INCB160058 for Myeloproliferative Disorder

Recruiting at 11 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Incyte Corporation

Must be taking: JAK inhibitors

Must not be taking: G-CSF, GM-CSF

Disqualifiers: Hematological malignancy, Major bleeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

144 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.

Do I need to stop my current medications to join the trial?

The trial requires that you stop any prior MF-directed therapy at least 28 days before starting the study treatment. Additionally, you must not be on certain treatments like G-CSF, GM-CSF, romiplostim, or eltrombopag within 4 weeks before the first dose.

Research Team

Incyte Medical

Principal Investigator

Incyte Corporation

Eligibility Criteria

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.

Inclusion Criteria

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

My tests show a JAK2V617F mutation.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

INCB160058 is administered to identify the maximum tolerated dose and/or recommended dose for expansion in participants with myelofibrosis

4 weeks

Dose Expansion

INCB160058 is administered at the recommended dose identified during dose escalation to participants with myelofibrosis

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years and 30 days

Treatment Details

Interventions

• INCB160058

Trial Overview 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.

Participant Groups

Group I: Part 2 Dose Expansion - with MF, PV or ET Experimental Treatment 1 Intervention

INCB160058 will be administered at the RDE(s) identified during Part 1. Participants with MF, PV or ET will enroll in this group.

Group II: Part 1 Dose Escalation - with MF, PV or ET Experimental Treatment 1 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), polycythemia vera (PV) or essential thrombocythemia (ET) will enroll in this group.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School