A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms

Description

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

Conditions

Myeloproliferative Neoplasms

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Study Overview

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Study Details

Study overview

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

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

A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms

Condition
Myeloproliferative Neoplasms
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Fairway

The University of Kansas Cancer Center Kucc University of Kansas Clinical Research Center, Fairway, Kansas, United States, 66205

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

New York

Icahn School of Medicine At Mount Sinai, New York, New York, United States, 10029

New York

Sloan Kettering Institute For Cancer Research, New York, New York, United States, 10065

Portland

Oregon Health & Science University, Portland, Oregon, United States, 97239

Nashville

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States, 37232

Houston

Md Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age ≥ 18 years
  • * Participants with intermediate-1 or higher risk PMF, post-PV, of post-ET MF, histologically confirmed
  • * Evidence of minimum burden of disease based on symptoms and/or splenomegaly
  • * 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
  • * Previously treated with at least 1 JAK inhibitor for ≥ 12 weeks and resistant, refractory, intolerant to, or have lost response to JAK inhibitor treatment
  • * Presence of a hematological malignancy requiring treatment, other than PMF, post-PV MF, or post-ET MF
  • * 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
  • * Active HBV/HCV or known HIV
  • * Any prior MF-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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Incyte Corporation,

Incyte Medical, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

2027-09-04