218 Participants NeededMy employer runs this trial

INCA036978 for Myeloproliferative Disorder

Recruiting at 46 trial locations
IC
IC
Overseen ByIncyte Corporation Call Center (ex-US)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)s of INCA036978 administered as monotherapy and in combination with a standard disease-directed therapy.

Who Is on the Research Team?

IM

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

Inclusion Criteria

* Life expectancy \> 6 months.
I am willing to have bone marrow biopsies before and during the study.
I have been diagnosed with MF, PV, or ET.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

INCA036978 is administered at a protocol-defined starting regimen to identify the maximum tolerated dose and/or recommended dose for expansion

Up to 28 days

Dose Expansion

INCA036978 is administered as monotherapy and in combination with a standard disease-directed therapy at the recommended dose for expansion

Up to approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 60 days after last dose

What Are the Treatments Tested in This Trial?

Interventions

  • INCA036978

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Part 2b: Dose ExpansionExperimental Treatment2 Interventions
Group II: Part 2a: Dose ExpansionExperimental Treatment1 Intervention
Group III: Part 1b: Dose EscalationExperimental Treatment2 Interventions
Group IV: Part 1a: Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials
408
Recruited
66,800+
Steven Stein profile image

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot profile image

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School