Myeloproliferative neoplasms (MPN)
Study to determine the safety and efficacy of INCB018424 in patients with polycythemia vera or essential thrombocythemia
Incyte Study ID:
INCB 18424-256
CT.gov ID:
Eudra ID:
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Clinical Study Purpose
To evaluate the safety and efficacy profile of different treatment regimens of Ruxolitinib (INCB018424) administered to two groups of patients; those with polycythemia vera (PV) and those with essential thrombocythemia (ET). Patients in each group were refractory to hydroxyurea or for whom hydroxyurea is contraindicated.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Aug 2008 - Jun 2010
TYPE
Interventional
PHASE
Phase 2
SEX
Female & Male
AGE
18+ years
ACCEPTS HEALTHY VOLUNTEERS
No
Clinical Study Locations
Name
Contact UsName
Houston, TX, US, 77030
Name
Bergamo, Italy
Name
Firenze, Italy
Name
Pavia, Italy
Key Inclusion and Exclusion Criteria
Inclusion Criteria
- Confirmed diagnosis of polycythemia vera or essential thrombocythemia as determined by treating physician
- Disease refractory to hydroxyurea or for whom treatment with hydroxyurea is contraindicated or have refused further treatment with hydroxyurea due to side effects.
Exclusion Criteria
- Treatment with interferon alpha or anagrelide within 7 days and hydroxyurea within 1 day of starting INCB018424.
- Patients diagnosed with another malignancy unless the malignancy was cervical intraepithelial neoplasia or basal or squamous cell skin cancer and the patient has been disease free for > 3 years
Protocol Summary
Incyte Study ID:
INCB 18424-256
Primary Purpose:
Treatment
Allocation:
Randomized
Study Design:
Parallel Assignment
Masking:
None (Open Label)
Interventions:
Drug
Enrollment:
73
Primary Outcome
Open
Secondary Outcome
Open