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Tests treatment safety and results for Myeloproliferative Neoplasms
Official title A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms
ClinicalTrials.gov ID: NCT06313593
What this study is testing
What is INCB160058?
INCB160058 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for myeloproliferative neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Intermediate-1 or higher risk PMF, post-PV MF, or post-ET MF with evidence of minimum burden of disease based on splenomegaly, and for the...
- For the MF SubOpt R cohort: Therapeutic regimen prior to enrollment as defined in the protocol and unlikely to benefit from further monotherapy in...
- PV: Confirmed diagnosis of PV and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant...
- ET: Confirmed diagnosis of high-risk ET as defined in the protocol and previously treated with at least 1 prior standard cytoreductive therapy and...
You likely can't join if
- Presence of a hematological malignancy requiring treatment, other than PMF, post-PV MF, post-ET MF, PV, or ET.
- 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.
See the full eligibility criteria
- Age ≥ 18 years
- Intermediate-1 or higher risk PMF, post-PV MF, or post-ET MF with evidence of minimum burden of disease based on splenomegaly, and for the monotherapy cohort, participants must have been previously treated with at least...
- For the MF SubOpt R cohort: Therapeutic regimen prior to enrollment as defined in the protocol and unlikely to benefit from further monotherapy in the opinion of the investigator.
- PV: Confirmed diagnosis of PV and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment.
- ET: Confirmed diagnosis of high-risk ET as defined in the protocol and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to...
- 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.
- Presence of a hematological malignancy requiring treatment, other than PMF, post-PV MF, post-ET MF, PV, or ET.
- 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.
- Acute or chronic HBV, active HCV or known HIV.
- Any prior MPN-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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Palo Alto, California, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Fairway, Kansas, United States
- Ann Arbor, Michigan, United States
- New York, New York, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Paris, France
- Villejuif, France
- Aachen, Germany
- Essen, Germany
- Halle, Germany
- Bologna, Italy
- Florence, Italy
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Palo Alto, California, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Fairway, Kansas, United States; Ann Arbor, Michigan, United States and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.