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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Incyte Corporation |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00674479 |
The goal of this clinical research study is to learn if INCB018424 can help to control advanced hematological malignancies. The safety of this drug will also be studied.
Optional Procedures: You will be asked to allow extra blood to be drawn for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points.
You will be asked to allow extra blood to be drawn for pharmacodynamic (PD) testing. PD testing is used to look at how the study drug in your body may affect the disease.
You will be asked to allow extra blood to be drawn for pharmacodynamic (PD) testing. PD testing is used to look at how the study drug in your body may affect the disease.
Condition | Intervention | Phase |
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Acute Myeloid Leukemia Acute Lymphocytic Leukemia Myelodysplastic Syndrome Chronic Myelogenous Leukemia |
Drug: INCB018424 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of INCB018424 in Patients With Advanced Hematologic Malignancies |
Estimated Enrollment: | 120 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
INCB018424
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Drug: INCB018424
INCB018424 - 25 mg po twice daily.
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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: Farhad Ravandi-Kashani, M.D. | 713/745-0394 | fravandi@mdanderson.org |
United States, Texas | |
The University of Texas M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Farhad Ravandi-Kashani, M.D. 713-745-0394 fravandi@mdanderson.org | |
Principal Investigator: Farhad Ravandi-Kashani, M.D. |
Principal Investigator: | Farhad Ravandi-Kashani, M.D. | 713/745-0394 |
Responsible Party: | The University of Texas M. D. Anderson Cancer Center ( Farhad Ravandi-Kashani, M.D./Associate Professor ) |
Study ID Numbers: | 2007-0925 |
Study First Received: | May 5, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00674479 |
Health Authority: | United States: Food and Drug Administration |
Acute Myeloid Leukemia AML Acute Lymphocytic leukemia ALL Myelodysplastic Syndrome |
MDS Chronic myelogenous leukemia - Blast Crisis CML INCB018424 |
Myelodysplastic syndromes Blast Crisis Leukemia, Lymphoid Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Chronic myelogenous leukemia Precancerous Conditions Hematologic Neoplasms Hematologic Diseases Myelodysplasia Myelodysplastic Syndromes Acute myelogenous leukemia |
Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia Lymphatic Diseases Preleukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases Lymphoproliferative Disorders Acute myelocytic leukemia Lymphoma |
Neoplasms Neoplasms by Site Pathologic Processes Disease |
Neoplasms by Histologic Type Immune System Diseases Syndrome |