Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

137

Participants

Timeline

Start Date

May 18, 2016

Primary Completion Date

February 13, 2019

Study Completion Date

February 13, 2019

Conditions
Solid Tumors
Interventions
DRUG

INCB057643

Initial cohort dose of INCB057643 at the protocol-specified starting dose (Part 1), with subsequent dose escalations based on protocol-specific criteria. The recommended treatment group-specific dose(s) will be taken forward into expansion cohorts (Part 2).

DRUG

Gemcitabine

Standard of Care (SOC) agents

DRUG

Paclitaxel

Standard of Care (SOC) agents

DRUG

Rucaparib

Standard of Care (SOC) agents

DRUG

Abiraterone

Standard of Care (SOC) agents

DRUG

Ruxolitinib

Standard of Care (SOC) agents

DRUG

Azacitidine

Standard of Care (SOC) agents

Trial Locations (18)

14642

University of Rochester, Wilmot Cancer Center, Rochester

27157

Wake Forest Baptist Health, Winston-Salem

27599

University of North Carolina at Chapel Hill, Chapel Hill

33136

Sylvester Comprehensive Cancer Center, Miami

34952

Hematology - Oncology Associates of Treasure Coast, Port Saint Lucie

48109

University of Michigan, Ann Arbor

55455

University of Minnesota, Minneapolis

63110

Washington University, St Louis

75010

HÔPITAL SAINT-LOUIS, Service Hématologie Adultes, Paris

77030

Oncology Consultants, P.A., Houston

The Methodist Hospital, Houston

80218

Sarah Cannon Research Institute at Health One, Denver

84112

Huntsman Cancer Institute, Salt Lake City

92093

University of California, La Jolla

98405

MultiCare Institute for Research and Innovation, Tacoma

35294-3300

University of Alabama, Birmingham

06510

Yale University, New Haven

B-1000

Institut Jules Bordet, Clinical Trial Conduct Unit, Brussels

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Incyte Corporation

INDUSTRY

NCT02711137 - Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies | Biotech Hunter | Biotech Hunter