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Sponsored by: |
Cephalon |
Information provided by: | Cephalon |
ClinicalTrials.gov Identifier: | NCT00586651 |
This is an 18-week open-label, multicenter study to evaluate the efficacy and tolerability of CEP-701 (lestaurtinib) treatment in patients with Polycythemia Vera (PV) and patients with Essential Thrombocytosis (ET).
Condition | Intervention | Phase |
Polycythemia Vera Essential Thrombocytosis |
Drug: lestaurtinib |
Phase II |
Genetics Home Reference related topics: | hemophilia |
ChemIDplus related topics: | CEP 701 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | An Open-Label Study of Oral CEP-701 in Patients With Polycythemia Vera or Essential Thrombocytosis With the JAK2 V617F Mutation |
Estimated Enrollment: | 40 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
This is an 18-week open-label, multicenter study to evaluate the efficacy and tolerability of CEP-701 (lestaurtinib) treatment at a dosage of 80 mg bid for 18 weeks (126 days) in patients with Polycythemia Vera (PV) who have abnormal baseline neutrophil counts or require hydroxyurea therapy and patients with Essential Thrombocytosis (ET) who require hydroxyurea therapy for disease control.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with PV have at least 1 of the following risk factors:
Exclusion Criteria:
Contact: Cephalon Contact | 1-800-283-4396 |
United States, Maryland | |||||
Johns Hopkins University | Recruiting | ||||
Baltimore, Maryland, United States, 21231 | |||||
Contact: Cedron Williams | |||||
Principal Investigator: Alison Moliterno, MD | |||||
United States, New York | |||||
NY Presbyterian-Cornell | Recruiting | ||||
New York City, New York, United States, 10021 | |||||
Contact: Diane Lancaster, RN | |||||
Principal Investigator: Gail Roboz, MD | |||||
United States, Pennsylvania | |||||
University of Pennsylvania | Recruiting | ||||
Philadelphia, Pennsylvania, United States, 19104 | |||||
Principal Investigator: Selina Luger, MD |
Cephalon |
Responsible Party: | Cephalon Oncology ( Sponsor's Medical Expert ) |
Study ID Numbers: | C0701/2030/ON/US |
First Received: | December 21, 2007 |
Last Updated: | June 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00586651 |
Health Authority: | United States: Food and Drug Administration |
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