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| Sponsor: | Astex Therapeutics |
|---|---|
| Information provided by: | Astex Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00522990 |
Purpose
The goal of this clinical research study is to find the highest tolerable dose of AT9283 that can be given to patients who have ALL, AML, CML, high-risk myelodysplastic syndromes, or myelofibrosis with myeloid metaplasia. Researchers want to perform pharmacokinetic (PK) testing on blood to find out how quickly the study drug leaves the body and how the body breaks down the drug. The safety and effectiveness of this drug will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Chronic Myeloid Leukemia Myelodysplastic Syndromes Myelofibrosis |
Drug: AT9283 |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase I/IIa Open-label Study to Assess the Safety, Tolerability and Preliminary Efficacy of AT9283, a Small Molecule Inhibitor of Aurora Kinases, in Patients With Refractory Hematological Malignancies |
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Refractory Hematological Malignancies
|
Drug: AT9283
Three weekly intravenous administration of AT9283
|
Dose escalation study of AT9283 administered to patients with refractory hematological malignancies. Study objectives include identification of MTD and dose limiting toxicities, preliminary assessment of efficacy and definition of pharmacokinetic profile
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histological or cytological confirmation of one of the following:
Relapsed or refractory AML or ALL; acute leukaemia in patients who are unsuitable for or refuse standard therapy
CML in chronic phase, accelerated phase or blast crisis that is resistant or refractory to standard therapy
High-risk MDS, defined as the presence of:
i)Refractory anemia with excess blasts (RAEB, 5-19% bone marrow blasts)
or
ii)RAEB in transformation to AML (RAEBT with 20-30% bone marrow blasts)
Advanced MMM defined by the presence of one or more of the following features:
i)Hemoglobin < 10 gm/dL (100 g/L)
ii)Platelet count < 100 x 109/L
iii)White blood cell count < 4 x 109/L
iv)Symptomatic splenomegaly or other disease-related symptoms inadequately controlled by conventional therapies
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: James Foran, MD 205-934-2721 james.foran@ccc.uab.edu | |
| Principal Investigator: James M Foran, MD | |
| United States, Texas | |
| The University of Texas, MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Hagop M Kantarjian, MD 713-792-6161 | |
| Principal Investigator: Hagop M Kantarjian, MD | |
| Principal Investigator: | Hagop Kantarjian, MD | The University of Texas M. D. Anderson Cancer Center (MDACC) |
More Information
| Responsible Party: | Astex ( Murray Yule ) |
| Study ID Numbers: | AT9283/0002, 2006-0177 |
| Study First Received: | August 29, 2007 |
| Last Updated: | January 15, 2010 |
| ClinicalTrials.gov Identifier: | NCT00522990 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Myelofibrosis Leukemia, Lymphoid Disease Immunoproliferative Disorders Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Precancerous Conditions Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Leukemia, Myeloid |
Leukemia, Myeloid, Acute Myeloid Metaplasia Lymphatic Diseases Leukemia Neoplasms Preleukemia Pathologic Processes Syndrome Leukemia, Myelogenous, Chronic, BCR-ABL Positive Lymphoproliferative Disorders Bone Marrow Diseases Splenic Diseases |