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A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma (FIGHT-302)

Primary Purpose

Unresectable Cholangiocarcinoma, Metastatic Cholangiocarcinoma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pemigatinib
Gemcitabine
Cisplatin
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unresectable Cholangiocarcinoma focused on measuring Cholangiocarcinoma, fibroblast growth factor receptor inhibitor, FGFR, FGFR rearrangement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic ArizonaRecruiting
  • Marin Cancer Care
  • Georgetown University-Lombardi Comprehensive Cancer Center
  • Mayo Clinic-FloridaRecruiting
  • Mount Sinai Medical Center Comprehensive Cancer CenterRecruiting
  • Winship Cancer Institute of Emory University
  • University of Chicago Medical Center
  • Parkview Research Center
  • University of Iowa Hospital and Clinics
  • The University of Kansas Cancer Center
  • Ochsner Clinic Foundation Ocf Ochsner Cancer Institute Oci
  • Johns Hopkins Oncology Center
  • Boston Medical Center
  • Beth Israel Deaconess Medical CenterRecruiting
  • Barbara Ann Karmanos Cancer HospitalRecruiting
  • Henry Ford Hospital
  • Karmanos Cancer InstituteRecruiting
  • Mayo ClinicRecruiting
  • Comprehensive Cancer Centers of Nevada-Twain
  • Summit Medical GroupRecruiting
  • Icahn School of Medicine At Mount SinaiRecruiting
  • White Plains Hospital
  • University Hospitals Cleveland Medical Center
  • Cleveland Clinic Foundation
  • Providence Portland Med. CtrRecruiting
  • Oregon Health & Science University
  • Fox Chase Cancer CenterRecruiting
  • Greenville Hospital System University Medical Center Institute For Translational Oncology Research
  • Baylor Scott and White Research InstituteRecruiting
  • Houston Methodist Research InstituteRecruiting
  • Riverside Regional Medical Center
  • Virginia Commonwealth University
  • Virginia Mason Medical CenterRecruiting
  • West Virginia University Cancer Institute
  • Aurora Research InstituteRecruiting
  • Landeskrankenhaus Universitatsklinikum Graz
  • Innsbruck University HospitalRecruiting
  • Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz
  • Salzburger UniversitatsklinikumRecruiting
  • Landeskrankenhaus Steyr
  • Allgemeines Krankenhaus Der Stadt WienRecruiting
  • Ulb Hospital ErasmeRecruiting
  • Universitair Ziekenhuis Brussel
  • Universitair Ziekenhuis GentRecruiting
  • Hospital de Jolimont
  • Az Groeninge Campus Kennedylaan
  • Universitaire Ziekenhuis Leuven - GasthuisbergRecruiting
  • Chu Ucl Namur University Hospital Mont-Godinne
  • Tom Baker Cancer Centre
  • Cancercare Manitoba
  • Nova Scotia Health Authority/Qeii Health Sciences CentreRecruiting
  • Princess Margaret Cancer CenterRecruiting
  • McGill University Health Centre Research Institute
  • Peking Union Medical College HospitalRecruiting
  • West China Hospital Sichuan UniversityRecruiting
  • Fujian Cancer HospitalRecruiting
  • Sun Yat-Sen Memorial Hospital Sun Yat-Sen UniversityRecruiting
  • Sun Yat-Sen Memorial Hospital Sun Yat-Sen UniversityRecruiting
  • Shulan Hangzhou Hospital Co LtdRecruiting
  • The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
  • Heilongjiang Province Cancer HospitalRecruiting
  • University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)Recruiting
  • Kunming 1St People'S HospitalRecruiting
  • Jiangsu Province HospitalRecruiting
  • The Affiliated Hospital of Qingdao UniversityRecruiting
  • Zhongshan Hospital Fudan UniversityRecruiting
  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
  • Xinhua HospitalRecruiting
  • Sichuan Cancer HospitalRecruiting
  • Tianjin Medical University Cancer Institute HospitalRecruiting
  • Tongji Hospital Huazhong University of Science and TechnologyRecruiting
  • Hubei Cancer HospitalRecruiting
  • Northern Jiangsu Peoples HospitalRecruiting
  • Herlev Og Gentofte Hospital
  • Docrates Cancer Center
  • Helsinki University Central Hospital
  • Tampere University Hospital
  • Institut Sainte CatherineRecruiting
  • Chu Besancon Hospital Jean MinjozRecruiting
  • Institut Bergonie
  • Hopital BeaujonRecruiting
  • Chu de Limoges - Hospital Dupuytren
  • Hopital Prive Jean Mermoz
  • Chu Hopital de La TimoneRecruiting
  • Centre Hospitalier Universitaire de Nantes
  • Centre Antoine Laccassagne
  • Hospital Universitaire Pitie-SalpetriereRecruiting
  • Hopital Europeen Georges Pompidou (Hegp)Recruiting
  • Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-LevequeRecruiting
  • Hospital de La MiletrieRecruiting
  • Hopital Charles Nicolle Chu Rouen Hospital de Bois-GuillaumeRecruiting
  • University Hospital of Saint EtienneRecruiting
  • Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene GauducheauRecruiting
  • Chu Toulouse Hopital Rangueil
  • Chu Vandoeuvre-Les-Nancy Hopital BraboisRecruiting
  • Institut Gustave RoussyRecruiting
  • University Medical Center Rwth AachenRecruiting
  • Charite - Campus Virchow-KlinikumRecruiting
  • Charite Universitaetsmedizin Berlin - Campus Charite MitteRecruiting
  • Universitatsklinikum Bonn AoerRecruiting
  • Klinikum Bremen-Nord
  • University Clinic Carl Gustav Carus Technical University DresdenRecruiting
  • Klinikum Der Johann Wolfgang Goethe UniversityRecruiting
  • University Medical Center Freiburg
  • Universitatsklinikum Hamburg EppendorfRecruiting
  • Asklepios Klinik AltonaRecruiting
  • Hannover Medical SchoolRecruiting
  • Universitaetsklinikum Des Saarlandes
  • Universitatsklinikum KolnRecruiting
  • Universitatsklinikum Leipzig Aor
  • Klinikum Ludwigsburg
  • Otto-Von-Guericke-Universitat MagdeburgRecruiting
  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
  • University Hospital Grosshadern MunichRecruiting
  • Klinikum NuernbergRecruiting
  • Universitaetsklinikum in TubingenRecruiting
  • University Hospital TuebingenRecruiting
  • Universitatkinikums UlmRecruiting
  • St. Vincent'S University Hospital
  • Soroka University Medical Center
  • Rambam Health Care Campus
  • Hadassah University Hospital
  • Rabin Medical Center - Beilinson Hospital
  • Tel Aviv Sourasky Medical Center
  • Azienda Ospedaliero Universitaria Ospedali RiunitiRecruiting
  • Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico BariRecruiting
  • Ospedale Papa Giovanni Xxiii
  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola MalpighiRecruiting
  • Fondazione Del Piemonte Per L'Oncologia Ircc CandioloRecruiting
  • Presidio Ospedaliero Garibaldi Nesima
  • Ospedale Degli Infermi - FaenzaRecruiting
  • Irccs Azienda Ospedaliera Universitaria San MartinoRecruiting
  • Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori MilanoRecruiting
  • Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San RaffaeleRecruiting
  • European Institute of Oncology
  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano NiguardaRecruiting
  • A.O.U. Di Modena - PoliclinicoRecruiting
  • Istituto Nazionale Tumori Irccs Fondazione PascaleRecruiting
  • Universita Degli Studi Della Campania Luigi Vanvitelli U.O.C. Oncologia MedicaRecruiting
  • Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano
  • Iov - Istituto Oncologico Veneto IrccsRecruiting
  • Presidio Ospedaliero Pescara
  • Azienda Ospedaliera Universitaria PisanaRecruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IrccsRecruiting
  • Istituto Nazionale Tumori Regina Elena Irccs
  • Universita Campus Bio Medico Di Roma
  • Azienda Ospedaliera San Camillo ForlaniniRecruiting
  • Irccs Istituto Clinico HumanitasRecruiting
  • Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle ScotteRecruiting
  • Centro Ricerche Cliniche Di Verona (Crc)Recruiting
  • San Bartolo HospitalRecruiting
  • University of Tokyo HospitalRecruiting
  • Chiba University HospitalRecruiting
  • Chiba Cancer CenterRecruiting
  • National Hospital Organization Kyushu Cancer CenterRecruiting
  • National Hospital Organization Kyushu Cancer CenterRecruiting
  • Hiroshima University Hospital
  • Hokkaido University HospitalRecruiting
  • Hyogo College of Medicine Hospital
  • Kanazawa University HospitalRecruiting
  • Teikyo University Hospital
  • Kobe University Hospital
  • Cancer Institute Hospital of JfcrRecruiting
  • Kyoto University Hospital
  • Nho Shikoku Cancer Center
  • Kyorin University Hospital
  • Aichi Cancer Center Hospital
  • Niigata Cancer Center Hospital
  • Osaka International Cancer InstituteRecruiting
  • Kindai University Hospital
  • Saitama Cancer CenterRecruiting
  • Tohoku University Hospital
  • Jichi Medical University Hospital
  • Keio University HospitalRecruiting
  • Shizuoka Cancer CenterRecruiting
  • Osaka University HospitalRecruiting
  • Toyama University HospitalRecruiting
  • Yamaguchi University HospitalRecruiting
  • Wakayama Medical University HospitalRecruiting
  • Yokohama City University Medical Center
  • Kanagawa Cancer CenterRecruiting
  • Oita University Hospital
  • Amsterdam University Medical CentreRecruiting
  • Maastricht Umc+Recruiting
  • Erasmus Medical CenterRecruiting
  • Umc UtrechtRecruiting
  • Oslo University Hospital
  • Hospital de La Santa Creu I Sant Pau
  • Hospital General Universitario Vall D HebronRecruiting
  • Hospital Clinic Barcelona MainRecruiting
  • Hospital Clinic Barcelona MainRecruiting
  • Hospital Universitario Reina SofiaRecruiting
  • Hospital Universitario Reina SofiaRecruiting
  • Hospital Materno Teresa HerreraRecruiting
  • Hospital General Universitario Gregorio MaranonRecruiting
  • Hospital Universitario Ramon Y Cajal
  • Hospital Universitario Hm Sanchinarro
  • Hospital Regional Universitario de MalagaRecruiting
  • Clinica Universidad de Navarra (Cun)
  • Hospital Universitari Parc Tauli
  • HOSPITAL UNiVERSITARIO DONOSTIARecruiting
  • Hospital Universitario Marques de Valdecilla
  • Hospital General Universitario de ValenciaRecruiting
  • Sahlgrenska University Hospital
  • Karolinska Institute Universitetssjukhuset SolnaRecruiting
  • Inselspital - Universitaetsspital BernRecruiting
  • Universitatsspital Zurich
  • Aberdeen Royal Infirmary
  • Addenbrooke'S HospitalRecruiting
  • Velindre Cancer Centre
  • University Hospital Coventry and WarwickshireRecruiting
  • The Royal Marsden Nhs Foundation Trust - ChelseaRecruiting
  • Imperial College Healthcare Nhs Trust - Hammersmith HospitalRecruiting
  • University College London Hospitals (Uclh)Recruiting
  • Kent Oncology Centre - Maidstone Hospital
  • The Christie Nhs Foundation TrustRecruiting
  • The Royal Marsden Nhs Foundation Trust - SuttonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pemigatinib

Gemcitabine + Cisplatin

Arm Description

Participants who experience disease progression while receiving gemcitabine + cisplatin or during the follow-up period and before starting a new anticancer therapy will be eligible to cross over and receive pemigatinib.

Outcomes

Primary Outcome Measures

Progression-free survival
Defined as the time from date of randomization until date of disease progression (according to Response Evaluation Criteria in Solid Tumors [RECIST] v1.1 and assessed by an independent central reviewer (ICR)) or death, whichever occurs first.

Secondary Outcome Measures

Overall response rate
Defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by an ICR.
Overall survival
Defined as the time from date of randomization until death due to any cause.
Duration of response
Defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression by an ICR per RECIST v1.1 or death, whichever occurs first.
Disease control rate
Defined as the proportion of participants who achieved best overall response of CR, PR, or stable disease (SD) per RECIST v1.1 as assessed by an ICR.
Number of treatment-emergent adverse events
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Quality of Life impact as assessed by the EQ-5D-3L questionnaire
Quality of Life impact as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire
Quality of Life impact as assessed by the EORTC QLQ-BIL21 questionnaire

Full Information

First Posted
August 29, 2018
Last Updated
October 3, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03656536
Brief Title
A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma
Acronym
FIGHT-302
Official Title
A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study 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 (FIGHT-302)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2019 (Actual)
Primary Completion Date
October 26, 2027 (Anticipated)
Study Completion Date
July 27, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Cholangiocarcinoma, Metastatic Cholangiocarcinoma
Keywords
Cholangiocarcinoma, fibroblast growth factor receptor inhibitor, FGFR, FGFR rearrangement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
434 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pemigatinib
Arm Type
Experimental
Arm Title
Gemcitabine + Cisplatin
Arm Type
Active Comparator
Arm Description
Participants who experience disease progression while receiving gemcitabine + cisplatin or during the follow-up period and before starting a new anticancer therapy will be eligible to cross over and receive pemigatinib.
Intervention Type
Drug
Intervention Name(s)
Pemigatinib
Other Intervention Name(s)
INCB054828
Intervention Description
Pemigatinib at the protocol-defined dose administered orally once daily as continuous therapy schedule (a cycle is 3 weeks).
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine 1000 mg/m^2 administered as an intravenous infusion on Days 1 and 8 of every 3-week cycle for up to 8 cycles.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin 25 mg/m^2 administered as an intravenous infusion on Days 1 and 8 of every 3-week cycle for up to 8 cycles.
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Defined as the time from date of randomization until date of disease progression (according to Response Evaluation Criteria in Solid Tumors [RECIST] v1.1 and assessed by an independent central reviewer (ICR)) or death, whichever occurs first.
Time Frame
Up to approximately 12 months
Secondary Outcome Measure Information:
Title
Overall response rate
Description
Defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by an ICR.
Time Frame
Up to approximately 12 months
Title
Overall survival
Description
Defined as the time from date of randomization until death due to any cause.
Time Frame
Up to approximately 12 months
Title
Duration of response
Description
Defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression by an ICR per RECIST v1.1 or death, whichever occurs first.
Time Frame
Up to approximately 12 months
Title
Disease control rate
Description
Defined as the proportion of participants who achieved best overall response of CR, PR, or stable disease (SD) per RECIST v1.1 as assessed by an ICR.
Time Frame
Up to approximately 12 months
Title
Number of treatment-emergent adverse events
Description
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time Frame
Up to approximately 12 months
Title
Quality of Life impact as assessed by the EQ-5D-3L questionnaire
Time Frame
Up to 12 months
Title
Quality of Life impact as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire
Time Frame
Up to 12 months
Title
Quality of Life impact as assessed by the EORTC QLQ-BIL21 questionnaire
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (US)
Phone
1.855.463.3463
Email
medinfo@incyte.com
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (ex-US)
Phone
+800 00027423
Email
globalmedinfo@incyte.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Langmuir, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
480-342-6029
Facility Name
Marin Cancer Care
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Individual Site Status
Completed
Facility Name
Georgetown University-Lombardi Comprehensive Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Completed
Facility Name
Mayo Clinic-Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
904-953-3814
Facility Name
Mount Sinai Medical Center Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
305-674-2625
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Completed
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1447
Country
United States
Individual Site Status
Completed
Facility Name
Parkview Research Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Individual Site Status
Completed
Facility Name
University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Completed
Facility Name
The University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Completed
Facility Name
Ochsner Clinic Foundation Ocf Ochsner Cancer Institute Oci
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Completed
Facility Name
Johns Hopkins Oncology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Completed
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Completed
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Barbara Ann Karmanos Cancer Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
313-576-8496
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Completed
Facility Name
Karmanos Cancer Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
714-456-6210
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
507-284-2030
Facility Name
Comprehensive Cancer Centers of Nevada-Twain
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Individual Site Status
Completed
Facility Name
Summit Medical Group
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
973-436-1755
Facility Name
Icahn School of Medicine At Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
White Plains Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
Individual Site Status
Completed
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Completed
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Completed
Facility Name
Providence Portland Med. Ctr
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
503-215-9570
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Completed
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
215-214-1660
Facility Name
Greenville Hospital System University Medical Center Institute For Translational Oncology Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Completed
Facility Name
Baylor Scott and White Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
214-820-6168
Facility Name
Houston Methodist Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Riverside Regional Medical Center
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States
Individual Site Status
Completed
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
206-287-5671
Facility Name
West Virginia University Cancer Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Completed
Facility Name
Aurora Research Institute
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
Landeskrankenhaus Universitatsklinikum Graz
City
Graz
ZIP/Postal Code
08036
Country
Austria
Individual Site Status
Completed
Facility Name
Innsbruck University Hospital
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz
City
Linz
ZIP/Postal Code
04010
Country
Austria
Individual Site Status
Completed
Facility Name
Salzburger Universitatsklinikum
City
Salzburg
ZIP/Postal Code
05020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Landeskrankenhaus Steyr
City
Steyr
ZIP/Postal Code
04400
Country
Austria
Individual Site Status
Completed
Facility Name
Allgemeines Krankenhaus Der Stadt Wien
City
Vienna
ZIP/Postal Code
01090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Ulb Hospital Erasme
City
Bruxelles
ZIP/Postal Code
01070
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Brussel
City
Bruxelles
ZIP/Postal Code
01090
Country
Belgium
Individual Site Status
Completed
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
09000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Hospital de Jolimont
City
Haine-st-paul
ZIP/Postal Code
07100
Country
Belgium
Individual Site Status
Completed
Facility Name
Az Groeninge Campus Kennedylaan
City
Kortrijk
ZIP/Postal Code
08500
Country
Belgium
Individual Site Status
Completed
Facility Name
Universitaire Ziekenhuis Leuven - Gasthuisberg
City
Leuven
ZIP/Postal Code
03000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Chu Ucl Namur University Hospital Mont-Godinne
City
Yvoir
ZIP/Postal Code
05530
Country
Belgium
Individual Site Status
Completed
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Cancercare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Nova Scotia Health Authority/Qeii Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 4K4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
MG5 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
McGill University Health Centre Research Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Cancer Hospital
City
Fuzhou
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
City
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
City
Guangzhou
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Name
Shulan Hangzhou Hospital Co Ltd
City
Hangzhou
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Name
Heilongjiang Province Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Name
University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)
City
Hefei
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Name
Kunming 1St People'S Hospital
City
Kunming
ZIP/Postal Code
650032
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangsu Province Hospital
City
Nanjing
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Qingdao University
City
Shandong
ZIP/Postal Code
266071
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Name
Xinhua Hospital
City
SHanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Name
Sichuan Cancer Hospital
City
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University Cancer Institute Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Hubei Cancer Hospital
City
Wuhan
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Name
Northern Jiangsu Peoples Hospital
City
Yangzhou
ZIP/Postal Code
225001
Country
China
Individual Site Status
Recruiting
Facility Name
Herlev Og Gentofte Hospital
City
Herlev
ZIP/Postal Code
02730
Country
Denmark
Individual Site Status
Completed
Facility Name
Docrates Cancer Center
City
Helsinki
ZIP/Postal Code
00180
Country
Finland
Individual Site Status
Completed
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Individual Site Status
Completed
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Individual Site Status
Completed
Facility Name
Institut Sainte Catherine
City
Avignon Cedex 9
ZIP/Postal Code
84918
Country
France
Individual Site Status
Recruiting
Facility Name
Chu Besancon Hospital Jean Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Bergonie
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Individual Site Status
Completed
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Individual Site Status
Recruiting
Facility Name
Chu de Limoges - Hospital Dupuytren
City
Limoges Cedex
ZIP/Postal Code
87042
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hopital Prive Jean Mermoz
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Individual Site Status
Completed
Facility Name
Chu Hopital de La Timone
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre Antoine Laccassagne
City
Nice Cedex 02
ZIP/Postal Code
06189
Country
France
Individual Site Status
Completed
Facility Name
Hospital Universitaire Pitie-Salpetriere
City
Paris Cedex 13
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Europeen Georges Pompidou (Hegp)
City
Paris Cedex 15
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque
City
Pessac Cedex
ZIP/Postal Code
336600
Country
France
Individual Site Status
Recruiting
Facility Name
Hospital de La Miletrie
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Name
University Hospital of Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Name
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
City
Saint Herblain
ZIP/Postal Code
44800
Country
France
Individual Site Status
Recruiting
Facility Name
Chu Toulouse Hopital Rangueil
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Individual Site Status
Completed
Facility Name
Chu Vandoeuvre-Les-Nancy Hopital Brabois
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
University Medical Center Rwth Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charite - Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Bonn Aoer
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Bremen-Nord
City
Bremen
ZIP/Postal Code
28755
Country
Germany
Individual Site Status
Completed
Facility Name
University Clinic Carl Gustav Carus Technical University Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Der Johann Wolfgang Goethe University
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Medical Center Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Completed
Facility Name
Universitatsklinikum Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Name
Asklepios Klinik Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Individual Site Status
Recruiting
Facility Name
Hannover Medical School
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Des Saarlandes
City
Homburg / Saar
ZIP/Postal Code
66421
Country
Germany
Individual Site Status
Completed
Facility Name
Universitatsklinikum Koln
City
Koln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Leipzig Aor
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Completed
Facility Name
Klinikum Ludwigsburg
City
Ludwigsburg
ZIP/Postal Code
71640
Country
Germany
Individual Site Status
Completed
Facility Name
Otto-Von-Guericke-Universitat Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Completed
Facility Name
University Hospital Grosshadern Munich
City
Munich
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Nuernberg
City
Nuernberg
ZIP/Postal Code
90419
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum in Tubingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital Tuebingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatkinikums Ulm
City
ULM
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
St. Vincent'S University Hospital
City
Dublin 4
ZIP/Postal Code
D04 Y8V0
Country
Ireland
Individual Site Status
Completed
Facility Name
Soroka University Medical Center
City
Beer-sheva
ZIP/Postal Code
84001
Country
Israel
Individual Site Status
Completed
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Completed
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Completed
Facility Name
Rabin Medical Center - Beilinson Hospital
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Completed
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Completed
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390715965093
Facility Name
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390805555442
Facility Name
Ospedale Papa Giovanni Xxiii
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Completed
Facility Name
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Recruiting
Facility Name
Presidio Ospedaliero Garibaldi Nesima
City
Catania
ZIP/Postal Code
95100
Country
Italy
Individual Site Status
Completed
Facility Name
Ospedale Degli Infermi - Faenza
City
Faenza
ZIP/Postal Code
48018
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390546601194
Facility Name
Irccs Azienda Ospedaliera Universitaria San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390105553977
Facility Name
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390223903835
Facility Name
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
European Institute of Oncology
City
Milan
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Completed
Facility Name
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
City
Milan
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39024442291
Facility Name
A.O.U. Di Modena - Policlinico
City
Modena
ZIP/Postal Code
41124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+393929175678
Facility Name
Istituto Nazionale Tumori Irccs Fondazione Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Universita Degli Studi Della Campania Luigi Vanvitelli U.O.C. Oncologia Medica
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390815666688
Facility Name
Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Completed
Facility Name
Iov - Istituto Oncologico Veneto Irccs
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Presidio Ospedaliero Pescara
City
Pescara
ZIP/Postal Code
65124
Country
Italy
Individual Site Status
Completed
Facility Name
Azienda Ospedaliera Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli Irccs
City
Roma
ZIP/Postal Code
00137
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+393498756270
Facility Name
Istituto Nazionale Tumori Regina Elena Irccs
City
Roma
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Completed
Facility Name
Universita Campus Bio Medico Di Roma
City
Rome
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Completed
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Rome
ZIP/Postal Code
00152
Country
Italy
Individual Site Status
Recruiting
Facility Name
Irccs Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39577586335
Facility Name
Centro Ricerche Cliniche Di Verona (Crc)
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39458126564
Facility Name
San Bartolo Hospital
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3904325521
Facility Name
University of Tokyo Hospital
City
Bunkyo
ZIP/Postal Code
113-8655
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81338155411
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81432262630
Facility Name
Chiba Cancer Center
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81342183500
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka-shi
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81926411151
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81925413231
Facility Name
Hiroshima University Hospital
City
Hiroshima-shi
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Completed
Facility Name
Hokkaido University Hospital
City
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81117067600
Facility Name
Hyogo College of Medicine Hospital
City
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Individual Site Status
Completed
Facility Name
Kanazawa University Hospital
City
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81762652049
Facility Name
Teikyo University Hospital
City
Itabashi-ku
ZIP/Postal Code
173-8606
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Kobe University Hospital
City
Kobe-shi
ZIP/Postal Code
650-0017
Country
Japan
Individual Site Status
Completed
Facility Name
Cancer Institute Hospital of Jfcr
City
Koto-ku
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81363164620
Facility Name
Kyoto University Hospital
City
Kyoto-shi
ZIP/Postal Code
606-8507
Country
Japan
Individual Site Status
Completed
Facility Name
Nho Shikoku Cancer Center
City
Matsuyama-shi
ZIP/Postal Code
791-0280
Country
Japan
Individual Site Status
Completed
Facility Name
Kyorin University Hospital
City
Mitaka-shi
ZIP/Postal Code
181-8611
Country
Japan
Individual Site Status
Completed
Facility Name
Aichi Cancer Center Hospital
City
Nagoya-shi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Completed
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Completed
Facility Name
Osaka International Cancer Institute
City
Osaka-shi
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81662026677
Facility Name
Kindai University Hospital
City
Osakasayama City
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Completed
Facility Name
Saitama Cancer Center
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81355755862
Facility Name
Tohoku University Hospital
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Completed
Facility Name
Jichi Medical University Hospital
City
Shimotsuke-shi
ZIP/Postal Code
329-0498
Country
Japan
Individual Site Status
Completed
Facility Name
Keio University Hospital
City
Shinjuku-ku
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81353633899
Facility Name
Shizuoka Cancer Center
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81559895222
Facility Name
Osaka University Hospital
City
Suita-shi
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81367215432
Facility Name
Toyama University Hospital
City
Toyama
ZIP/Postal Code
930-0194
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81776245900
Facility Name
Yamaguchi University Hospital
City
UBE
ZIP/Postal Code
755-8505
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81825061631
Facility Name
Wakayama Medical University Hospital
City
Wakayama
ZIP/Postal Code
641-8509
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama City University Medical Center
City
Yokohama-shi
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Completed
Facility Name
Kanagawa Cancer Center
City
Yokohama-shi
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Oita University Hospital
City
Yufu-shi
ZIP/Postal Code
879-5593
Country
Japan
Individual Site Status
Completed
Facility Name
Amsterdam University Medical Centre
City
Amsterdam
ZIP/Postal Code
1100 DD
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Maastricht Umc+
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+31433871197
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+31107034897
Facility Name
Umc Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+31887556263
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
00450
Country
Norway
Individual Site Status
Completed
Facility Name
Hospital de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08026
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital General Universitario Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34913368263
Facility Name
Hospital Clinic Barcelona Main
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34932275400
Ext
3303
Facility Name
Hospital Clinic Barcelona Main
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34957011893
Facility Name
Hospital Materno Teresa Herrera
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34981178000
Ext
292872
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34914269629
Facility Name
Hospital Universitario Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario Hm Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Regional Universitario de Malaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34951291425
Facility Name
Clinica Universidad de Navarra (Cun)
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitari Parc Tauli
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Completed
Facility Name
HOSPITAL UNiVERSITARIO DONOSTIA
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34943006032
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Sahlgrenska University Hospital
City
Göteborg
ZIP/Postal Code
413 46
Country
Sweden
Individual Site Status
Withdrawn
Facility Name
Karolinska Institute Universitetssjukhuset Solna
City
Solna
ZIP/Postal Code
171 64
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+46851773484
Facility Name
Inselspital - Universitaetsspital Bern
City
Bern
ZIP/Postal Code
03010
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Universitatsspital Zurich
City
Zuerich
ZIP/Postal Code
08091
Country
Switzerland
Individual Site Status
Completed
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Addenbrooke'S Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441223348076
Facility Name
Velindre Cancer Centre
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Individual Site Status
Completed
Facility Name
University Hospital Coventry and Warwickshire
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Royal Marsden Nhs Foundation Trust - Chelsea
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+442086426011
Facility Name
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+442033131000
Facility Name
University College London Hospitals (Uclh)
City
London
ZIP/Postal Code
WC1E 6BT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Kent Oncology Centre - Maidstone Hospital
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Individual Site Status
Completed
Facility Name
The Christie Nhs Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BV
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441614468106
Facility Name
The Royal Marsden Nhs Foundation Trust - Sutton
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+442086426011

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency
Citations:
PubMed Identifier
32677452
Citation
Bekaii-Saab TS, Valle JW, Van Cutsem E, Rimassa L, Furuse J, Ioka T, Melisi D, Macarulla T, Bridgewater J, Wasan H, Borad MJ, Abou-Alfa GK, Jiang P, Lihou CF, Zhen H, Asatiani E, Feliz L, Vogel A. FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements. Future Oncol. 2020 Oct;16(30):2385-2399. doi: 10.2217/fon-2020-0429. Epub 2020 Jul 17.
Results Reference
derived

Learn more about this trial

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

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