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Sponsored by: |
Incyte Corporation |
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Information provided by: | Incyte Corporation |
ClinicalTrials.gov Identifier: | NCT00726232 |
To evaluate the safety and efficacy profile of different treatment regimens of INCB018424 administered to two groups of patients; those with polycythemia vera (PV) and those with essential thrombocythemia (ET). Patients in each group will be refractory to hydroxyurea or for whom hydroxyurea is contraindicated.
Condition | Intervention | Phase |
---|---|---|
Polycythemia Vera Essential Thrombocythemia |
Drug: INCB018424 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Study to Determine the Safety and Efficacy of INCB018424 in Patients With Advanced Polycythemia Vera or Essential Thrombocythemia Refractory to Hydroxyurea |
Estimated Enrollment: | 105 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: INCB018424
Treatment Arm 1 - 10mg BID
|
2: Experimental |
Drug: INCB018424
Treatment Arm 2 - 25mg BID
|
3: Experimental |
Drug: INCB018424
Treatment Arm 3 - 50mg QD
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: William Garrett, MBA | 302-498-6987 | wgarrett@incyte.com |
United States, Texas | |
Recruiting | |
Houston, Texas, United States, 77030 |
Study Director: | Edward Bradley, MD | Incyte Corporation |
Responsible Party: | Incyte Corporation ( Pamela Murphy, VP Communications & IR ) |
Study ID Numbers: | INCB 18424-256 |
Study First Received: | July 29, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00726232 |
Health Authority: | United States: Food and Drug Administration |
Polycythemia Polycythemia Vera Essential thrombocytosis Hydroxyurea Hematologic Diseases Blood Coagulation Disorders Blood Platelet Disorders Myeloproliferative Disorders |
Polycythemia vera Hemostatic Disorders Thrombocytopathy Hemorrhagic Disorders Hemorrhagic thrombocythemia Thrombocytosis Thrombocythemia, Hemorrhagic Bone Marrow Diseases |