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

Myeloproliferative Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06313593
• Other study ID #: INCB160058-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 14, 2024
• Est. completion date: September 4, 2027

Study information

• Verified date: March 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: medinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: September 4, 2027
• Est. primary completion date: June 6, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myeloproliferative Disorders
• Myeloproliferative Neoplasms
• Neoplasms

Intervention

Drug:
• INCB160058
Oral; Tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Dose Limiting Toxicities (DLTs)	Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.	Up to 28 days
Primary	Number of participants with Treatment-emergent Adverse Events (TEAEs)	Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.	Up to 2 years and 30 days
Primary	Number of participants with TEAEs leading to dose modification or discontinuation	Number of participants with TEAEs leading to dose modification or discontinuation.	Up to 2 years and 30 days
Secondary	INCB160058 pharmacokinetic (PK) in Plasma	INCB160058 concentration in plasma.	Up to Day 57
Secondary	Response using the revised IWG-MRT and ELN response criteria for MF	Defined as the percentage of participants with Response using the revised International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) response criteria.	Week 12 and 24 and then every 24 weeks up to 2 years
Secondary	Percentage of participants achieving spleen volume reduction as defined in the protocol	Defined as percentage of participants with a protocol defined Spleen Volume Reduction.	Week 12 and Week 24
Secondary	Percentage of participants achieving = 50% reduction from baseline of total symptom score (TSS)	Defined as the percentage of participants achieving = 50% reduction from baseline of TSS.	Week 24
Secondary	Participants with MF with symptomatic anemia: Anemia Response	For non transfusion-dependent (TD) participants: A hemoglobin increase relative to baseline as defined in the protocol if non-TD at baseline. For TD participants: Achieving transfusion independency (TI) as defined in the protocol.	Up to 2 years and 30 days