A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma

Smart Patients is an online community for patients and their families. Join us to talk with other patients about the latest research for your condition.

Overview

Status	Recruiting
Phase	Phase 3
Sponsor	Incyte Corporation
Start date	June 2019
End date	October 2027
Enrollment	434 participants
Identifiers	NCT03656536, INCB 54828-302

Conditions

Unresectable Cholangiocarcinoma, Metastatic Cholangiocarcinoma

Treatments

Pemigatinib, Gemcitabine, Cisplatin

Summary

The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.

Recruiting in the following locations

US States	Arizona, California, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, West Virginia, Wisconsin
Other countries	Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom

Mayo Clinic Arizona
Phoenix, Arizona	Recruiting
Marin Cancer Care
Greenbrae, California	Completed
Georgetown University-Lombardi Comprehensive Cancer Center
Washington, District of Columbia	Completed
Mayo Clinic-Florida
Jacksonville, Florida	Recruiting
Mount Sinai Medical Center Comprehensive Cancer Center
Miami Beach, Florida	Recruiting
Winship Cancer Institute of Emory University
Atlanta, Georgia	Completed
University of Chicago Medical Center
Chicago, Illinois	Completed
Parkview Research Center
Fort Wayne, Indiana	Completed
University of Iowa Hospital and Clinics
Iowa City, Iowa	Completed
The University of Kansas Cancer Center
Westwood, Kansas	Completed
Ochsner Clinic Foundation Ocf Ochsner Cancer Institute Oci
New Orleans, Louisiana	Completed
Johns Hopkins Oncology Center
Baltimore, Maryland	Completed
Beth Israel Deaconess Medical Center
Boston, Massachusetts	Recruiting
Boston Medical Center
Boston, Massachusetts	Completed
Barbara Ann Karmanos Cancer Hospital
Detroit, Michigan	Recruiting
Henry Ford Hospital
Detroit, Michigan	Completed
Karmanos Cancer Institute
Farmington Hills, Michigan	Recruiting
Mayo Clinic
Rochester, Minnesota	Recruiting
Comprehensive Cancer Centers of Nevada-Twain
Las Vegas, Nevada	Completed
Summit Medical Group
Florham Park, New Jersey	Recruiting
Icahn School of Medicine At Mount Sinai
New York, New York	Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York	Withdrawn
White Plains Hospital
White Plains, New York	Completed
Cleveland Clinic Foundation
Cleveland, Ohio	Completed
University Hospitals Cleveland Medical Center
Cleveland, Ohio	Completed
Oregon Health & Science University
Portland, Oregon	Completed
Providence Portland Med. Ctr
Portland, Oregon	Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania	Recruiting
Greenville Hospital System University Medical Center Institute For Translational Oncology Research
Greenville, South Carolina	Completed
Baylor Scott and White Research Institute
Dallas, Texas	Recruiting
Houston Methodist Research Institute
Houston, Texas	Recruiting
Riverside Regional Medical Center
Newport News, Virginia	Completed
Virginia Commonwealth University
Richmond, Virginia	Not yet recruiting
Virginia Mason Medical Center
Seattle, Washington	Recruiting
West Virginia University Cancer Institute
Morgantown, West Virginia	Completed
Aurora Research Institute
Wauwatosa, Wisconsin	Recruiting
Landeskrankenhaus Universitatsklinikum Graz
Graz, Austria	Completed
Innsbruck University Hospital
Innsbruck, Austria	Recruiting
Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz
Linz, Austria	Completed
Salzburger Universitatsklinikum
Salzburg, Austria	Recruiting
Landeskrankenhaus Steyr
Steyr, Austria	Completed
Allgemeines Krankenhaus Der Stadt Wien
Vienna, Austria	Recruiting
Ulb Hospital Erasme
Bruxelles, Belgium	Recruiting
Universitair Ziekenhuis Brussel
Bruxelles, Belgium	Completed
Universitair Ziekenhuis Gent
Gent, Belgium	Recruiting
Hospital de Jolimont
Haine-st-paul, Belgium	Completed
Az Groeninge Campus Kennedylaan
Kortrijk, Belgium	Completed
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven, Belgium	Recruiting
Chu Ucl Namur University Hospital Mont-Godinne
Yvoir, Belgium	Completed
Tom Baker Cancer Centre
Calgary, Canada	Recruiting
Cancercare Manitoba
Winnipeg, Canada	Not yet recruiting
Nova Scotia Health Authority/Qeii Health Sciences Centre
Halifax, Canada	Recruiting
Princess Margaret Cancer Center
Toronto, Canada	Recruiting
McGill University Health Centre Research Institute
Montreal, Canada	Recruiting
Peking Union Medical College Hospital
Beijing, China	Recruiting
West China Hospital Sichuan University
Chengdu, China	Recruiting
Fujian Cancer Hospital
Fuzhou, China	Recruiting
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
Guangdong, China	Recruiting
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
Guangzhou, China	Recruiting
Shulan Hangzhou Hospital Co Ltd
Hangzhou, China	Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China	Recruiting
Heilongjiang Province Cancer Hospital
Harbin, China	Recruiting
University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)
Hefei, China	Recruiting
Kunming 1St People'S Hospital
Kunming, China	Recruiting
Jiangsu Province Hospital
Nanjing, China	Recruiting
Xinhua Hospital
SHanghai, China	Recruiting
The Affiliated Hospital of Qingdao University
Shandong, China	Recruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China	Recruiting
Zhongshan Hospital Fudan University
Shanghai, China	Recruiting
Sichuan Cancer Hospital
Sichuan, China	Recruiting
Tianjin Medical University Cancer Institute Hospital
Tianjin, China	Recruiting
Hubei Cancer Hospital
Wuhan, China	Recruiting
Tongji Hospital Huazhong University of Science and Technology
Wuhan, China	Recruiting
Northern Jiangsu Peoples Hospital
Yangzhou, China	Recruiting
Herlev Og Gentofte Hospital
Herlev, Denmark	Completed
Docrates Cancer Center
Helsinki, Finland	Completed
Helsinki University Central Hospital
Helsinki, Finland	Completed
Tampere University Hospital
Tampere, Finland	Completed
Institut Sainte Catherine
Avignon Cedex 9, France	Recruiting
Chu Besancon Hospital Jean Minjoz
Besançon, France	Recruiting
Institut Bergonie
Bordeaux Cedex, France	Completed
Hopital Beaujon
Clichy, France	Recruiting
Chu de Limoges - Hospital Dupuytren
Limoges Cedex, France	Recruiting
Hopital Prive Jean Mermoz
Lyon Cedex 08, France	Completed
Chu Hopital de La Timone
Marseille Cedex 5, France	Recruiting
Centre Hospitalier Universitaire de Nantes
Nantes, France	Not yet recruiting
Centre Antoine Laccassagne
Nice Cedex 02, France	Completed
Hospital Universitaire Pitie-Salpetriere
Paris Cedex 13, France	Recruiting
Hopital Europeen Georges Pompidou (Hegp)
Paris Cedex 15, France	Recruiting
Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque
Pessac Cedex, France	Recruiting
Hospital de La Miletrie
Poitiers Cedex, France	Recruiting
Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
Rouen Cedex, France	Recruiting
University Hospital of Saint Etienne
Saint Etienne, France	Recruiting
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
Saint Herblain, France	Recruiting
Chu Toulouse Hopital Rangueil
Toulouse Cedex 9, France	Completed
Chu Vandoeuvre-Les-Nancy Hopital Brabois
Vandoeuvre Les Nancy, France	Recruiting
Institut Gustave Roussy
Villejuif Cedex, France	Recruiting
University Medical Center Rwth Aachen
Aachen, Germany	Recruiting
Charite - Campus Virchow-Klinikum
Berlin, Germany	Recruiting
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, Germany	Recruiting
Universitatsklinikum Bonn Aoer
Bonn, Germany	Recruiting
Klinikum Bremen-Nord
Bremen, Germany	Completed
University Clinic Carl Gustav Carus Technical University Dresden
Dresden, Germany	Recruiting
Klinikum Der Johann Wolfgang Goethe University
Frankfurt Am Main, Germany	Recruiting
University Medical Center Freiburg
Freiburg, Germany	Completed
Asklepios Klinik Altona
Hamburg, Germany	Recruiting
Universitatsklinikum Hamburg Eppendorf
Hamburg, Germany	Recruiting
Hannover Medical School
Hannover, Germany	Recruiting
Universitaetsklinikum Des Saarlandes
Homburg / Saar, Germany	Completed
Universitatsklinikum Koln
Koln, Germany	Recruiting
Universitatsklinikum Leipzig Aor
Leipzig, Germany	Completed
Klinikum Ludwigsburg
Ludwigsburg, Germany	Completed
Otto-Von-Guericke-Universitat Magdeburg
Magdeburg, Germany	Recruiting
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, Germany	Completed
University Hospital Grosshadern Munich
Munich, Germany	Recruiting
Klinikum Nuernberg
Nuernberg, Germany	Recruiting
Universitaetsklinikum in Tubingen
Tubingen, Germany	Recruiting
University Hospital Tuebingen
Tubingen, Germany	Recruiting
Universitatkinikums Ulm
ULM, Germany	Recruiting
St. Vincent'S University Hospital
Dublin 4, Ireland	Completed
Soroka University Medical Center
Beer-sheva, Israel	Completed
Rambam Health Care Campus
Haifa, Israel	Completed
Hadassah University Hospital
Jerusalem, Israel	Completed
Rabin Medical Center - Beilinson Hospital
Petach Tikva, Israel	Completed
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel	Completed
Azienda Ospedaliero Universitaria Delle Marche
Ancona, Italy	Recruiting
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
Bari, Italy	Recruiting
Ospedale Papa Giovanni Xxiii
Bergamo, Italy	Completed
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, Italy	Recruiting
Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo
Candiolo, Italy	Recruiting
Presidio Ospedaliero Garibaldi Nesima
Catania, Italy	Completed
Ospedale Degli Infermi - Faenza
Faenza, Italy	Recruiting
Irccs Azienda Ospedaliera Universitaria San Martino
Genova, Italy	Recruiting
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Italy	Recruiting
European Institute of Oncology
Milan, Italy	Completed
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
Milan, Italy	Recruiting
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
Milano, Italy	Recruiting
A.O.U. Di Modena - Policlinico
Modena, Italy	Recruiting
Istituto Nazionale Tumori Irccs Fondazione Pascale
Napoli, Italy	Recruiting
Universita Degli Studi Della Campania Luigi Vanvitelli U.O.C. Oncologia Medica
Napoli, Italy	Recruiting
Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano
Orbassano, Italy	Completed
Iov - Istituto Oncologico Veneto Irccs
Padova, Italy	Recruiting
Presidio Ospedaliero Pescara
Pescara, Italy	Completed
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy	Recruiting
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Roma, Italy	Recruiting
Istituto Nazionale Tumori Regina Elena Irccs
Roma, Italy	Completed
Azienda Ospedaliera San Camillo Forlanini
Rome, Italy	Recruiting
Universita Campus Bio Medico Di Roma
Rome, Italy	Completed
Irccs Istituto Clinico Humanitas
Rozzano, Italy	Recruiting
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
Siena, Italy	Recruiting
Centro Ricerche Cliniche Di Verona (Crc)
Verona, Italy	Recruiting
San Bartolo Hospital
Vicenza, Italy	Recruiting
University of Tokyo Hospital
Bunkyo, Japan	Recruiting
Chiba University Hospital
Chiba, Japan	Recruiting
Chiba Cancer Center
Chiba-shi, Japan	Completed
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan	Recruiting
Kyushu University Hospital
Fukuoka-shi, Japan	Completed
Hiroshima University Hospital
Hiroshima-shi, Japan	Completed
Hyogo College of Medicine Hospital
Hyogo, Japan	Completed
Kanazawa University Hospital
Ishikawa, Japan	Recruiting
Teikyo University Hospital
Itabashi-ku, Japan	Not yet recruiting
Kobe University Hospital
Kobe-shi, Japan	Completed
Cancer Institute Hospital of Jfcr
Koto-ku, Japan	Recruiting
Kyoto University Hospital
Kyoto-shi, Japan	Completed
Nho Shikoku Cancer Center
Matsuyama-shi, Japan	Completed
Kyorin University Hospital
Mitaka-shi, Japan	Completed
Aichi Cancer Center Hospital
Nagoya-shi, Japan	Completed
Niigata Cancer Center Hospital
Niigata, Japan	Completed
Osaka International Cancer Institute
Osaka-shi, Japan	Recruiting
Kindai University Hospital
Osakasayama City, Japan	Completed
Saitama Cancer Center
Saitama, Japan	Recruiting
Hokkaido University Hospital
Sapporo-shi, Japan	Completed
Tohoku University Hospital
Sendai-shi, Japan	Completed
Jichi Medical University Hospital
Shimotsuke-shi, Japan	Completed
Keio University Hospital
Shinjuku-ku, Japan	Recruiting
Shizuoka Cancer Center
Shizuoka, Japan	Recruiting
Osaka University Hospital
Suita-shi, Japan	Completed
Toyama University Hospital
Toyama-shi, Japan	Completed
Yamaguchi University Hospital
UBE, Japan	Recruiting
Wakayama Medical University Hospital
Wakayama, Japan	Recruiting
Kanagawa Cancer Center
Yokohama-shi, Japan	Recruiting
Yokohama City University Medical Center
Yokohama-shi, Japan	Completed
Oita University Hospital
Yufu-shi, Japan	Completed
Amsterdam University Medical Centre
Amsterdam, Netherlands	Recruiting
Maastricht Umc+
Maastricht, Netherlands	Recruiting
Erasmus Medical Center
Rotterdam, Netherlands	Recruiting
Umc Utrecht
Utrecht, Netherlands	Recruiting
Oslo University Hospital
Oslo, Norway	Completed
Hospital Clinic Barcelona Main
Barcelona, Spain	Recruiting
Hospital Clinic Barcelona Main
Barcelona, Spain	Recruiting
Hospital General Universitario Vall D Hebron
Barcelona, Spain	Recruiting
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain	Completed
Hospital Universitario Reina Sofia
Cordoba, Spain	Recruiting
Hospital Universitario Reina Sofia
Córdoba, Spain	Recruiting
Hospital Materno Teresa Herrera
La Coruña, Spain	Recruiting
Hospital General Universitario Gregorio Maranon
Madrid, Spain	Recruiting
Hospital Universitario Hm Sanchinarro
Madrid, Spain	Completed
Hospital Universitario Ramon Y Cajal
Madrid, Spain	Completed
Hospital Regional Universitario de Malaga
Málaga, Spain	Recruiting
Clinica Universidad de Navarra (Cun)
Pamplona, Spain	Completed
Hospital Universitari Parc Tauli
Sabadell, Spain	Completed
HOSPITAL UNiVERSITARIO DONOSTIA
San Sebastian, Spain	Recruiting
Hospital Universitario Marques de Valdecilla
Santander, Spain	Completed
Hospital General Universitario de Valencia
Valencia, Spain	Recruiting
Sahlgrenska University Hospital
Göteborg, Sweden	Withdrawn
Karolinska Institute Universitetssjukhuset Solna
Solna, Sweden	Recruiting
Inselspital - Universitaetsspital Bern
Bern, Switzerland	Recruiting
Universitatsspital Zurich
Zuerich, Switzerland	Completed
Aberdeen Royal Infirmary
Aberdeen, United Kingdom	Completed
Addenbrooke'S Hospital
Cambridge, United Kingdom	Recruiting
Velindre Cancer Centre
Cardiff, United Kingdom	Completed
University Hospital Coventry and Warwickshire
Coventry, United Kingdom	Recruiting
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London, United Kingdom	Recruiting
The Royal Marsden Nhs Foundation Trust - Chelsea
London, United Kingdom	Recruiting
University College London Hospitals (Uclh)
London, United Kingdom	Recruiting
Kent Oncology Centre - Maidstone Hospital
Maidstone, United Kingdom	Completed
The Christie Nhs Foundation Trust
Manchester, United Kingdom	Recruiting
The Royal Marsden Nhs Foundation Trust - Sutton
Sutton, United Kingdom	Recruiting

Inclusion Criteria

» Male and female participants at least 18 years of age at the time of signing the informed consent form (ICF).

» Histologically or cytologically confirmed cholangiocarcinoma that is previously untreated and considered unresectable and/or metastatic (Stage IV per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual).

» Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1 criteria.

» Eastern Cooperative Oncology Group performance status 0 to 1.

» Documented FGFR2 rearrangement.

» Willingness to avoid pregnancy or fathering children.

Exclusion Criteria

» Received prior anticancer systemic therapy for unresectable and/or metastatic disease (not including adjuvant/neo-adjuvant treatment completed at least 6 months prior to enrollment, and participants that have received treatment for locally advanced disease with trans-arterial chemoembolization or selective internal radiation therapy, if clear evidence of radiological progression is observed before enrollment, or enrolled as of Amendment 6 (or Amendment 5-JP2) and the participant received 1 cycle of gemcitabine plus cisplatin [the start of study drug {Cycle 1 Day 1} must be at least 14 days and ≤ 4 weeks {28 days} from the last dose of gemcitabine plus cisplatin]).

» Child-Pugh B and C.

» Toxicities related to prior therapy(ies) must be Common Terminology Criteria for Adverse Events (CTCAE) v5.0 ≤ Grade 1 at the time of screening.

» Concurrent anticancer therapy, other than the therapies being tested in this study.

» Participant is a candidate for potentially curative surgery.

» Current evidence of clinically significant corneal (including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis) or retinal disorder (including but not limited to central serous retinopathy, macular/retinal degeneration, diabetic retinopathy, retinal detachment) as confirmed by ophthalmologic examination.

» Radiation therapy administered within 4 weeks of enrollment/randomization/first dose of study treatment.

» Known central nervous system (CNS) metastases or history of uncontrolled seizures.

» Known additional malignancy that is progressing or requires active treatment (exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy).

» Laboratory values at screening outside the protocol-defined range.

» History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues (exception: commonly observed calcifications in soft tissues, such as the skin, kidney, tendons or vessels due to injury, disease, and aging, in the absence of systemic mineral imbalance).

» Significant gastrointestinal disorders that could interfere with absorption, metabolism, or excretion of pemigatinib.

» Clinically significant or uncontrolled cardiac disease.

» History or presence of an abnormal ECG, which, in the investigator's opinion, is clinically meaningful.

» Chronic or current active infectious disease requiring systemic antibiotics or antifungal or antiviral treatment within 2 weeks prior to enrollment (participants with asymptomatic chronic infections on prophylactic treatment are allowed). Note: HIV-positive participants are allowed if all of the following criteria are met: CD4+ count ≥ 300/µL, undetectable viral load, receiving antiretroviral therapy that does not interact with study drug, and no HIV/AIDS-associated opportunistic infection in the last 12 months.

» Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment. Note: Moderate CYP3A4 inhibitors are not prohibited

» Known hypersensitivity or severe reaction to pemigatinib, gemcitabine, cisplatin, or their excipients.

» Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.