|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Incyte Corporation |
|---|---|
| Information provided by: | Incyte Corporation |
| ClinicalTrials.gov Identifier: | NCT00726232 |
Purpose
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Beverly Hills, California, United States | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
| Italy | |
| Bergamo, Italy | |
| Pavia, Italy | |
| Firenze, Italy | |
| Study Director: | Edward Bradley, MD | Incyte Corporation |
More Information
| Responsible Party: | Incyte Corporation ( Pamela Murphy, VP Communications & IR ) |
| Study ID Numbers: | INCB 18424-256 |
| Study First Received: | July 29, 2008 |
| Last Updated: | March 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00726232 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Italy: Ministry of Health |
|
Polycythemia Polycythemia Vera Hydroxyurea Hematologic Diseases Blood Coagulation Disorders Blood Platelet Disorders Myeloproliferative Disorders Hemostatic Disorders |
Thrombocytopathy Hemorrhagic Disorders Thrombocytosis Thrombocythemia, Hemorrhagic Hemorrhagic Thrombocythemia Essential Thrombocytosis Bone Marrow Diseases |
|
Polycythemia Vera Polycythemia Hemorrhagic Disorders Hematologic Diseases Blood Platelet Disorders |
Blood Coagulation Disorders Myeloproliferative Disorders Thrombocytosis Thrombocythemia, Hemorrhagic Bone Marrow Diseases |