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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT number 2005-004243-65 |
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The purpose of this study is to assess safety and tolerability of multiple ascending doses of AZD1152 and to assess effect of AZD1152 on the rate of complete remission in patients with relapsed acute myeloid leukaemia.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1152 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of multiple ascending doses AZD1152 in patients with AML by assessment of AEs, vital signs, ECG parameters, clinical chemistry, haematology (including clotting parameters) and urinalysis. | Assessed at each visit | |
| To determine the rate of complete remission from baseline changes in bone marrow and blood myeloblast counts and recovery of normal haemopoiesis | Change from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the pharmacokinetics, pharmacodynamics, efficacy, safety and tolerability | Assessed at each visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Stockman, MD | AstraZeneca | Study Director |
| Bob Lowenberg, MD, PhD | Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | New York | New York | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21976672 | Derived | Lowenberg B, Muus P, Ossenkoppele G, Rousselot P, Cahn JY, Ifrah N, Martinelli G, Amadori S, Berman E, Sonneveld P, Jongen-Lavrencic M, Rigaudeau S, Stockman P, Goudie A, Faderl S, Jabbour E, Kantarjian H. Phase 1/2 study to assess the safety, efficacy, and pharmacokinetics of barasertib (AZD1152) in patients with advanced acute myeloid leukemia. Blood. 2011 Dec 1;118(23):6030-6. doi: 10.1182/blood-2011-07-366930. Epub 2011 Oct 5. |
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| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C520647 | 2-((3-((4-((5-(2-((3-fluorophenyl)amino)-2-oxoethyl)-1H-pyrazol-3-yl)amino)quinazolin-7-yl)oxy)propyl)(ethyl)amino)ethyl dihydrogen phosphate |
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| Houston |
| Texas |
| United States |
| Research Site | Angers | France |
| Research Site | Grenoble | France |
| Research Site | Le Chesnay | France |
| Research Site | Bologna | Italy |
| Research Site | Roma | Italy |
| Research Site | Amsterdam | Netherlands |
| Research Site | Nijmegen | Netherlands |
| Research Site | Rotterdam | Netherlands |
| D006425 |
| Hemic and Lymphatic Diseases |