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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03656536
Recruitment Status : Recruiting
First Posted : September 4, 2018
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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.

Condition or disease Intervention/treatment Phase
Unresectable Cholangiocarcinoma Metastatic Cholangiocarcinoma Drug: Pemigatinib Drug: Gemcitabine Drug: Cisplatin Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 13, 2018
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2024


Arm Intervention/treatment
Experimental: Pemigatinib Drug: Pemigatinib
Pemigatinib at the protocol-defined dose administered orally once daily as continuous therapy schedule (a cycle is 3 weeks).
Other Name: INCB054828

Active Comparator: Gemcitabine + Cisplatin
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.
Drug: Gemcitabine
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.

Drug: Cisplatin
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 Measures :
  1. Progression-free survival [ Time Frame: Up to approximately 12 months ]
    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 :
  1. Overall response rate [ Time Frame: Up to approximately 12 months ]
    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.

  2. Overall survival [ Time Frame: Up to approximately 12 months ]
    Defined as the time from date of randomization until death due to any cause.

  3. Duration of response [ Time Frame: Up to approximately 12 months ]
    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.

  4. Disease control rate [ Time Frame: Up to approximately 12 months ]
    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.

  5. Number of treatment-emergent adverse events [ Time Frame: Up to approximately 12 months ]
    Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

  6. Quality of Life impact as assessed by the EQ-5D-3L questionnaire [ Time Frame: Up to 12 months ]
  7. 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 ]
  8. Quality of Life impact as assessed by the EORTC QLQ-BIL21 questionnaire [ Time Frame: Up to 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female participants at least 18 years of age at the time of signing the informed consent form (ICF); a legally minor participant from Japan needs written parental consent.
  • 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).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656536


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

Locations
Hide Hide 154 study locations
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United States, Arizona
Mayo Clinic Arizona Recruiting
Phoenix, Arizona, United States, 85054
Contact: Study Coordinator    480-342-6029      
United States, California
Marin Cancer Care Recruiting
Greenbrae, California, United States, 94904
UC Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Study Coordinator    714-456-6210      
United States, District of Columbia
Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Study Coordinator    202-687-8974      
United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Study Coordinator    904-953-3814      
Mount Sinai Comprehensive Cancer Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Study Coordinator    305-674-2625      
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Study Coordinator    404-778-5419      
United States, Illinois
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Study Coordinator    773-702-7763      
United States, Indiana
Parkview Research Center Recruiting
Fort Wayne, Indiana, United States, 46845
Contact: Study Coordinator    260-266-6622      
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
The University of Kansas Cancer Center Recruiting
Westwood, Kansas, United States, 66205
Contact: Study Coordinator    913-588-1886      
United States, Louisiana
Ochsner Clinic Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Study Coordinator    504-842-3929      
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Study Coordinator    410-502-5327      
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Study Coordinator    617-975-7463      
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Study Coordinator    617-638-8213      
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Study Coordinator    313-576-8496      
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Study Coordinator    313-916-3721 ext 568756      
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Study Coordinator    507-284-2030      
United States, Nevada
Comprehensive Cancer Center of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Summit Medical Group PA Recruiting
Florham Park, New Jersey, United States, 07932
Contact: Study Coordinator    973-436-1755      
United States, New York
Mt. Sinai Hospital Recruiting
New York, New York, United States, 10029
White Plains Hospital Recruiting
New York, New York, United States, 10601
Contact: Study Coordinator    914-849-7591      
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Study Coordinator    503-215-9570      
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Study Coordinator    503-494-3175      
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Study Coordinator    215-214-1660      
United States, South Carolina
Greenville Health System Cancer Institute Recruiting
Greenville, South Carolina, United States, 29605
Contact: Study Coordinator    864-699-5731      
United States, Texas
Baylor University - Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Study Coordinator    214-820-6168      
Houston Methodist Research Institute Recruiting
Houston, Texas, United States, 77030
United States, Virginia
Peninsula Cancer Institute Recruiting
Newport News, Virginia, United States, 23601
Contact: Study Coordinator    757-534-5567      
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Study Coordinator    206-287-5671      
United States, West Virginia
West Virginia University Hospitals, Inc Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Study Coordinator    304-293-2633      
Austria
Medical University Innsbruck Recruiting
Innsbruck, Austria, 6020
Paracelsus Medical University Salzburg Recruiting
Salzburg, Austria, 5020
Landeskrankenhaus Steyr Recruiting
Steyr, Austria, 4400
Medizinische Universität Wien Recruiting
Wien, Austria, 1090
Belgium
ULB Hopital Erasme Recruiting
Brussels, Belgium, 1070
Contact: Study Coordinator    +3225553016      
UZ Gent Recruiting
Gent, Belgium, 9000
Contact: Study Coordinator    +3293325125      
AZ Groeninge Recruiting
Kortrijk, Belgium, 8500
Contact: Study Coordinator    +3256633338      
Hopital De Jolimont Recruiting
La Louviere, Belgium, 7100
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Study Coordinator    +3216341940      
CHU UCL Namur, University Hospital Mont-Godinne Recruiting
Yvoir, Belgium, 5530
Denmark
Herlev og Gentofte Hospital Recruiting
Herlev, Denmark, 2730
Finland
Docrates Cancer Center Recruiting
Helsinki, Finland, 00180
Contact: Study Coordinator    +358505001856      
Helsinki University Hospital Recruiting
Helsinki, Finland, 00290
Contact: Study Coordinator    +358505130234      
Tampere University Hospital Recruiting
Tampere, Finland, 33521
Contact: Study Coordinator    +3583311611      
France
Institut Sainte Catherine Recruiting
Avignon, France, 84918
Institut Bergonie Recruiting
Bordeaux, France, 33000
Hopital Beaujon Recruiting
Clichy, France, 92110
Hopital Prive Jean Mermoz Recruiting
Lyon, France, 69008
CHU Hopital De La Timone Recruiting
Marseille, France, 13385
Hopital Europeen Georges Pompidou Recruiting
Paris, France, 75015
Hopital Haut Leveque Recruiting
Pessac, France, 33604
CHU Poitiers - Hôpital la Milétrie Recruiting
Poitiers, France, 86021
CHU Nancy - Hopital Brabois Recruiting
Vandoeuvre-les-Nancy, France, 54500
Institute Gustave Roussy Recruiting
Villejuif, France, 94800
Germany
Klinikum Bremen-Nord Recruiting
Bremen, Germany, 28755
Universitaetsklinikum Freiburg Recruiting
Freiburg, Germany, 79106
Klinikum Ludwigsburg Recruiting
Ludwigsburg, Germany, 71640
Universitaetsklinikum Tubingen Recruiting
Tubingen, Germany, 72076
Ireland
St Vincent's University Hospital Recruiting
Dublin, Ireland, D04 Y8V0
Israel
Soroka Medical Center Recruiting
Be'er Sheva, Israel, 84101
Contact: Study Coordinator    +97286244068      
Rambam Health Care Campus Recruiting
Haifa, Israel, 3525-408
Hadassah University Hospital - Ein Kerem Recruiting
Jerusalem, Israel, 9112-001
Rabin Medical Center - Beilinson Hospital Recruiting
Petach Tikva, Israel, 4841-492
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Study Coordinator    +97236973021      
Italy
Azienda Ospedaliero Universitaria Ospedali Ruiniti Recruiting
Ancona, Italy, 60126
Contact: Study Coordinator    +390715965093      
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari Recruiting
Bari, Italy, 70124
Contact: Study Coordinator    +390805555442      
Ospedale Papa Giovanni XXIII Recruiting
Bergamo, Italy, 24127
Azienda Ospedaliero-Universitaria Di Bologna - Policlinico S. Orsola Malpighi Recruiting
Bologna, Italy, 40138
Fondazione Del Piemonte Per L'Oncologia IRCC Candiolo Recruiting
Candiolo, Italy, 10060
Presidio Ospedaliero Garibaldi Nesima Recruiting
Catania, Italy, 95100
Contact: Study Coordinator    +390957595936      
A.O.U Policlinico Vittorio Emanuele Recruiting
Catania, Italy, 95123
Ospedale Degli Infermi - Faenza Recruiting
Faenza, Italy, 48018
Contact: Study Coordinator    +390546601194      
IRCCS Azienda Ospedaliera Universitaria San Martino Recruiting
Genova, Italy, 16132
Contact: Study Coordinator    +390105553977      
Ospedale San Raffaele Recruiting
Milano, Italy, , 20132
Fondazione IRCCS Istituto Nazionale Dei Tumori Recruiting
Milano, Italy, 20133
Contact: Study Coordinator    +390223903835      
Istituto Europeo Di Oncologia Recruiting
Milano, Italy, 20141
Contact: Study Coordinator    +390294372680      
Grande Ospedale Metropolitano Niguarda Recruiting
Milano, Italy, 20162
Contact: Study Coordinator    +39024442291      
A.O.U Di Modena - Polclinico Recruiting
Modena, Italy, 41124
Contact: Study Coordinator    +393929175678      
Istituto Nazionale Tumori Fondazione IRCCS G. Pascale Recruiting
Naples, Italy, 80131
Universitaria Degli Studi Della Campania "Luigi Vanvitelli" U.O.C. Oncologia Medica Recruiting
Napoli, Italy, 80138
Contact: Study Coordinator    +390815666688      
Azienda Ospedaliera Universitia San Luigi Gonzaga Recruiting
Orbassano, Italy, 10043
IOV - Istituto Oncologico Veneto IRCCS Recruiting
Padova, Italy, 35128
Azienda Ospedaliera Universitia Pisana Recruiting
Pisa, Italy, 56126
Universita Campus Bio-Medico Di Roma Recruiting
Roma, Italy, 00128
Istituto Nazionale Tumori Regina Elena IRCCS Recruiting
Roma, Italy, 00144
Contact: Study Coordinator    +390652665330      
Policlinico Universitario Gemelli Recruiting
Rome, Italy, 00168
Contact: Study Coordinator    +393498756270      
IRRCS Instituto Clinico Humanitas Recruiting
Rozzano, Italy, 20089
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte Recruiting
Siena, Italy, 53100
Contact: Study Coordinator    +39577586335      
Azienda Ospedaliera di Verona-Policlinico G.B. Rossi Recruiting
Verona, Italy, 37134
Contact: Study Coordinator    +39458126564      
San Bartolo Hospital Recruiting
Vicenza, Italy, 36100
Contact: Study Coordinator    +3904325521      
Japan
Saitama Cancer Center Recruiting
Saitama, Kita Adachi-Gun, Japan, 362-0806
Contact: Study Coordinator    +81355755862      
Shizuoka Cancer Center Recruiting
Nagaizumi-chō, Sunto-gun, Japan, 411-8777
Contact: Study Coordinator    +81559895222      
Aichi Cancer Center Hospital Recruiting
Aichi, Japan, 4648681
Contact: Study Coordinator    +81525898730      
University of Tokyo Hospital Recruiting
Bunkyō-Ku, Japan, 113-8655
Contact: Study Coordinator    +81338155411      
Chiba University Hospital Recruiting
Chiba, Japan, 260-8677
Contact: Study Coordinator    +81432262630      
Chiba Cancer Center Recruiting
Chiba, Japan, 260-8717
Contact: Study Coordinator    +81342183500      
National Hospital Organization Kyushu Cancer Center Recruiting
Fukuoka-Shi, Japan, 811-1395
Contact: Study Coordinator    +81925413231      
Kyushu University Hospital Recruiting
Fukuoka, Japan, 812-8582
Contact: Study Coordinator    +81926411151      
Hiroshima University Hospital Recruiting
Hiroshima, Japan, 734-8551
Hokkaido University Hospital Recruiting
Hokkaido, Japan, 060-8648
Contact: Study Coordinator    +81117067600      
Kanazawa University Hospital Recruiting
Kanazawa-Shi, Japan, 920-8641
Contact: Study Coordinator    +81762652049      
Kobe University Hospital Recruiting
Kobe, Japan, 650-0017
Contact: Study Coordinator    +81783825111      
Cancer Institute Hospital of JFCR Recruiting
Koto-Ku, Japan, 135-8550
Contact: Study Coordinator    +81363164620      
Kyoto University Hospital Recruiting
Kyoto-Shi, Japan, 606-8507
Contact: Study Coordinator    +81757514389      
NHO Shikoku Cancer Center Recruiting
Matsuyama, Japan, 791-0280
Contact: Study Coordinator    +81899991196      
Kyorin University Hospital Recruiting
Mitaka, Japan, 181-8611
Tohoku University Hospital Recruiting
Miyagi, Japan, 980-8574
Hyogo College of Medicine Hospital Recruiting
Nishinomiya, Japan, 663-8501
Osaka International Cancer Institute Recruiting
Osaka-Shi, Japan, 541-8567
Contact: Study Coordinator    +81662026677      
Keio University Hospital Recruiting
Shinanomachi, Japan, 160-8582
Contact: Study Coordinator    +81353633899      
Osaka University Hospital Recruiting
Suita-Shi, Japan, 565-0871
Contact: Study Coordinator    +81367215432      
Jichi Medical University Hospital Recruiting
Tochigi, Japan, 329-0498
Contact: Study Coordinator    +81285587195      
Toyama University Hospital Recruiting
Toyama, Japan, 930-0194
Contact: Study Coordinator    +81776245900      
Yamaguchi University Hospital Recruiting
Ube, Japan, 755-8505
Contact: Study Coordinator    +81825061631      
Wakayama Medical University Hospital Recruiting
Wakayama, Japan, 641-8509
Yokohama City University Medical Center Recruiting
Yokohama, Japan, 232-0024
Contact: Study Coordinator    +81452615656      
Kanagawa Cancer Center Recruiting
Yokohama, Japan, 241-8515
Oita University Hospital Recruiting
Yufu-Shi, Japan, 879-5593
Contact: Study Coordinator    +81975494411      
Kindai University Hospital Recruiting
Ōsaka-sayama City, Japan, 589-8511
Contact: Study Coordinator    +81647063210      
Netherlands
Academic Medical Center Recruiting
Amsterdam, Netherlands, 1105 AZ
Maastricht UMC+ Recruiting
Maastricht, Netherlands, 6202 AZ
Contact: Study Coordinator    +31433871197      
Erasmus UMC Recruiting
Rotterdam, Netherlands, 3015 CE
Contact: Study Coordinator    +31107034897      
UMC Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Study Coordinator    +31887556263      
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0379
Contact: Study Coordinator    +4723027853      
Spain
Hospital de La Santa Creu I Sant Pau Recruiting
Barcelona, Spain, 08026
Contact: Study Coordinator    +34935565585      
Hospital General Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Study Coordinator    +34913368263      
Hospital Clinic De Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Study Coordinator    +34932275400 ext 3303      
Hospital Clinic I Provincial Recruiting
Barcelona, Spain, Barcelona, Spain, 08036
Hospital Universitario Reina Sofia Recruiting
Córdoba, Spain, 14004
Contact: Study Coordinator    +34957011893      
Hospital Materno Teresa Herrera Recruiting
La Coruña, Spain, 15006
Contact: Study Coordinator    +34981178000 ext 292872      
Hospital General Universitario Gregorio Maranon Recruiting
Madrid, Spain, 28007
Contact: Study Coordinator    +34914269629      
Hospital Universitario Ramon Y Cajal Recruiting
Madrid, Spain, 28034
Contact: Study Coordinator    +34913368263      
Hospital Universitario HM Sanchinarro Recruiting
Madrid, Spain, 28050
Contact: Study Coordinator    +34917567800      
Hospital Regional Universitario De Malaga Recruiting
Málaga, Spain, 29010
Contact: Study Coordinator    +34951291425      
Clinica Universidad De Navarra Recruiting
Pamplona, Spain, 31008
Contact: Study Coordinator    +34848428428      
Hospital Universitari Parc Tauli Recruiting
Sabadell, Spain, 08208
Contact: Study Coordinator    +34937240084      
Hospital Universitario Donostia Recruiting
San Sebastián, Spain, 20014
Contact: Study Coordinator    +34943006032      
Hospital General Universitario Marques De Valdecilla Recruiting
Santander, Spain, , 39008
Hospital General Universitario De Valencia Recruiting
Valencia, Spain, 46014
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, 14141
Contact: Study Coordinator    +46851773484      
Switzerland
Inselspital - Universtitaetsspital Bern Recruiting
Bern, Switzerland, 3010
Universtitatsspital Zurich Recruiting
Zurich, Switzerland, 8091
United Kingdom
Aberdenn Royal Infirmary Recruiting
Aberdeen, United Kingdom, AB25 2ZN
Contact: Study Coordinator    +441224555069      
Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Study Coordinator    +441223348076      
Velindre Cancer Centre Recruiting
Cardiff, United Kingdom, CF14 2TL
University Hospital Coventry and Warwickshire Recruiting
Coventry, United Kingdom, CV2 2DEX
The Royal Marsden NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6JJ
Contact: Study Coordinator    +442086426011      
Imperial College Healthcare NHS Trust - Hammersmith Hospital Recruiting
London, United Kingdom, W12 0HS
Contact: Study Coordinator    +442033131000      
University College London Hospitals Recruiting
London, United Kingdom, WC1E 6BT
Maidstone Hospital Recruiting
Maidstone, United Kingdom, ME16 9QQ
Contact: Study Coordinator    +441622225041      
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom, M20 4BV
Contact: Study Coordinator    +441614468106      
The Royal Marsden NHS Foundation Trust Recruiting
Sutton, United Kingdom, SM2 5PT
Contact: Study Coordinator    +442086426011      
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Luis Féliz, MD Incyte Corporation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03656536    
Other Study ID Numbers: INCB 54828-302
First Posted: September 4, 2018    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
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.
URL: https://www.incyte.com/our-company/compliance-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Cholangiocarcinoma
fibroblast growth factor receptor inhibitor
FGFR
FGFR rearrangement
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs