 06351, South Korea

  • Sanatorio Britanico de Rosario

    Rosario, 2000, Argentina

  • Seoul National University Hospital

    Seoul, 3080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Severance Hospital Yonsei University Health System 1

    Seoul, 03722, South Korea

  • Severance Hospital Yonsei University Health System 2

    Seoul, 03722, South Korea

  • Shanghai Zhongshan Hospital

    Shanghai, 200032, China

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, 01308 901, Brazil

  • St Vincent s Hospital Sydney

    Darlinghurst, 2010, Australia

  • St Vincents Hospital Melbourne

    Fitzroy, 3065, Australia

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, 510289, China

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Tennessee Oncology, PLLC

    Chattanooga, Tennessee, 37404, United States

  • Texas Oncology Baylor Charles A Sammons Cancer Center

    Dallas, Texas, 75246, United States

  • Texas Oncology Odessa-West Texas Cancer Center

    Odessa, Texas, 79761, United States

  • Texas Oncology San Antonio Northeast

    San Antonio, Texas, 78217, United States

  • Texas Oncology-Fort Worth Cancer Center

    Fort Worth, Texas, 76104, United States

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591, South Korea

  • The Catholic University of Korea Seoul St Marys Hospital 1

    Seoul, 06591, South Korea

  • The Christie Nhs Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • The Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • The Royal Marsden NHS Trust

    Sutton, SM2 5PT, United Kingdom

  • Third Military Medical University Daping Hospital Cancer Center

    Chongqing, 400042, China

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UCL Hopital Saint-Luc

    Brussels, 1200, Belgium

  • UZ Gent

    Ghent, 9000, Belgium

  • UZA

    Edegem, 2650, Belgium

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • Universitaetsklinikum Frankfurt

    Frankfurt, 60385, Germany

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Heidelberg 1

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Koeln

    Cologne, 50937, Germany

  • Universitaetsklinikum Leipzig

    Leipzig, 04103, Germany

  • Universitatsklinikum Tubingen

    Tübingen, 72076, Germany

  • Universitatsmedizin der Johannes Gutenberg Universitat Mainz

    Mainz, 55131, Germany

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • West China Hospital,Sichuan University

    Chengdu, 610041, China

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

    Lodz, 93 513, Poland

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

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Other studies related to the condition(s) this trial covers.