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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Cephalon |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00494585 |
Purpose
The goal of this clinical research study is to find out if CEP-701 can help control myelofibrosis (MF). The safety of CEP-701 will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Myelofibrosis |
Drug: CEP-701 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of CEP-701, an Orally Available JAK2 Tyrosine Kinase Inhibitor, as a Therapy for Patients With Myelofibrosis |
| Enrollment: | 27 |
| Study Start Date: | June 2007 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CEP-701
80 mg orally twice a day for 30 days
|
Drug: CEP-701
80 mg orally twice a day for 30 days
Other Name: lestaurtinib
|
Show Detailed Description
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, Texas | |
| The University of Texas M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Srdan Verstovsek, M.D. | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00494585 History of Changes |
| Other Study ID Numbers: | 2007-0070, CS-2007-20040 |
| Study First Received: | June 28, 2007 |
| Results First Received: | April 7, 2011 |
| Last Updated: | April 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
CEP-701 Leukemia Myelofibrosis MF JAK2 |
Tyrosine Kinase Inhibitor Lestaurtinib Chronic Idiopathic Myelofibrosis CIMF |
|
Primary Myelofibrosis Leukemia Myeloproliferative Disorders Bone Marrow Diseases |
Hematologic Diseases Neoplasms by Histologic Type Neoplasms |