← Back to Search

JAK Inhibitor

INCB160058 for Myeloproliferative Disorder

Phase 1
Recruiting
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previously treated with at least 1 JAK inhibitor for ≥ 12 weeks and resistant, refractory, intolerant to, or have lost response to JAK inhibitor treatment
Existing documentation of JAK2V617F mutation from a qualified local laboratory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12 and 24 and then every 24 weeks up to 2 years
Awards & highlights

Summary

This trial is testing a new drug called INCB160058 to see if it is safe and well-tolerated in people with a type of blood disorder called Myeloproliferative Neop

Who is the study for?
This trial is for adults over 18 with Myeloproliferative Neoplasms who've lived more than 6 months after diagnosis. They should have symptoms or an enlarged spleen and be at intermediate-1 risk or higher. Participants must have tried a JAK inhibitor treatment for at least 12 weeks without success, and be willing to undergo bone marrow tests.
What is being tested?
The study is testing the safety, how well people can handle, and how the body processes INCB160058 in those with Myeloproliferative Neoplasms. It's specifically for patients who haven't responded well to previous treatments.
What are the potential side effects?
Potential side effects of INCB160058 are not detailed here but generally could include issues related to blood counts, gastrointestinal symptoms, liver enzyme changes, fatigue, or other drug-specific reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been treated with a JAK inhibitor for 12 weeks or more and it didn't work for me.
Select...
My tests show a JAK2V617F mutation.
Select...
My condition is a type of bone marrow cancer that is at an intermediate-1 or higher risk level.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12 and 24 and then every 24 weeks up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 and 24 and then every 24 weeks up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with Dose Limiting Toxicities (DLTs)
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Secondary study objectives
INCB160058 pharmacokinetic (PK) in Plasma
Participants with MF with symptomatic anemia: Anemia Response
Percentage of participants achieving spleen volume reduction as defined in the protocol
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2 Dose Expansion - with MFExperimental Treatment1 Intervention
INCB160058 will be administered at the RDE(s) identified during Part 1. Participants with MF will enroll in this group.
Group II: Part 1 Dose Escalation - with MFExperimental Treatment1 Intervention
INCB160058 will be administered at a protocol defined starting regimen to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with myelofibrosis (MF) will enroll in this group.

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
382 Previous Clinical Trials
56,986 Total Patients Enrolled
Incyte MedicalStudy DirectorIncyte Corporation
2 Previous Clinical Trials
89 Total Patients Enrolled
~44 spots leftby Jun 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top