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Trial Title:
A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms
NCT ID:
NCT06313593
Condition:
Myeloproliferative Neoplasms
Conditions: Official terms:
Neoplasms
Myeloproliferative Disorders
Conditions: Keywords:
Myeloproliferative Neoplasms
INCB160058
Myelofibrosis
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
INCB160058
Description:
Oral; Tablet
Arm group label:
Part 1 Dose Escalation - with MF
Arm group label:
Part 2 Dose Expansion - with MF
Summary:
This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of
INCB160058 in Participants With Myeloproliferative Neoplasms.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford University
Address:
City:
Palo Alto
Zip:
94304
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
The University of Kansas Cancer Center Kucc University of Kansas Clinical Research Center
Address:
City:
Fairway
Zip:
66205
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Withdrawn
Facility:
Name:
Icahn School of Medicine At Mount Sinai
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Recruiting
Facility:
Name:
Sloan Kettering Institute For Cancer Research
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Oregon Health & Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Vanderbilt-Ingram Cancer Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Md Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Start date:
August 8, 2024
Completion date:
September 4, 2027
Lead sponsor:
Agency:
Incyte Corporation
Agency class:
Industry
Source:
Incyte Corporation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06313593
