A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma - (FIGHT-302)
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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 : October 30, 2020
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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 ...
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 : | June 3, 2019 |
Estimated Primary Completion Date : | October 31, 2023 |
Estimated Study Completion Date : | June 28, 2026 |

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.
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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. |
- 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.
- 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.
- Overall survival [ Time Frame: Up to approximately 12 months ]Defined as the time from date of randomization until death due to any cause.
- 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.
- 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.
- 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.
- Quality of Life impact as assessed by the EQ-5D-3L questionnaire [ Time Frame: Up to 12 months ]
- 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 ]
- Quality of Life impact as assessed by the EORTC QLQ-BIL21 questionnaire [ Time Frame: Up to 12 months ]

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

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
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 |

United States, Arizona | |
Mayo Clinic Hospital | 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 Comprehensive Cancer Center | Completed |
Orange, California, United States, 92868 | |
United States, District of Columbia | |
Georgetown University Hospital | Completed |
Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
Mayo Clinic Jacksonville | 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 | |
University of Chicago Medical Center | Completed |
Chicago, Illinois, United States, 60637 | |
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 | |
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Study Coordinator 410-502-5327 | |
United States, Massachusetts | |
Boston Medical Center | Completed |
Boston, Massachusetts, United States, 02118 | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Study Coordinator 313-576-8496 | |
Henry Ford Health System | 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 | 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 | |
University of Rochester, James P. Wilmot Cancer Center | Not yet recruiting |
Rochester, New York, United States, 14642 | |
White Plains Hospital | Recruiting |
White Plains, 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 | |
Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States, 44195 | |
United States, Oregon | |
Providence Portland Med. Ctr | Recruiting |
Portland, Oregon, United States, 97213 | |
Contact: Study Coordinator 503-215-9570 | |
Oregon Health & 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 | Recruiting |
Greenville, South Carolina, United States, 29605 | |
Contact: Study Coordinator 864-699-5731 | |
United States, Texas | |
Baylor 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-Newport News | Recruiting |
Newport News, Virginia, United States, 23601 | |
Contact: Study Coordinator 757-534-5567 | |
United States, Washington | |
Virginia Mason Med Ctr/Dept of Hematology/Oncology | Recruiting |
Seattle, Washington, United States, 98101 | |
Contact: Study Coordinator 206-287-5671 | |
United States, West Virginia | |
West Virginia University Hospitals Inc | Completed |
Morgantown, West Virginia, United States, 26506 | |
United States, Wisconsin | |
Aurora Health Center | Recruiting |
Wauwatosa, Wisconsin, United States, 53226 | |
Austria | |
Lkh Graz - Universitatsklinik Fur Innere Medizin | Recruiting |
Graz, Austria, 08036 | |
Medical University Innsbruck | Recruiting |
Innsbruck, Austria, A-6020 | |
Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz | Recruiting |
Linz, Austria, 04010 | |
Paracelsus Medical University Salzburg | Recruiting |
Salzburg, Austria, 05020 | |
Landeskrankenhaus Steyr | Recruiting |
Steyr, Austria, 04400 | |
Medizinische Universitat Wien | Recruiting |
Wien, Austria, 01090 | |
Belgium | |
Ulb Hopital Erasme | Recruiting |
Brussels, Belgium, 01070 | |
Universitair Ziekenhuis Gent | Recruiting |
Gent, Belgium, 09000 | |
Az Groeninge - Campus Kennedylaan | Recruiting |
Kortrijk, Belgium, 08500 | |
Hopital de Jolimont | Recruiting |
La Louviere, Belgium, 07100 | |
Universitaire Ziekenhuis Leuven - Gasthuisberg | Recruiting |
Leuven, Belgium, 03000 | |
Chu Ucl Namur, University Hospital Mont-Godinne | Recruiting |
Yvoir, Belgium, 05530 | |
Denmark | |
Herlev Og Gentofte Hospital | Recruiting |
Herlev, Denmark, 02730 | |
Finland | |
Docrates Cancer Center | Recruiting |
Helsinki, Finland, 00180 | |
Contact: Study Coordinator +358505001856 | |
Helsinki University Meilahti Tower Hospital | Recruiting |
Helsinki, Finland, 00290 | |
Contact: Study Coordinator +358505130234 | |
Tampere University Hospital | Recruiting |
Tampere, Finland, 33520 | |
France | |
Institut Sainte Catherine | Recruiting |
Avignon Cedex 9, France, 84918 | |
Centre Hospitalier Universitaire de Besancon | Recruiting |
Besancon, France, 25000 | |
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 Cedex 5, France, 13385 | |
Centre Antoine Lacassagne | Recruiting |
Nice, France, 06189 | |
Hopital Universitaire Pitie-Salpetriere | Recruiting |
Paris, France, 75013 | |
Hopital Europeen Georges Pompidou (Hegp) | Recruiting |
Paris, France, 75015 | |
Hopital Haut Leveque | Recruiting |
Pessac, France, 33604 | |
Centre Hospitalier Universitaire de Poitiers | Recruiting |
Poitiers, France, 86021 | |
Hopital Charles Nicolle Chu Rouen - Hopital de Bois-Guillaume | Recruiting |
Rouen, France, 76031 | |
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau | Recruiting |
Saint Herblain, France, 44800 | |
Chu de Saint-Etienne | Recruiting |
Saint-priest-en-jarez, France, 42270 | |
Chu Toulouse Hopital Rangueil | Recruiting |
Toulouse Cedex 9, France, 31059 | |
Chu Nancy - Hopital Brabois | Recruiting |
Vandoeuvre Les Nancy, France, 54511 | |
Institute Gustave Roussy (Igr) | Recruiting |
Villejuif, France, 94800 | |
Germany | |
University Medical Center Rwth Aachen | Recruiting |
Aachen, Germany, 52074 | |
Charite Universitaetsmedizin Berlin - Campus Charite Mitte | Recruiting |
Berlin, Germany, 10117 | |
Charite - Campus Virchow-Klinikum | Recruiting |
Berlin, Germany, 13353 | |
Universitatsklinikum Bonn Aoer | Recruiting |
Bonn, Germany, 53127 | |
Klinikum Bremen-Nord | Recruiting |
Bremen, Germany, 28755 | |
Technische Universit�T Dresden | Recruiting |
Dresden, Germany, 01307 | |
Klinikum Der Johann Wolfgang Goethe University | Recruiting |
Frankfurt, Germany, 60590 | |
University Medical Center Freiburg | Recruiting |
Freiburg, Germany, 79106 | |
University Medical Centre Hamburg-Eppendorf, Centre of Oncology | Recruiting |
Hamburg, Germany, 20246 | |
Asklepios Klinik Altona | Recruiting |
Hamburg, Germany, 22763 | |
Hannover Medical School | Recruiting |
Hannover, Germany, 30625 | |
University Hospital Saarlandes | Recruiting |
Homburg/saar, Germany, 66424 | |
Universitatsklinikum Koln | Recruiting |
Koln, Germany, 50937 | |
Universitatsklinikum Leipzig Aor | Recruiting |
Leipzig, Germany, 04103 | |
Klinikum Ludwigsburg | Recruiting |
Ludwigsburg, Germany, 71640 | |
Otto-Von-Guericke-Universitat Magdeburg | Recruiting |
Magdeburg, Germany, 39120 | |
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii | Recruiting |
Mainz, Germany, 55131 | |
University Hospital Grosshadern Munich | Recruiting |
Munich, Germany, 81377 | |
Klinikum Nuernberg | Recruiting |
Nuernberg, Germany, 90419 | |
Universitaetsklinikum Tubingen | Recruiting |
Tubingen, Germany, 72076 | |
Universitatsklinikum Ulm | Recruiting |
ULM, Germany, 89081 | |
Ireland | |
St. Vincent'S University Hospital | Recruiting |
Dublin 4, Ireland, D04 Y8V0 | |
Israel | |
Soroka Medical Center | Recruiting |
Beer Sheva, Israel, 84101 | |
Contact: Study Coordinator +97286244068 | |
Rambam Health Care Campus | Recruiting |
Haifa, Israel, 3525408 | |
Hadassah Hebrew University Medical Center Ein Karem Hadassah | Recruiting |
Jerusalem, Israel, 90000 | |
Rabin Medical Center - Beilinson Hospital | Recruiting |
Petach Tikva, Israel, 4841492 | |
Tel Aviv Sourasky Medical Center | Recruiting |
Tel Aviv-yafo, Israel, 64239 | |
Contact: Study Coordinator +97236973021 | |
Italy | |
Azienda Ospedaliero Universitaria Ospedali Riuniti | 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 | |
Na.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 | |
Ieo Istituto Europeo Di Oncologia Irccs | 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 - Policlinico | Recruiting |
Modena, Italy, 41124 | |
Contact: Study Coordinator +393929175678 | |
Istituto Nazionale Tumori Fondazione Irccs G. Pascale | Recruiting |
Naples, Italy, 80131 | |
Universita Degli Studi Della Campania "Luigi Vanvitelli" U.O.C. Oncologia Medica | Recruiting |
Napoli, Italy, 80138 | |
Contact: Study Coordinator +390815666688 | |
Azienda Ospedaliera Universitaria San Luigi Gonzaga (Orbassano) | Recruiting |
Orbassano, Italy, 10043 | |
Iov - Istituto Oncologico Veneto Irccs | Recruiting |
Padova, Italy, 35128 | |
Presidio Ospedaliero Pescara | Recruiting |
Pescara, Italy, 65124 | |
Azienda Ospedaliera Universitaria 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 | |
San Camillo-Forlanini Hospital | Recruiting |
Rome, Italy, 00152 | |
Policlinico Universitario Agostino Gemelli, Universita Cattolica Del Sacro Cuore | 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 | |
Centro Ricerche Cliniche Di Verona (Crc) | Recruiting |
Verona, Italy, 37134 | |
Contact: Study Coordinator +39458126564 | |
San Bartolo Hospital | Recruiting |
Vicenza, Italy, 36100 | |
Contact: Study Coordinator +3904325521 | |
Japan | |
Aichi Cancer Center Hospital | Recruiting |
Aichi, Japan, 464 8681 | |
University of Tokyo Hospital | Recruiting |
Bunkyo, 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, 812-8582 | |
Contact: Study Coordinator +81926411151 | |
National Hospital Organization Kyushu Cancer Center | Recruiting |
Fukuoka, Japan, 811-1395 | |
Contact: Study Coordinator +81925413231 | |
Hiroshima University Hospital | Recruiting |
Hiroshima-shi, Japan, 734-8551 | |
Hokkaido University Hospital | Recruiting |
Hokkaido, Japan, 060-8648 | |
Contact: Study Coordinator +81117067600 | |
Hyogo College of Medicine Hospital | Recruiting |
Hyogo-ken, Japan, 663-8501 | |
Kanazawa University Hospital | Recruiting |
Ishikawa, Japan, 920-8641 | |
Contact: Study Coordinator +81762652049 | |
Teikyo University Hospital | Not yet recruiting |
Itabashi-ku, Japan, 173-8606 | |
Saitama Cancer Center | Recruiting |
Kitaadachi-gun, Japan, 362-0806 | |
Contact: Study Coordinator +81355755862 | |
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 | |
Niigata Cancer Center Hospital | Recruiting |
Niigata, Japan, 951-8566 | |
Osaka International Cancer Institute | Recruiting |
Osaka-shi, Japan, 541-8567 | |
Contact: Study Coordinator +81662026677 | |
Kindai University Hospital | Recruiting |
Osakasayama City, Japan, 589-8511 | |
Contact: Study Coordinator +81647063210 | |
Tohoku University Hospital | Recruiting |
Sendai-shi, Japan, 980-8574 | |
Keio University Hospital | Recruiting |
Shinjuku-ku, Japan, 160-8582 | |
Contact: Study Coordinator +81353633899 | |
Shizuoka Cancer Center | Recruiting |
Shizuoka, Japan, 411-8777 | |
Contact: Study Coordinator +81559895222 | |
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 | |
Kanagawa Cancer Center | Recruiting |
Yokohama-shi, Japan, 241-8515 | |
Yokohama City University Medical Center | Recruiting |
Yokohama, Japan, 232-0024 | |
Contact: Study Coordinator +81452615656 | |
Oita University Hospital | Recruiting |
Yufu-shi, Japan, 879-5593 | |
Contact: Study Coordinator +81975494411 | |
Netherlands | |
Academic Medical Center | Recruiting |
Amsterdam, Netherlands, 1105 AZ | |
Maastricht Umc+ | Recruiting |
Maastricht, Netherlands, 6202 AZ | |
Contact: Study Coordinator +31433871197 | |
Erasmus Mc | 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, 00379 | |
Spain | |
Hospital de La Santa Creu I Sant Pau | Recruiting |
Barcelona, Spain, 08026 | |
Contact: Study Coordinator +34935565585 | |
Hospital General Universitari Vall D Hebron | Recruiting |
Barcelona, Spain, 08035 | |
Contact: Study Coordinator +34913368263 | |
Hospital Clinic I Provincial | Recruiting |
Barcelona, Spain, 08036 | |
Contact: Study Coordinator +34932275400 ext 3303 | |
Hospital Clinic I Provincial | Recruiting |
Barcelona, Spain, 08036 | |
Hospital Universitario Reina Sofia | Recruiting |
Cordoba, Spain, 14004 | |
Hospital Universitario Reina Sofia | Recruiting |
Córdoba, Spain, 14004 | |
Contact: Study Coordinator +34957011893 | |
Hospital Materno Teresa Herrera | Recruiting |
La Coruna, 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 |
Malaga, Spain, 29010 | |
Contact: Study Coordinator +34951291425 | |
Clinica Universidad de Navarra (Cun) | 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 Sebastian, Spain, 20014 | |
Contact: Study Coordinator +34943006032 | |
Hospital Universitario Marques de Valdecilla | Recruiting |
Santander, Spain, 39008 | |
Hospital General Universitario de Valencia | Recruiting |
Valencia, Spain, 46014 | |
Sweden | |
Karolinska University Hospital Huddinge | Recruiting |
Stockholm, Sweden, 14141 | |
Contact: Study Coordinator +46851773484 | |
Switzerland | |
Inselspital - Universitaetsspital Bern | Recruiting |
Bern, Switzerland, 03010 | |
Universtitatsspital Zurich | Recruiting |
Zurich, Switzerland, 08091 | |
United Kingdom | |
Aberdeen 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 | |
Addenbrooke'S Hospital | Recruiting |
Cambridge, United Kingdom, CB2 0QQ | |
Velindre Cancer Centre | Recruiting |
Cardiff, United Kingdom, CF14 2TL | |
University Hospital Coventry and Warwickshire | Recruiting |
Coventry, United Kingdom, CV2 2DX | |
The Royal Marsden Nhs Foundation Trust - Chelsea | 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 | |
Kent Oncology Centre - 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 - Sutton | Recruiting |
Sutton, United Kingdom, SM2 5PT | |
Contact: Study Coordinator +442086426011 |
Study Director: | Luis Féliz, MD | Incyte Corporation |
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: | October 30, 2020 |
Last Verified: | October 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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Cholangiocarcinoma fibroblast growth factor receptor inhibitor FGFR FGFR rearrangement |
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 |