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

Sponsor
Incyte Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03656536
Collaborator
(none)
434
210
2
104.5
2.1
0

Study Details

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
434 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 :
Jun 3, 2019
Anticipated Primary Completion Date :
Mar 20, 2027
Anticipated Study Completion Date :
Feb 18, 2028

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 Names:
  • 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 [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 [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 [Up to approximately 12 months]

      Defined as the time from date of randomization until death due to any cause.

    3. Duration of response [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 [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 [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 [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 [Up to 12 months]

    8. Quality of Life impact as assessed by the EORTC QLQ-BIL21 questionnaire [Up to 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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).

    • Histologically or cytologically confirmed cholangiocarcinoma that is previously untreated and considered unresectable and/or metastatic (Stage IV per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual).

    • Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1 criteria.

    • Eastern Cooperative Oncology Group performance status 0 to 1.

    • Documented FGFR2 rearrangement.

    • Willingness to avoid pregnancy or fathering children.

    Exclusion Criteria:
    • Received prior anticancer systemic therapy for unresectable and/or metastatic disease (not including adjuvant/neo-adjuvant treatment completed at least 6 months prior to enrollment, and participants that have received treatment for locally advanced disease with trans-arterial chemoembolization or selective internal radiation therapy, if clear evidence of radiological progression is observed before enrollment, or enrolled as of Amendment 6 (or Amendment 5-JP2) and the participant received 1 cycle of gemcitabine plus cisplatin [the start of study drug {Cycle 1 Day 1} must be at least 14 days and ≤ 4 weeks {28 days} from the last dose of gemcitabine plus cisplatin]).

    • Child-Pugh B and C.

    • Toxicities related to prior therapy(ies) must be Common Terminology Criteria for Adverse Events (CTCAE) v5.0 ≤ Grade 1 at the time of screening.

    • Concurrent anticancer therapy, other than the therapies being tested in this study.

    • Participant is a candidate for potentially curative surgery.

    • Current evidence of clinically significant corneal (including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis) or retinal disorder (including but not limited to central serous retinopathy, macular/retinal degeneration, diabetic retinopathy, retinal detachment) as confirmed by ophthalmologic examination.

    • Radiation therapy administered within 4 weeks of enrollment/randomization/first dose of study treatment.

    • Known central nervous system (CNS) metastases or history of uncontrolled seizures.

    • Known additional malignancy that is progressing or requires active treatment (exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy).

    • Laboratory values at screening outside the protocol-defined range.

    • History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues (exception: commonly observed calcifications in soft tissues, such as the skin, kidney, tendons or vessels due to injury, disease, and aging, in the absence of systemic mineral imbalance).

    • Significant gastrointestinal disorders that could interfere with absorption, metabolism, or excretion of pemigatinib.

    • Clinically significant or uncontrolled cardiac disease.

    • History or presence of an abnormal ECG, which, in the investigator's opinion, is clinically meaningful.

    • Chronic or current active infectious disease requiring systemic antibiotics or antifungal or antiviral treatment within 2 weeks prior to enrollment (participants with asymptomatic chronic infections on prophylactic treatment are allowed). Note: HIV-positive participants are allowed if all of the following criteria are met: CD4+ count ≥ 300/µL, undetectable viral load, receiving antiretroviral therapy that does not interact with study drug, and no HIV/AIDS-associated opportunistic infection in the last 12 months.

    • Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment. Note: Moderate CYP3A4 inhibitors are not prohibited

    • Known hypersensitivity or severe reaction to pemigatinib, gemcitabine, cisplatin, or their excipients.

    • Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Arizona Phoenix Arizona United States 85054
    2 Marin Cancer Care Greenbrae California United States 94904
    3 Georgetown University - Lombardi Comprehensive Cancer Center Washington District of Columbia United States 20007
    4 Mayo Clinic - Florida Jacksonville Florida United States 32224
    5 Mount Sinai Medical Center Comprehensive Cancer Center Miami Beach Florida United States 33140
    6 Winship Cancer Institute of Emory University Atlanta Georgia United States 30322
    7 University of Chicago Medical Center Chicago Illinois United States 60637-1447
    8 Parkview Research Center Fort Wayne Indiana United States 46845
    9 University of Iowa Hospital and Clinics Iowa City Iowa United States 52242
    10 The University of Kansas Cancer Center Westwood Kansas United States 66205
    11 Ochsner Clinic Foundation Ocf Ochsner Cancer Institute Oci New Orleans Louisiana United States 70121
    12 Johns Hopkins Oncology Center Baltimore Maryland United States 21287
    13 Boston Medical Center Boston Massachusetts United States 02118
    14 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    15 Barbara Ann Karmanos Cancer Hospital Detroit Michigan United States 48201
    16 Henry Ford Hospital Detroit Michigan United States 48202
    17 Karmanos Cancer Institute Farmington Hills Michigan United States 48334
    18 Mayo Clinic Rochester Minnesota United States 55905
    19 Comprehensive Cancer Centers of Nevada - Twain Las Vegas Nevada United States 89169
    20 Summit Medical Group Florham Park New Jersey United States 07932
    21 Icahn School of Medicine At Mount Sinai New York New York United States 10029
    22 University of Rochester, James P. Wilmot Cancer Center Rochester New York United States 14642
    23 White Plains Hospital White Plains New York United States 10601
    24 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
    25 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    26 Providence Portland Med. Ctr Portland Oregon United States 97213
    27 Oregon Health & Science University Portland Oregon United States 97239
    28 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    29 Greenville Hospital System University Medical Center Institute For Translational Oncology Research Greenville South Carolina United States 29605
    30 Baylor Scott and White Research Institute Dallas Texas United States 75246
    31 Houston Methodist Research Institute Houston Texas United States 77030
    32 Riverside Regional Medical Center Newport News Virginia United States 23601
    33 Virginia Mason Medical Center Seattle Washington United States 98101
    34 West Virginia University Cancer Institute Morgantown West Virginia United States 26506
    35 Aurora Research Institute Wauwatosa Wisconsin United States 53226
    36 Landeskrankenhaus Universitatsklinikum Graz Graz Austria 08036
    37 Innsbruck University Hospital Innsbruck Austria A-6020
    38 Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz Linz Austria 04010
    39 Salzburger Universitatsklinikum Salzburg Austria 05020
    40 Landeskrankenhaus Steyr Steyr Austria 04400
    41 Allgemeines Krankenhaus Der Stadt Wien Vienna Austria 01090
    42 Ulb Hospital Erasme Bruxelles Belgium 01070
    43 Universitair Ziekenhuis Brussel Bruxelles Belgium 01090
    44 Universitair Ziekenhuis Gent Gent Belgium 09000
    45 Hospital de Jolimont Haine-st-paul Belgium 07100
    46 Az Groeninge Campus Kennedylaan Kortrijk Belgium 08500
    47 Universitaire Ziekenhuis Leuven - Gasthuisberg Leuven Belgium 03000
    48 Chu Ucl Namur University Hospital Mont-Godinne Yvoir Belgium 05530
    49 Princess Margaret Cancer Center Toronto Ontario Canada MG5 2M9
    50 Peking Union Medical College Hospital Beijing China 100032
    51 West China Hospital Sichuan University Chengdu China 610041
    52 Fujian Cancer Hospital Fuzhou China 350005
    53 Sun Yat-Sen Memorial Hospital Sun Yat-Sen University Guangdong China 510000
    54 Sun Yat-Sen Memorial Hospital Sun Yat-Sen University Guangzhou China 510000
    55 The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou China 310009
    56 Heilongjiang Province Cancer Hospital Harbin China 150081
    57 University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital) Hefei China 230001
    58 Kunming 1St People'S Hospital Kunming China 650032
    59 Jiangsu Province Hospital Nanjing China 210029
    60 The Affiliated Hospital of Qingdao University Shandong China 266071
    61 Zhongshan Hospital Fudan University Shanghai China 200032
    62 Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai China 200092
    63 Xinhua Hospital SHanghai China 200092
    64 Sichuan Cancer Hospital Sichuan China 610041
    65 Tianjin Medical University Cancer Institute Hospital Tianjin China 300060
    66 Tongji Hospital Huazhong University of Science and Technology Wuhan China 430030
    67 Hubei Cancer Hospital Wuhan China 430079
    68 Northern Jiangsu Peoples Hospital Yangzhou China 225001
    69 Herlev Og Gentofte Hospital Herlev Denmark 02730
    70 Docrates Cancer Center Helsinki Finland 00180
    71 Helsinki University Central Hospital Helsinki Finland 00290
    72 Tampere University Hospital Tampere Finland 33521
    73 Institut Sainte Catherine Avignon Cedex 9 France 84918
    74 Chu Besancon Hospital Jean Minjoz Besancon France 25030
    75 Institut Bergonie Bordeaux Cedex France 33076
    76 Hopital Beaujon Clichy France 92110
    77 Hopital Prive Jean Mermoz Lyon Cedex 08 France 69373
    78 Chu Hopital de La Timone Marseille Cedex 5 France 13385
    79 Centre Hospitalier Universitaire de Nantes Nantes France 44000
    80 Centre Antoine Lacassagne Nice Cedex 02 France 06189
    81 Hospital Universitaire Pitie-Salpetriere Paris Cedex 13 France 75013
    82 Hopital Europeen Georges Pompidou (Hegp) Paris Cedex 15 France 75015
    83 Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque Pessac Cedex France 336600
    84 Hospital de La Miletrie Poitiers Cedex France 86021
    85 Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume Rouen Cedex France 76031
    86 Chu de Saint-Etienne Saint Etienne France 42055
    87 Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau Saint Herblain France 44800
    88 Chu Toulouse Hopital Rangueil Toulouse Cedex 9 France 31059
    89 Chu Vandoeuvre-Les-Nancy Hopital Brabois Vandoeuvre Les Nancy France 54511
    90 Institut Gustave Roussy Villejuif Cedex France 94805
    91 University Medical Center Rwth Aachen Aachen Germany 52074
    92 Charite - Campus Virchow-Klinikum Berlin Germany 13353
    93 Charite Universitaetsmedizin Berlin - Campus Charite Mitte Berlin Germany 13353
    94 Universitatsklinikum Bonn Aoer Bonn Germany 53127
    95 Klinikum Bremen-Nord Bremen Germany 28755
    96 University Clinic Carl Gustav Carus Technical University Dresden Dresden Germany 01307
    97 Klinikum Der Johann Wolfgang Goethe University Frankfurt Germany 60590
    98 University Medical Center Freiburg Freiburg Germany 79106
    99 Universitatsklinikum Hamburg Eppendorf Hamburg Germany 20246
    100 Asklepios Klinik Altona Hamburg Germany 22763
    101 Hannover Medical School Hannover Germany 30625
    102 Universitaetsklinikum Des Saarlandes Homburg / Saar Germany 66421
    103 Universitatsklinikum Koln Koln Germany 50937
    104 Universitatsklinikum Leipzig Aor Leipzig Germany 04103
    105 Klinikum Ludwigsburg Ludwigsburg Germany 71640
    106 OTTO-VON-GUERICKE-UNIVERSIT�T MAGDEBURG Magdeburg Germany 39120
    107 Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii Mainz Germany 55131
    108 University Hospital Grosshadern Munich Munich Germany 81377
    109 Klinikum Nuernberg Nuernberg Germany 90419
    110 Universitaetsklinikum in Tubingen Tubingen Germany 72076
    111 University Hospital Tuebingen Tubingen Germany 72076
    112 UNIVERSIT�TSKLINIKUM ULM ULM Germany 89081
    113 St. Vincent'S University Hospital Dublin 4 Ireland D04 Y8V0
    114 Soroka University Medical Center Beer-sheva Israel 84001
    115 Rambam Health Care Campus Haifa Israel 3109601
    116 Hadassah University Hospital Jerusalem Israel 9112001
    117 Rabin Medical Center - Beilinson Hospital Petach Tikva Israel 4941492
    118 Tel Aviv Sourasky Medical Center Tel Aviv Israel 64239
    119 Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona Italy 60126
    120 Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari Bari Italy 70124
    121 Ospedale Papa Giovanni Xxiii Bergamo Italy 24127
    122 L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI Bologna Italy 40138
    123 Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo Candiolo Italy 10060
    124 Presidio Ospedaliero Garibaldi Nesima Catania Italy 95100
    125 Ospedale Degli Infermi - Faenza Faenza Italy 48018
    126 Irccs Azienda Ospedaliera Universitaria San Martino Genova Italy 16132
    127 Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele Milan Italy 20132
    128 Fondazione Irccs Istituto Nazionale Dei Tumori Milan Italy 20133
    129 European Institute of Oncology Milan Italy 20141
    130 Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Milan Italy 20162
    131 A.O.U. Di Modena - Policlinico Modena Italy 41124
    132 Istituto Nazionale Tumori Irccs Fondazione Pascale Napoli Italy 80131
    133 Universita Degli Studi Della Campania Luigi Vanvitelli U.O.C. Oncologia Medica Napoli Italy 80138
    134 Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano Orbassano Italy 10043
    135 Iov - Istituto Oncologico Veneto Irccs Padova Italy 35128
    136 Presidio Ospedaliero Pescara Pescara Italy 65124
    137 Azienda Ospedaliera Universitaria Pisana Pisa Italy 56126
    138 Istituto Nazionale Tumori Regina Elena Irccs Roma Italy 00144
    139 Fondazione Policlinico Universitario Agostino Gemelli Irccs Roma Italy 00168
    140 Universita Campus Bio Medico Di Roma Rome Italy 00128
    141 Azienda Ospedaliera San Camillo Forlanini Rome Italy 00152
    142 Irccs Istituto Clinico Humanitas Rozzano Italy 20089
    143 Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte Siena Italy 53100
    144 Centro Ricerche Cliniche Di Verona (Crc) Verona Italy 37134
    145 San Bartolo Hospital Vicenza Italy 36100
    146 Aichi Cancer Center Hospital Aichi Japan 464 8681
    147 University of Tokyo Hospital Bunkyo Japan 113-8655
    148 Chiba University Hospital Chiba Japan 260-8677
    149 Chiba Cancer Center Chiba Japan 260-8717
    150 National Hospital Organization Kyushu Cancer Center Fukuoka-shi Japan 812-8582
    151 National Hospital Organization Kyushu Cancer Center Fukuoka Japan 811-1395
    152 Hiroshima University Hospital Hiroshima-shi Japan 734-8551
    153 Hokkaido University Hospital Hokkaido Japan 060-8648
    154 Hyogo College of Medicine Hospital Hyogo Japan 663-8501
    155 Kanazawa University Hospital Ishikawa Japan 920-8641
    156 Teikyo University Hospital Itabashi-ku Japan 173-8606
    157 Kobe University Hospital Kobe Japan 650-0017
    158 Cancer Institute Hospital of Jfcr Koto-ku Japan 135-8550
    159 Kyoto University Hospital Kyoto-shi Japan 606-8507
    160 Nho Shikoku Cancer Center Matsuyama Japan 791-0280
    161 Kyorin University Hospital Mitaka Japan 181-8611
    162 Niigata Cancer Center Hospital Niigata Japan 951-8566
    163 Osaka International Cancer Institute Osaka-shi Japan 541-8567
    164 Kindai University Hospital Osakasayama City Japan 589-8511
    165 Saitama Cancer Center Saitama Japan 362-0806
    166 Tohoku University Hospital Sendai-shi Japan 980-8574
    167 Keio University Hospital Shinjuku-ku Japan 160-8582
    168 Shizuoka Cancer Center Shizuoka Japan 411-8777
    169 Osaka University Hospital Suita-shi Japan 565-0871
    170 Jichi Medical University Hospital Tochigi Japan 329-0498
    171 Toyama University Hospital Toyama Japan 930-0194
    172 Yamaguchi University Hospital UBE Japan 755-8505
    173 Wakayama Medical University Hospital Wakayama Japan 641-8509
    174 Kanagawa Cancer Center Yokohama-shi Japan 241-8515
    175 Yokohama City University Medical Center Yokohama Japan 232-0024
    176 Oita University Hospital Yufu-shi Japan 879-5593
    177 Amsterdam University Medical Centre Amsterdam Netherlands 1100 DD
    178 Maastricht Umc+ Maastricht Netherlands 6202 AZ
    179 Erasmus Medical Center Rotterdam Netherlands 3015 CE
    180 Umc Utrecht Utrecht Netherlands 3584 CX
    181 Oslo University Hospital Oslo Norway 00450
    182 Hospital de La Santa Creu I Sant Pau Barcelona Spain 08026
    183 Hospital General Universitario Vall D Hebron Barcelona Spain 08035
    184 Hospital Clinic I Provincial Barcelona Spain 08036
    185 Hospital Clinic de Barcelona Barcelona Spain 8036
    186 Hospital Universitario Reina Sofia Cordoba Spain 14004
    187 Hospital Universitario Reina Sofia Córdoba Spain 14004
    188 Hospital Materno Teresa Herrera La Coruna Spain 15006
    189 Hospital General Universitario Gregorio Maranon Madrid Spain 28007
    190 Hospital Universitario Ramon Y Cajal Madrid Spain 28034
    191 Hospital Universitario Hm Sanchinarro Madrid Spain 28050
    192 Hospital Regional Universitario de Malaga Malaga Spain 29010
    193 Clinica Universidad de Navarra (Cun) Pamplona Spain 31008
    194 Hospital Universitari Parc Tauli Sabadell Spain 08208
    195 HOSPITAL UNiVERSITARIO DONOSTIA San Sebastian Spain 20014
    196 Hospital Universitario Marques de Valdecilla Santander Spain 39008
    197 Hospital General Universitario de Valencia Valencia Spain 46014
    198 Karolinska Institute Universitetssjukhuset Solna Solna Sweden 171 64
    199 Inselspital - Universitaetsspital Bern Bern Switzerland 03010
    200 Universitatsspital Zurich Zuerich Switzerland 08091
    201 Aberdeen Royal Infirmary Aberdeen United Kingdom AB25 2ZN
    202 Addenbrooke'S Hospital Cambridge United Kingdom CB2 0QQ
    203 Velindre Cancer Centre Cardiff United Kingdom CF14 2TL
    204 University Hospital Coventry and Warwickshire Coventry United Kingdom CV2 2DX
    205 The Royal Marsden Nhs Foundation Trust - Chelsea London United Kingdom SW3 6JJ
    206 Imperial College Healthcare Nhs Trust - Hammersmith Hospital London United Kingdom W12 0HS
    207 University College London Hospitals (Uclh) London United Kingdom WC1E 6BT
    208 Kent Oncology Centre - Maidstone Hospital Maidstone United Kingdom ME16 9QQ
    209 The Christie Nhs Foundation Trust Manchester United Kingdom M20 4BV
    210 The Royal Marsden Nhs Foundation Trust - Sutton Sutton United Kingdom SM2 5PT

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: Peter Langmuir, MD, Incyte Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT03656536
    Other Study ID Numbers:
    • INCB 54828-302
    First Posted:
    Sep 4, 2018
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Incyte Corporation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 27, 2022