A Phase 1, Open-Label, Multicenter Study of INCB160058 in Participants With Myeloproliferative Neoplasms INCB160058

What's the purpose of this trial?

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

This trial is currently open and accepting patients.


What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

* Age ≥ 18 years
* MF: Intermediate-1 or higher risk PMF, post-PV MF, or post-ET MF with evidence of minimum burden of disease based on splenomegaly and previously treated with at least 1 JAK inhibitor for ≥ 12 weeks and resistant, refractory, intolerant to, or have lost response to JAK inhibitor treatment.
* PV: Confirmed diagnosis of PV and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment.
* ET: Confirmed diagnosis of high-risk ET as defined in the protocol and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment.
* Life expectancy \> 6 months.
* Willingness to undergo a pretreatment and regular on-study bone marrow biopsies and aspirations (as appropriate to disease).
* Existing documentation of JAK2V617F mutation from a qualified local laboratory.

Exclusion Criteria:

* Presence of a hematological malignancy requiring treatment, other than PMF, post-PV MF, post-ET MF, PV, or ET.
* Prior history of major bleeding or thrombosis within the 3 months prior to study enrollment.
* Participants with abnormal hematologic, hepatic, or renal function based on laboratory evaluation.
* Has undergone prior allogenic or autologous stem-cell transplantation or allogenic stem-cell transplantation is planned
* Active invasive malignancy.
* Significant concurrent, uncontrolled medical condition.
* Acute or chronic HBV, active HCV or known HIV.
* Any prior MPN-directed therapy within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
* Participants undergoing treatment with G-CSF or GM-CSF, romiplostim, or eltrombopag at any time within 4 weeks before the first dose of study treatment.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Additional Trial Information

Phase 1

Enrollment: 144 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

Stanford University Cancer Institute (Palo Alto)

Stanford, CA

Open and Accepting

Florida

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Not Yet Accepting

Indiana

Simon Cancer Center Indiana University

Indianapolis, IN

Open and Accepting

Kansas

University of Kansas Cancer Center (Westwood)

Westwood, KS

Open and Accepting

Michigan

University of Michigan Comprehensive Cancer Center Rogel Cancer Center

Ann Arbor, MI

Not Yet Accepting

New Jersey

Memorial Sloan Kettering Basking Ridge

Basking Ridge, NJ

Open and Accepting

Memorial Sloan Kettering Monmouth

Middletown, NJ

Open and Accepting

Memorial Sloan Kettering Bergen

Montvale, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Memorial Sloan Kettering Commack

Commack, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

Memorial Sloan Kettering Nassau

Uniondale, NY

Open and Accepting

Memorial Sloan Kettering Westchester

West Harrison, NY

Open and Accepting

North Carolina

Novant Health Presbyterian Medical Center Novant Health

Charlotte, NC

Not Yet Accepting

Ohio

Oregon

Oregon Health and Science University OHSU Knight Cancer Institute

Portland, OR

Open and Accepting

Pennsylvania

Tennessee

Vanderbilt-Ingram Cancer Center Henry-Joyce Cancer Clinic

Nashville, TN

Open and Accepting

Texas

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting
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