Study Stopped
The study was terminated due to lack of enrollment resulting from a change in the standard of care for the first-line treatment of patients with cholangiocarcinoma. There were no safety concerns that contributed to this decision.
A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma
FIGHT-302
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)
3 other identifiers
interventional
167
19 countries
215
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2019
Longer than P75 for phase_3
215 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2018
CompletedFirst Posted
Study publicly available on registry
September 4, 2018
CompletedStudy Start
First participant enrolled
June 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2025
CompletedAugust 24, 2025
August 1, 2025
6.1 years
August 29, 2018
August 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to approximately 12 months
Secondary Outcomes (8)
Overall response rate
Up to approximately 12 months
Overall survival
Up to approximately 12 months
Duration of response
Up to approximately 12 months
Disease control rate
Up to approximately 12 months
Number of treatment-emergent adverse events
Up to approximately 12 months
- +3 more secondary outcomes
Study Arms (2)
Pemigatinib
EXPERIMENTALGemcitabine + Cisplatin
ACTIVE COMPARATORParticipants 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.
Interventions
Pemigatinib at the protocol-defined dose administered orally once daily as continuous therapy schedule (a cycle is 3 weeks).
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (215)
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
Marin Cancer Care
Greenbrae, California, 94904, United States
UC Irvine Medical Center
Orange, California, 92868-3201, United States
Georgetown University-Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007, United States
Mayo Clinic-Florida
Jacksonville, Florida, 32224, United States
Mount Sinai Medical Center Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
University of Chicago Medical Center
Chicago, Illinois, 60637-1447, United States
Parkview Research Center
Fort Wayne, Indiana, 46845, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242, United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Ochsner Clinic Foundation Ocf Ochsner Cancer Institute Oci
New Orleans, Louisiana, 70121, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21287, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Barbara Ann Karmanos Cancer Hospital
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Karmanos Cancer Institute
Farmington Hills, Michigan, 48334, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Comprehensive Cancer Centers of Nevada-Twain
Las Vegas, Nevada, 89169, United States
Summit Medical Group
Florham Park, New Jersey, 07932, United States
Icahn School of Medicine At Mount Sinai
New York, New York, 10029, United States
White Plains Hospital
White Plains, New York, 10601, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Providence Portland Med. Ctr
Portland, Oregon, 97213, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Greenville Hospital System University Medical Center Institute For Translational Oncology Research
Greenville, South Carolina, 29605, United States
Baylor Scott and White Research Institute
Dallas, Texas, 75246, United States
Houston Methodist Research Institute
Houston, Texas, 77030, United States
Riverside Regional Medical Center
Newport News, Virginia, 23601, United States
Virginia Commonwealth University
Richmond, Virginia, 23229, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
West Virginia University Cancer Institute
Morgantown, West Virginia, 26506, United States
Aurora Research Institute
Wauwatosa, Wisconsin, 53226, United States
Landeskrankenhaus Universitatsklinikum Graz
Graz, 08036, Austria
Innsbruck University Hospital
Innsbruck, A-6020, Austria
Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz
Linz, 04010, Austria
Salzburger Universitatsklinikum
Salzburg, 05020, Austria
Landeskrankenhaus Steyr
Steyr, 04400, Austria
Allgemeines Krankenhaus Der Stadt Wien
Vienna, 01090, Austria
Ulb Hospital Erasme
Brussels, 01070, Belgium
Universitair Ziekenhuis Brussel
Brussels, 01090, Belgium
Universitair Ziekenhuis Gent
Ghent, 09000, Belgium
Hospital de Jolimont
Haine-st-paul, 07100, Belgium
Az Groeninge Campus Kennedylaan
Kortrijk, 08500, Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven, 03000, Belgium
Chu Ucl Namur University Hospital Mont-Godinne
Yvoir, 05530, Belgium
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cancercare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Nova Scotia Health Authority/Qeii Health Sciences Centre
Halifax, Nova Scotia, B3H 4K4, Canada
Princess Margaret Cancer Center
Toronto, Ontario, MG5 2M9, Canada
McGill University Health Centre Research Institute
Montreal, Quebec, H4A 3J1, Canada
Peking Union Medical College Hospital
Beijing, 100032, China
West China Hospital Sichuan University
Chengdu, 610041, China
Fujian Cancer Hospital
Fuzhou, 350005, China
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
Guangdong, 510000, China
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
Guangzhou, 510000, China
Shulan Hangzhou Hospital Co Ltd
Hangzhou, 310000, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, 310009, China
Heilongjiang Province Cancer Hospital
Harbin, 150081, China
University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)
Hefei, 230001, China
Kunming 1St People'S Hospital
Kunming, 650032, China
Jiangsu Province Hospital
Nanjing, 210029, China
The Affiliated Hospital of Qingdao University
Shandong, 266071, China
Zhongshan Hospital Fudan University
Shanghai, 200032, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092, China
Xinhua Hospital
Shanghai, 200092, China
Sichuan Cancer Hospital
Sichuan, 610041, China
Tianjin Medical University Cancer Institute Hospital
Tianjin, 300060, China
Tongji Hospital Huazhong University of Science and Technology
Wuhan, 430030, China
Hubei Cancer Hospital
Wuhan, 430079, China
Northern Jiangsu Peoples Hospital
Yangzhou, 225001, China
Herlev Og Gentofte Hospital
Herlev, 02730, Denmark
Docrates Cancer Center
Helsinki, 00180, Finland
Helsinki University Central Hospital
Helsinki, 00290, Finland
Tampere University Hospital
Tampere, 33521, Finland
Institut Sainte Catherine
Avignon, 84918, France
Chu Besancon Hospital Jean Minjoz
Besançon, 25030, France
Institut Bergonie
Bordeaux, 33076, France
Hopital Beaujon
Clichy, 92110, France
Chu de Limoges - Hospital Dupuytren
Limoges, 87042, France
Hopital Prive Jean Mermoz
Lyon, 69373, France
Chu Hopital de La Timone
Marseille, 13385, France
Centre Hospitalier Universitaire de Nantes
Nantes, 44000, France
Centre Antoine Laccassagne
Nice, 06189, France
Hospital Universitaire Pitie-Salpetriere
Paris, 75013, France
Hopital Europeen Georges Pompidou (Hegp)
Paris, 75015, France
Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque
Pessac, 336600, France
Hospital de La Miletrie
Poitiers, 86021, France
Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
Rouen, 76031, France
University Hospital of Saint Etienne
Saint-Etienne, 42055, France
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
Saint-Herblain, 44800, France
Chu Toulouse Hopital Rangueil
Toulouse, 31059, France
Chu Vandoeuvre-Les-Nancy Hopital Brabois
Vandœuvre-lès-Nancy, 54511, France
Institut Gustave Roussy
Villejuif, 94805, France
University Medical Center Rwth Aachen
Aachen, 52074, Germany
Charite - Campus Virchow-Klinikum
Berlin, 13353, Germany
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, 13353, Germany
Universitatsklinikum Bonn Aoer
Bonn, 53127, Germany
Klinikum Bremen-Nord
Bremen, 28755, Germany
Universitatsklinikum Koln
Cologne, 50937, Germany
University Clinic Carl Gustav Carus Technical University Dresden
Dresden, 01307, Germany
Klinikum Der Johann Wolfgang Goethe University
Frankfurt am Main, 60590, Germany
University Medical Center Freiburg
Freiburg im Breisgau, 79106, Germany
Universitatsklinikum Hamburg Eppendorf
Hamburg, 20246, Germany
Asklepios Klinik Altona
Hamburg, 22763, Germany
Hannover Medical School
Hanover, 30625, Germany
Universitaetsklinikum Des Saarlandes
Homburg / SAAR, 66421, Germany
Universitatsklinikum Leipzig Aor
Leipzig, 04103, Germany
Klinikum Ludwigsburg
Ludwigsburg, 71640, Germany
Otto-Von-Guericke-Universitat Magdeburg
Magdeburg, 39120, Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, 55131, Germany
University Hospital Grosshadern Munich
Munich, 81377, Germany
Klinikum Nuernberg
Nuremberg, 90419, Germany
Universitaetsklinikum in Tubingen
Tübingen, 72076, Germany
University Hospital Tuebingen
Tübingen, 72076, Germany
Universitatkinikums Ulm
Ulm, 89081, Germany
St. Vincent'S University Hospital
Dublin, D04 Y8V0, Ireland
Soroka University Medical Center
Beersheba, 84001, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Hadassah University Hospital
Jerusalem, 9112001, Israel
Rabin Medical Center - Beilinson Hospital
Petah Tikva, 4941492, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Azienda Ospedaliero Universitaria Delle Marche
Ancona, 60126, Italy
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
Bari, 70124, Italy
Ospedale Papa Giovanni Xxiii
Bergamo, 24127, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, 40138, Italy
Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo
Candiolo, 10060, Italy
Presidio Ospedaliero Garibaldi Nesima
Catania, 95100, Italy
Ospedale Degli Infermi - Faenza
Faenza, 48018, Italy
Irccs Azienda Ospedaliera Universitaria San Martino
Genova, 16132, Italy
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
Milan, 20132, Italy
European Institute of Oncology
Milan, 20141, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
Milan, 20133, Italy
A.O.U. Di Modena - Policlinico
Modena, 41124, Italy
Istituto Nazionale Tumori Irccs Fondazione Pascale
Napoli, 80131, Italy
Universita Degli Studi Della Campania Luigi Vanvitelli U.O.C. Oncologia Medica
Napoli, 80138, Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano
Orbassano, 10043, Italy
Iov - Istituto Oncologico Veneto Irccs
Padua, 35128, Italy
Presidio Ospedaliero Pescara
Pescara, 65124, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126, Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Roma, 00137, Italy
Istituto Nazionale Tumori Regina Elena Irccs
Roma, 00144, Italy
Universita Campus Bio Medico Di Roma
Rome, 00128, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, 00152, Italy
Irccs Istituto Clinico Humanitas
Rozzano, 20089, Italy
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
Siena, 53100, Italy
Centro Ricerche Cliniche Di Verona (Crc)
Verona, 37134, Italy
San Bartolo Hospital
Vicenza, 36100, Italy
University of Tokyo Hospital
Bunkyō City, 113-8655, Japan
Chiba University Hospital
Chiba, 260-8677, Japan
Chiba Cancer Center
Chiba, 260-8717, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
Hyogo College of Medicine Hospital
Hyōgo, 663-8501, Japan
Kanazawa University Hospital
Ishikawa, 920-8641, Japan
Teikyo University Hospital
Itabashi-ku, 173-8606, Japan
Kobe University Hospital
Kobe, 650-0017, Japan
Cancer Institute Hospital of Jfcr
Kōtoku, 135-8550, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Nho Shikoku Cancer Center
Matsuyama, 791-0280, Japan
Kyorin University Hospital
Mitaka-shi, 181-8611, Japan
Aichi Cancer Center Hospital
Nagoya, 464-8681, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Saitama Cancer Center
Saitama, 362-0806, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Kindai University Hospital
Sayama, 589-8511, Japan
Tohoku University Hospital
Sendai, 980-8574, Japan
Jichi Medical University Hospital
Shimotsuke-shi, 329-0498, Japan
Keio University Hospital
Shinjuku-ku, 160-8582, Japan
Shizuoka Cancer Center
Shizuoka, 411-8777, Japan
Osaka University Hospital
Suita-shi, 565-0871, Japan
Toyama University Hospital
Toyama, 930-0194, Japan
Yamaguchi University Hospital
Ube, 755-8505, Japan
Wakayama Medical University Hospital
Wakayama, 641-8509, Japan
Yokohama City University Medical Center
Yokohama, 232-0024, Japan
Kanagawa Cancer Center
Yokohama, 241-8515, Japan
Oita University Hospital
Yufu-shi, 879-5593, Japan
Amsterdam University Medical Centre
Amsterdam, 1100 DD, Netherlands
Maastricht Umc+
Maastricht, 6202 AZ, Netherlands
Erasmus Medical Center
Rotterdam, 3015 CE, Netherlands
Umc Utrecht
Utrecht, 3584 CX, Netherlands
Oslo University Hospital
Oslo, 00450, Norway
Hospital Materno Teresa Herrera
A Coruña, 15006, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, 08026, Spain
Hospital General Universitario Vall D Hebron
Barcelona, 08035, Spain
Hospital Clinic Barcelona Main
Barcelona, 08036, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
HOSPITAL UNiVERSITARIO DONOSTIA
Donostia / San Sebastian, 20014, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Hospital Universitario Hm Sanchinarro
Madrid, 28050, Spain
Hospital Regional Universitario de Malaga
Málaga, 29010, Spain
Clinica Universidad de Navarra (Cun)
Pamplona, 31008, Spain
Hospital Universitari Parc Tauli
Sabadell, 08208, Spain
Hospital Universitario Marques de Valdecilla
Santander, 39008, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
Karolinska Institute Universitetssjukhuset Solna
Solna, 171 64, Sweden
Inselspital - Universitaetsspital Bern
Bern, 03010, Switzerland
Universitatsspital Zurich
Zurich, 08091, Switzerland
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN, United Kingdom
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
Velindre Cancer Centre
Cardiff, CF14 2TL, United Kingdom
University Hospital Coventry and Warwickshire
Coventry, CV2 2DX, United Kingdom
The Royal Marsden Nhs Foundation Trust - Chelsea
London, SW3 6JJ, United Kingdom
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London, W12 0HS, United Kingdom
University College London Hospitals (Uclh)
London, WC1E 6BT, United Kingdom
Kent Oncology Centre - Maidstone Hospital
Maidstone, ME16 9QQ, United Kingdom
The Christie Nhs Foundation Trust
Manchester, M20 4BV, United Kingdom
The Royal Marsden Nhs Foundation Trust - Sutton
Sutton, SM2 5PT, United Kingdom
Related Publications (1)
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.
PMID: 32677452DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peter Langmuir, MD
Incyte Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
August 29, 2018
First Posted
September 4, 2018
Study Start
June 3, 2019
Primary Completion
July 7, 2025
Study Completion
July 7, 2025
Last Updated
August 24, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, 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.
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