RECRUITING

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

Conditions

Myeloproliferative Neoplasms INCB160058 Myelofibrosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-08-08

Study Completion:2027-09-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06313593

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463

medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423

eumedinfo@incyte.com

Principal Investigator

Incyte Medical

STUDY_DIRECTOR

Incyte Corporation

Study Locations (Sites)

Stanford University

Palo Alto, California, 94304

United States

Northwestern University

Chicago, Illinois, 60611

United States

The University of Kansas Cancer Center Kucc University of Kansas Clinical Research Center

Fairway, Kansas, 66205

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Icahn School of Medicine At Mount Sinai

New York, New York, 10029

United States

Sloan Kettering Institute For Cancer Research

New York, New York, 10065

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232

United States

Md Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Incyte Corporation

Incyte Medical, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-08

Study Completion Date2027-09-04

Study Record Updates

Study Start Date2024-08-08

Study Completion Date2027-09-04

Terms related to this study

Keywords Provided by Researchers

Myeloproliferative Neoplasms
INCB160058
Myelofibrosis

Additional Relevant MeSH Terms

Myeloproliferative Neoplasms