A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis

PHASE2TerminatedINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

February 8, 2017

Primary Completion Date

January 28, 2021

Study Completion Date

April 29, 2022

Conditions
MPN (Myeloproliferative Neoplasms)
Interventions
DRUG

Parsaclisib

Up to 3 oral once a day (QD) doses of parsaclisib. Doses will be taken once daily for 8 weeks, followed by once weekly dosing at the same dose level.

DRUG

Parsaclisib

Two recommended oral QD doses of parsaclisib. Once daily doses of parsaclisib will be taken for 8 weeks, followed by once weekly dosing at the same dose level.

DRUG

Ruxolitinib

The dose of ruxolitinib will be that which the subjects had been taking for at least 8 weeks before the first dose of parsaclisib.

DRUG

Parsaclisib

20 mg oral QD dose of parsaclisib for 8 weeks. After 8 weeks patients will take either 20 mg once weekly or 5 mg once daily.

DRUG

Parsaclisib

"2 dose strategies will be compared:~1. 5 mg parsaclisib beginning on Day 1 until end of treatment.~2. 20 mg oral QD dose of parsaclisib for 8 weeks; after 8 weeks patients will take 5 mg once daily."

Trial Locations (39)

10029

Mount Sinai School of Medicine, New York

10032

Columbia University Medical Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

10467

Montefiore Medical Center, The Bronx

14263

Roswell Park Cancer Institute, Buffalo

20007

Georgetown University Hospital, Washington D.C.

20817

Cancer Center For Blood Disorders, Bethesda

21229

Saint Agnes Hospital, Baltimore

30322

Emory University, Atlanta

32610

Shands Hospital, Gainesville

35223

Birmingham Hematology & Oncolgy Associates Llc, Birmingham

37203

Rush University Medical Center, Nashville

40202

Norton Cancer Institute, Louisville

44195

Cleveland Clinic, Cleveland

45230

Oncology Hematology Care, Inc., Cincinnati

46237

Indiana Blood and Marrow Transplantation, Indianapolis

50010

McFarland Clinic, Ames

60637

University of Chicago Medical Center, Chicago

63130

Washington University School of Medicine, St Louis

66205

University of Kansas Cancer Center, Westwood

75246

Baylor Scott and White Research Institute, Dallas

77030

Md Anderson Cancer Center, Houston

77380

Renovatio Clinical Consultants Llc, The Woodlands

78217

Cancer Care Centers of South Texas, San Antonio

84112

Va Salt Lake City Health Care System, Salt Lake City

85259

Mayo Clinic Arizona, Scottsdale

87106

New Mexico Cancer Care Alliance, Albuquerque

90033

University of Southern California, Los Angeles

90095

UCLA School of Medicine, Los Angeles

91010

City of Hope National Medical Center, Duarte

92069

California Cancer Assoc. for Research and Excellence, San Marcos

93449

Pcr Oncology, Pismo Beach

93720

California Cancer Associates For Research and Excellence, Fresno

94704

Alta Bates Medical Center, Berkeley

97239

Oregon Health & Science University, Portland

98506

Vista Oncology Inc Ps, Olympia

02114

Massachusetts General Hospital, Boston

07932

Summit Medical Group, Florham Park

07601

Hackensack University Medical Center, Hackensack

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Incyte Corporation

INDUSTRY