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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Cephalon |
| Information provided by: | 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 MF. The safety of CEP-701 will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Myelofibrosis |
Drug: CEP-701 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Evaluation of CEP-701, an Orally Available JAK2 Tyrosine Kinase Inhibitor, as a Therapy for Patients With Myelofibrosis |
| Estimated Enrollment: | 41 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
CEP-701
|
Drug: CEP-701
80mg orally twice a day for 30 days
|
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: | The University of Texas M.D. Anderson Cancer Center ( Srdan Verstovsek, M.D./ Associate Professor ) |
| Study ID Numbers: | 2007-0070, CS-2007-20040 |
| Study First Received: | June 28, 2007 |
| Last Updated: | November 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00494585 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
CEP-701 Leukemia Myelofibrosis MF |
JAK2 Tyrosine Kinase Inhibitor Lestaurtinib |
|
Myeloid Metaplasia Lymphatic Diseases Leukemia Neoplasms Myelofibrosis |
Neoplasms by Histologic Type Hematologic Diseases Myeloproliferative Disorders Bone Marrow Diseases Splenic Diseases |