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Targeted drug pemigatinib tested in tumors with FGFR mutations – trial stopped early

NCT ID NCT03822117

Disease control Sponsor: Incyte Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested the drug pemigatinib in 111 people with advanced solid tumors that have specific FGFR gene mutations or translocations. The goal was to see if the drug could shrink tumors. The trial was terminated early, so the full results are not available.

What this could mean

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

Active substance
pemigatinib
What this could lead to
If successful, pemigatinib could offer a new treatment option for people with certain advanced solid tumors that have specific genetic changes (FGFR mutations or translocations).
What could go wrong
This trial was terminated early, so results are limited. The drug may not work for all tumor types, and side effects are possible. More research is needed.

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

111 people

The number who actually took part.

Started

Oct 2019

Finished

Mar 2022

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: * Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic or is surgically unresectable. * Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors). Tumor lesions located in a previously irradiated area or in an area subjected to other loco-regional therapy are considered measureable if progression has been clearly demonstrated in the lesion. * Documentation of an FGFR1-3 gene mutation or translocation. * Objective progression after at least 1 prior therapy and no therapy available that is likely to provide clinical benefit. Participants who are intolerant to or decline the approved therapy are eligible only if they have no therapy available that is likely to provide clinical benefit. * Eastern Cooperative Oncology Group performance status 0 to 2. * Baseline archival tumor specimen (if less than 24 months from date of screening) or willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Must be a tumor block or approximately 15 unstained slides from biopsy or resection of primary tumor or metastasis. * Willingness to avoid pregnancy or fathering children. Exclusion Criteria: * Prior receipt of a selective FGFR inhibitor in the past 6 months. * Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of pemigatinib. * Cannot be a candidate for potentially curative surgery. * Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination. * Radiation therapy administered within 2 weeks of enrollment/first dose of study treatment. * Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases). * Known additional malignancy that is progressing or requires active treatment. * History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues. * Clinically significant or uncontrolled cardiac disease. * Active chronic or current infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment within 2 weeks before enrollment (participants with asymptomatic chronic infections on prophylactic treatment are allowed). * Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (defined as elevated transaminases or cirrhosis; chronic HBV/HCV infection with no cirrhosis and no elevated transaminases is allowed). * Known HIV infection. * Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or five half-lives (whichever is longer) before the first dose of study drug/treatment. * Women who are pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

Apert syndrome cancer neoplasm

As listed by the trial registrant

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

Solid tumor malignancy

Contacts and locations

Locations

  • A.P.H. Paris Hopital Cochin

    Paris, 75014, France

  • Assaf Harofeh Medical Center

    Ẕerifin, 7030000, Israel

  • CENTRE GEORGES FRAN�OIS LECLERC

    Dijon, 21079, France

  • Cancer Institute of Greenville Health System

    Greenville, South Carolina, 29605, United States

  • Cancer Treatment Centers of America

    Goodyear, Arizona, 85338, United States

  • Cancer Treatment Centers of America

    Zion, Illinois, 60099, United States

  • Carle Cancer Center

    Urbana, Illinois, 61801, United States

  • Central Maine Medical Center

    Lewiston, Maine, 04240, United States

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centro Integral Oncologico Clara Campal (Ciocc)

    Madrid, 28050, Spain

  • Centro Ricerche Cliniche Di Verona (Crc)

    Verona, 37134, Italy

  • Chao Family Comprehensive Cancer Center University of California, Irvine

    Orange, California, 92868, United States

  • Clinica Universidad de Navarra (Cun)

    Pamplona, 31008, Spain

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Duke Cancer Center

    Durham, North Carolina, 27710, United States

  • Edward H Kaplan & Associates

    Skokie, Illinois, 60076, United States

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705, United States

  • Florida Cancer Specialists

    Tallahassee, Florida, 32308, United States

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401, United States

  • Florida Cancer Specialists & Research Institute

    Fort Myers, Florida, 33901, United States

  • Fondazione Del Piemonte Per L Oncologia Ircc Candiolo

    Candiolo, 10060, Italy

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milan, 20133, Italy

  • Ha Emek Medical Center

    Afula, 18101, Israel

  • Hadassah Hebrew University Medical Center Ein Karem Hadassah

    Jerusalem, 90000, Israel

  • Hospital Clinic I Provincial

    Barcelona, 08036, Spain

  • Hospital General Universitario Vall D Hebron

    Barcelona, 08035, Spain

  • Hospital Regional Universitario de Malaga

    Málaga, 29010, Spain

  • Hospital Saint Louis

    Paris, 75010, France

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Y Politcnico de La Fe

    Valencia, 46026, Spain

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005, United States

  • Imperial College Healthcare Nhs Trust - Hammersmith Hospital

    London, W12 0HS, United Kingdom

  • Indiana University Health - Arnett Cancer Care

    Lafayette, Indiana, 47904, United States

  • Inselspital - Universitaetsspital Bern

    Bern, 03010, Switzerland

  • Institut Bergonie

    Bordeaux, 33000, France

  • Institut Universitaire Du Cancer de Toulouse Oncopole

    Toulouse, 31059, France

  • Istituto Nazionale Tumori Irccs Fondazione Pascale

    Naples, 80131, Italy

  • Istituto Nazionale Tumori Regina Elena Irccs

    Roma, 00144, Italy

  • Joe Arrington Cancer Center

    Lubbock, Texas, 79410, United States

  • John Wayne Cancer Institute

    Santa Monica, California, 90404, United States

  • Kanagawa Cancer Center

    Yokohama, 241-8515, Japan

  • Kanazawa University Hospital

    Ishikawa, 920-8641, Japan

  • Keio University Hospital

    Shinjuku-ku, 160-8582, Japan

  • Kobe University Hospital

    Kobe, 650-0017, Japan

  • L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI

    Bologna, 40138, Italy

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Multicare Institute For Research & Innovation

    Tacoma, Washington, 98405, United States

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395, Japan

  • Ochsner Clinic

    New Orleans, Louisiana, 70121, United States

  • Oncology Specialists of Charlotte

    Charlotte, North Carolina, 28204, United States

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva, 4841492, Israel

  • Rambam Health Care Campus

    Haifa, 3525408, Israel

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute

    London, W1G 6AD, United Kingdom

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Shizuoka Cancer Center

    Shizuoka, 411-8777, Japan

  • Southwestern Regional Medical Center

    Tulsa, Oklahoma, 74133, United States

  • St. Joseph Heritage Healthcare

    Santa Rosa, California, 95403, United States

  • Stanford Cancer Center

    Palo Alto, California, 94304, United States

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • Summit Medical Group

    Florham Park, New Jersey, 07932, United States

  • The Finsen Centre National Hospital

    Copenhagen, 02100, Denmark

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85724, United States

  • The West Clinic Pc

    Germantown, Tennessee, 38138, United States

  • Tohoku University Hospital

    Sendai, 980-8574, Japan

  • Umass Memorial Medical Center, Inc.

    Worcester, Massachusetts, 01655, United States

  • Universitaetsklinikum in Tubingen

    Tübingen, 72076, Germany

  • Universitatsklinikum Koln

    Cologne, 50937, Germany

  • Universitatsspital Zurich

    Zurich, 08091, Switzerland

  • University College London Hospitals (Uclh)

    London, NW1 2PG, United Kingdom

  • University Hospital Grosshadern Munich

    Munich, 81377, Germany

  • University Medical Center Freiburg

    Freiburg im Breisgau, 79106, Germany

  • University Medical Centre Hamburg-Eppendorf, Centre of Oncology

    Hamburg, 20246, Germany

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792, United States

  • Virginia Cancer Specialists, Pc

    Fairfax, Virginia, 22031, United States

  • Virginia Oncology Associates-Lake Wright

    Norfolk, Virginia, 23502, United States

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • West Virginia University Hospitals Inc

    Morgantown, West Virginia, 26506, United States

  • Winthrop University Hospital

    Mineola, New York, 11501, United States

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