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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT06313593
Phase
PHASE1
Status
Recruiting
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Conditions

  • Myeloproliferative Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INCB160058 — DRUG
    Oral; Tablet
  • Standard disease-directed therapy — DRUG
    A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.

Study Details

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

Key Dates

Start date
Aug 8, 2024
Status verified
Apr 2026
Primary completion
Oct 9, 2028
Completion
Oct 9, 2028

Study Design

Enrollment
186 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 Dose Escalation - with MF, PV or ET
    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.
  • Experimental: Part 1 Dose Escalation - with MF SubOpt R
    INCB160058 will be administered at a protocol defined starting regimen and will allow for the evaluation of INCB160058 in combination with a standard disease-directed therapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with myelofibrosis (MF), suboptimal response to a standard disease-directed therapy (SubOpt R) will enroll in this group.
  • Experimental: Part 2 Dose Expansion - with MF, PV or ET
    INCB160058 will be administered at the RDE(s) identified during Part 1. Participants with MF, PV or ET will enroll in this group.
  • Experimental: Part 2 Dose Expansion - with MF SubOpt R
    INCB160058 will be administered as an add-on therapy in combination with a standard disease-directed therapy at the RDE(s) identified during Part 1. Participants with myelofibrosis (MF), suboptimal response to a standard disease-directed therapy (SubOpt R) will enroll in this group.

Primary Outcome Measure

Number of participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
The University of Alabama At BirminghamBirminghamAlabama35249-
Stanford UniversityPalo AltoCalifornia94304-
Moffitt Cancer CenterTampaFlorida33612-
Northwestern UniversityChicagoIllinois60611-
The University of Kansas Cancer Center Kucc University of Kansas Clinical Research CenterFairwayKansas66205-
University of MichiganAnn ArborMichigan48109-5008-
Cornell Medical CenterNew YorkNew York10021-
Icahn School of Medicine At Mount SinaiNew YorkNew York10029-
Sloan Kettering Institute For Cancer ResearchNew YorkNew York10065-
Oregon Health & Science UniversityPortlandOregon97239-
University of Pennsylvania Health SystemPhiladelphiaPennsylvania19104-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
Md Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Birmingham, AL

By research site
The University of Alabama At Birmingham· Birmingham, ALStanford University· Palo Alto, CAMoffitt Cancer Center· Tampa, FLNorthwestern University· Chicago, ILThe University of Kansas Cancer Center Kucc University of Kansas Clinical Research Center· Fairway, KSUniversity of Michigan· Ann Arbor, MI

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