Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

February 23, 2021

Primary Completion Date

December 30, 2025

Study Completion Date

December 30, 2026

Conditions
MyelofibrosisMyelodysplastic SyndromeMyelodysplastic/Myeloproliferative Neoplasm Overlap SyndromeMyeloproliferative NeoplasmRelapsed or Refractory Primary MyelofibrosisSecondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis)ET (Essential Thrombocythemia)
Interventions
DRUG

INCB057643

INCB057643 dose escalation and dose expansion.

DRUG

Ruxolitinib

Ruxolitinib will be administered twice a day using the dose described for each Cohort in the protocol for Part 2.

Trial Locations (48)

10016

Nyu Langone Laura and Isaac Perlmutter Cancer Center, New York

10021

Weill Medical College of Cornell University, New York

10043

Azienda Ospedaliero Universitaria San Luigi Gonzaga Di Orbassano, Orbassano

11501

Nyu Langone Health - Long Island Hospital, Mineola

20122

Fondazione Irccs Ca Granda Ospedale Maggiore, Milan

27514

University of North Carolina At Chapel Hill, Chapel Hill

28041

Hospital Universitario 12 de Octubre, Madrid

30120

Hospital Universitario Virgen de La Arrixaca, Murcia

30322

Emory University-Winship Cancer Institute, Atlanta

33136

University of Miami Sylvester Comprehensive Cancer Center, Miami

35010

Hospital Universitario de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria

35294

University of Alabama At Birmingham, Birmingham

37007

Hospital Clinico Universitario de Salamanca, Salamanca

37134

Centro Ricerche Cliniche Di Verona, Verona

40138

Aou Policlinico S. Orsola-Malpighi, Bologna

43210

Ohio State University, Columbus

45267

University of Cincinnati Cancer Institute, Cincinnati

47014

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori, Meldola

50134

Azienda Ospedaliero-Universitaria Careggi (Aouc), Florence

52242

University of Iowa Hospital and Clinics, Iowa City

63110

Washington University School of Medicine, St Louis

75246

Texas Oncology-Baylor Sammons Cancer Center, Dallas

77030

Md Anderson Cancer Center, Houston

Oncology Consultants, Houston

80045

University of Colorado Cancer Center, Aurora

84112

Huntsman Cancer Institute At University of Utah, Salt Lake City

97239

Oregon Health and Science University, Portland

98109

Fred Hutchinson Cancer Center, Seattle

100730

Peking Union Medical College Hospital, Beijing

310003

The First Affiliated Hospital, Zhejiang University School of Medicine (Fahzu), Hangzhou

450003

Henan Cancer Hostipal, Zhengzhou

510515

Nanfang Hospital_Southern Medical University, Guangzhou

08901

Rutgers Cancer Institute of Nj, New Brunswick

M5G 2M9

Princess Margaret Cancer Center, Toronto

H3T 1E2

McGill University Jewish General Hospital, Montreal

V6Z2A5

St Paul'S Hospital, Vancouver

00029

Helsinki University Central Hospital, Helsinki

470-1192

Fujita Health University Hospital, Aichi

260-8677

Chiba University Hospital, Chiba

277-8577

National Cancer Center Hospital East, Chiba

409-3898

University of Yamanashi Hospital, Chūō

Unknown

Kyushu University Hospital, Fukuoka

862-8655

Kumamoto Shinto General Hospital, Kumamoto

08916

Hospital Universitari Germans Trias I Pujol, Badalona

PE21 9QS

United Lincolnshire Hospitals, Boston

LN2 5QY

Lincoln County Hospital, Lincoln

M20 4BX

The Christie Nhs Foundation Trust Uk, Manchester

OX3 7LE

University of Oxford, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Incyte Corporation

INDUSTRY

NCT04279847 - Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms | Biotech Hunter | Biotech Hunter