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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

No Placebo-Only Group

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

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I have been treated with a JAK inhibitor for 12 weeks or more and it didn't work for me.

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My tests show a JAK2V617F mutation.

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My condition is a type of bone marrow cancer that is at an intermediate-1 or higher risk level.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12 and 24 and then every 24 weeks up to 2 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met