Status:
TERMINATED
Study to Determine the Safety and Efficacy of INCB018424 in Patients With Polycythemia Vera or Essential Thrombocythemia
Lead Sponsor:
Incyte Corporation
Conditions:
Myeloproliferative Neoplasm (MPN)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 essenti...
Detailed Description
The study consisted of a 2-stage design, which included a dose-ranging phase (during which patients received treatment at their randomized dose) and an expansion phase (after adjustment of dose/regime...
Eligibility Criteria
Inclusion
- 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.
- Patient meets baseline clinical lab parameters
Exclusion
- 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
- Patients receiving therapy with intermediate or high dose steroids greater than the equivalent of 10 mg prednisone per day
- Clinically significant cardiac disease (New York Heart Association (NYHA) Class III or IV)
Key Trial Info
Start Date :
August 20 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2018
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00726232
Start Date
August 20 2008
End Date
August 20 2018
Last Update
October 29 2025
Active Locations (4)
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1
Houston, Texas, United States, 77030
2
Bergamo, Italy
3
Florence, Italy
4
Pavia, Italy