Trials / Terminated
TerminatedNCT00522990
Study to Assess the Safety of Escalating Doses of AT9283, in Patients With Leukemias
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
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Astex Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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
Conditions
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Chronic Myeloid Leukemia
- Myelodysplastic Syndromes
- Myelofibrosis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AT9283 | Three weekly intravenous administration of AT9283 |
Timeline
- Start date
- 2006-09-01
- Primary completion
- 2009-04-01
- Completion
- 2009-04-01
- First posted
- 2007-08-30
- Last updated
- 2024-08-02
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00522990. Inclusion in this directory is not an endorsement.