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

• ClinicalTrials.gov Identifier: NCT03656536
• Recruitment Status: Recruiting
• First Posted: September 4, 2018
• Last Update Posted: October 30, 2020
• Sponsor: Incyte Corporation
• Information provided by (Responsible Party): Incyte Corporation

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.

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 Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

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

Sponsors and Collaborators

Incyte Corporation

Investigators

• Study Director: Luis Féliz, MD; Incyte Corporation

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bekaii-Saab TS, Valle JW, Cutsem EV, 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, Féliz 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.

• Responsible Party: Incyte Corporation
• ClinicalTrials.gov Identifier: NCT03656536
• Other Study ID Numbers: INCB 54828-302
• First Posted: September 4, 2018
• 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

Keywords provided by Incyte Corporation:

Cholangiocarcinoma; fibroblast growth factor receptor inhibitor; FGFR; FGFR rearrangement

Additional relevant MeSH terms:

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