Myeloproliferative neoplasms (MPN)
Ruxolitinib (INCB018424) in participants with primary myelofibrosis (PMF), post essential thrombocythemia-myelofibrosis and post polycythemia vera-myelofibrosis (PPV-MF)
Incyte Study ID:
INCB18424-258
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Clinical Study Purpose
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.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Jun 2011 - Dec 2018
TYPE
Interventional
PHASE
Phase 2
SEX
Female & Male
AGE
18+ years
ACCEPTS HEALTHY VOLUNTEERS
No
Clinical Study Locations
Name
Contact UsName
Birmingham, AL, US
Name
Beverly Hills, CA, US
Name
Burbank, CA, US
Name
La Jolla, CA, US
Name
Los Angeles, CA, US
Name
Pomona, CA, US
Key Inclusion and Exclusion 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
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
Protocol Summary
Incyte Study ID:
INCB18424-258
Primary Purpose:
Treatment
Allocation:
N/A
Study Design:
Single Group Assignment
Masking:
None (Open Label)
Interventions:
Drug
Enrollment:
66
Primary Outcome
Open
Secondary Outcome
Open