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Cancer drug trial halted early – what happened?

NCT ID NCT04189445

Disease control Sponsor: Taiho Oncology, Inc. 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested the drug futibatinib in 115 people with advanced solid tumors or blood cancers that have specific FGFR gene changes. The goal was to see if the drug could shrink tumors or cause remission. The study was terminated early, so final results are not yet clear.

What this could mean

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

Active substance
Futibatinib (a targeted cancer drug taken as a daily pill)
What this could lead to
If successful, futibatinib could offer a new treatment option for certain cancers driven by FGFR gene changes.
What could go wrong
This trial was terminated early, so data is limited. The drug may not work for all FGFR-related cancers, and side effects are possible.

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

115 people

The number who actually took part.

Started

Aug 2020

Finished

Nov 2024

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

18 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: 1. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 2. Known FGFR aberration status and tumor type that meet all of the criteria for 1 of the following cohorts: a. Cohort A i. Histologically-confirmed, locally-advanced, advanced, or metastatic solid tumors harboring a FGFR1-4 ii. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 iii. Had disease progression/recurrence after standard treatment for their cancer b. Cohort B i. Histologically-confirmed, locally-advanced, advanced, or metastatic gastric or gastroesophageal junction cancer harboring a FGFR2 amplification. ii. Measurable disease per RECIST 1.1 iii. Received at least 2 prior systemic regimens for advanced/metastatic disease iv. Experienced disease progression/recurrence during or after the most recent prior systemic treatment for advanced/metastatic gastric cancer or GEJ cancer c. Cohort C i. Confirmed myeloid or lymphoid neoplasms as defined by WHO criteria with a FGFR1 rearrangement ii. Not a candidate for hematological stem cell transplant (HSCT) or relapsed after HSCT and donor lymphocyte infusion, and progressed and not a candidate for other therapies Exclusion Criteria: 1. History and/or current evidence of any of the following disorders: 1. Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator 2. Ectopic mineralization/calcification including, but not limited to, soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant in the opinion of the Investigator 3. Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant in the opinion of the Investigator. 2. Prior treatment with an FGFR inhibitor 3. Brain metastases that are untreated or clinically or radiologically unstable (that is, have been stable for \<1 month)

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Conditions

The condition(s) this trial relates to.

gastric cancer gastric carcinoma gastric neoplasm gastroesophageal adenocarcinoma gastroesophageal cancer gastroesophageal junction adenocarcinoma hematopoietic and lymphoid cell neoplasm lymphoid neoplasm metastatic malignant neoplasm myeloid neoplasm myeloid neoplasm associated with FGFR1 rearrangement neoplasm Neoplasm Metastasis

As listed by the trial registrant

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

Advanced or metastatic gastric or gastroesophageal cancer Advanced or metastatic solid tumor Myeloid or lymphoid neoplasms (MLN)

Contacts and locations

Locations

  • Acibadem Adana Hospital

    Adana, 01130, Turkey (Türkiye)

  • Acibadem Maslak Hospital

    Istanbul, 34457, Turkey (Türkiye)

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681, Japan

  • Akademiska Sjukhuset

    Uppsala, 75185, Sweden

  • Antoni van Leeuwenhoek

    Amsterdam, 1066 CX, Netherlands

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134, Italy

  • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Trento)

    Verona, 37124, Italy

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234-2165, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215-5400, United States

  • Centre Antoine Lacassagne

    Nice, Alpes Maritimes, 06200, France

  • Centre Georges François Leclerc

    Dijon, Côte-d'Or, 21079, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Rhone, 69495, France

  • Centre Léon Bérard

    Lyon, Rhone, 69008, France

  • Centre Paul Strauss

    Strasbourg, Bas Rhin, 67000, France

  • Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos

    Lisbon, 1169-050, Portugal

  • Centro Hospitalar do Porto, E.P.E - Hospital de Santo Antonio

    Porto, 4099-001, Portugal

  • Clinica Universidad de Navarra

    Pamplona, 31008, Spain

  • Erasmus Medisch Centrum

    Rotterdam, 3015 AA, Netherlands

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 53705, United States

  • Fundação Champalimaud

    Lisbon, 4099-001, Portugal

  • Georgetown University - Lombardi Comprehensive Cancer Center

    Washington D.C., District of Columbia, 20007, United States

  • Henry Ford Hospital

    Woodhaven, Michigan, 48183, United States

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

  • Hong Kong United Oncology Centre

    Jordon, 0000, Hong Kong

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario HM Madrid Sanchinarro

    Madrid, 28050, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Houston Methodist Cancer Center

    Houston, Texas, 77030, United States

  • Hôpital Saint-Louis

    Paris, Paris, 75475, France

  • IEO Istituto Europeo di Oncologia

    Milan, 20141, Italy

  • Institut Bergonié

    Bordeaux, Gironde, 33076, France

  • Institut Gustave Roussy

    Villejuif, Val De Marne, 94805, France

  • Institut Jules Bordet

    Brussels, 1000, Belgium

  • Instituto Valenciano de Oncologia IVO

    Valencia, 46009, Spain

  • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

    Meldola, Forli - Cesena, 47014, Italy

  • Karolinska universitetssjukhuset - Solna

    Solna, 171 64, Sweden

  • Mercy Clinic Oncology and Hematology - Coletta

    Oklahoma City, Oklahoma, 73120, United States

  • NHO Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280, Japan

  • Namik Kemal University

    Tekirdağ, 59100, Turkey (Türkiye)

  • National Cancer Center Hospital

    Chūōku, Tokyo-To, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National University Cancer Institute

    Singapore, 119074, Singapore

  • Osaka University Hospital

    Suita-shi, Osaka, 565-0871, Japan

  • Ospedale Sacro Cuore Don Calabria

    Negrar, Verona, 37024, Italy

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute UK

    London, Greater London, W1G 6AD, United Kingdom

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • The University of Hong Kong

    Hong Kong, Hong Kong

  • The University of Texas M. D. Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UCLA Medical Center

    Los Angeles, California, 90404, United States

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Universitaetsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Universitaetsklinikum Koeln

    Cologne, North Rhine-Westphalia, 50924, Germany

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

More trials for these conditions

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