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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion 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.

Exclusion Criteria:

  • - 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.
Other protocol-defined Inclusion/Exclusion Criteria may apply.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06313593
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Incyte Corporation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Incyte Medical
Principal Investigator Affiliation Incyte Corporation
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Myeloproliferative Neoplasms
Arms & Interventions

Arms

Experimental: Part 1 Dose Escalation - with MF

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.

Experimental: Part 2 Dose Expansion - with MF

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

Interventions

Drug: - INCB160058

Oral; Tablet

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Incyte Corporation Call Center (US)

[email protected]

1.855.463.3463

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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