Myeloproliferative Neoplasms Clinical Trial

Ruxolitinib (INCB018424) in Participants With Primary Myelofibrosis (PMF), Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis (PPV-MF)

Summary

To evaluate the effects of treatment with ruxolitinib (INCB018424) on spleen volume, symptoms and potential side effects in participants with PMF, PPV-MF and PET-MF who have platelet counts of 50 x 10^9/L to 100 x 10^9/L. It is anticipated that individualized dose optimization from the starting ruxolitinib level of 5 mg bid will be associated with reductions in splenomegaly, MF-associated symptoms and inflammatory cytokine levels.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy
Discontinuation of all drugs used to treat underlying MF disease at least 14 days prior to baseline visit
INR <= 1.5 or PTT value < 1.5 x upper limit of normal (ULN) at study entry
Hemoglobin level at least 6.5 g/dL at Screening visit
Willingness to be transfused to treat low hemoglobin levels

Exclusion Criteria:

Females who are pregnant, unable to comply with birth control use to avoid becoming pregnant or breastfeeding
Males who cannot comply with birth control use to avoid fathering a child
Platelet count < 50 x10^9/L or absolute neutrophil count (ANC) < 1 x10^9/L at the Screening visit
Inadequate liver or renal function; Intracranial bleeds or invasive malignancy over the previous 2 years - international normalized ratio (INR) laboratory values cannot be > 1.5 x upper limit of normal at study entry.

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

66

Study ID:

NCT01348490

Recruitment Status:

Completed

Sponsor:

Incyte Corporation

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You


Birmingham Alabama, , United States

Beverly Hills California, , United States

Burbank California, , United States

La Jolla California, , United States

Los Angeles California, , United States

Pomona California, , United States

San Diego California, , United States

New Haven Connecticut, , United States

Fort Myers Florida, , United States

Jacksonville Florida, , United States

Orange City Florida, , United States

Atlanta Georgia, , United States

Augusta Georgia, , United States

Chicago Illinois, , United States

Iowa City Iowa, , United States

Louisville Kentucky, , United States

New Orleans Louisiana, , United States

Baltimore Maryland, , United States

Ann Arbor Michigan, , United States

Southfield Michigan, , United States

Saint Louis Missouri, , United States

Hackensack New Jersey, , United States

Morristown New Jersey, , United States

Somerville New Jersey, , United States

New York New York, , United States

Durham North Carolina, , United States

Hickory North Carolina, , United States

Canton Ohio, , United States

Cleveland Ohio, , United States

Portland Oregon, , United States

Danville Pennsylvania, , United States

Hershey Pennsylvania, , United States

Charleston South Carolina, , United States

Nashville Tennessee, , United States

Houston Texas, , United States

San Antonio Texas, , United States

Salt Lake City Utah, , United States

Burlington Vermont, , United States

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

66

Study ID:

NCT01348490

Recruitment Status:

Completed

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider