View Clinical Trial (Medical Research Study)
A Phase 1/2a Study of ABT-263 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia - NCT00481091-92093(Clinical Trial 171152)
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La Jolla |
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State:
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CA |
| Zip Code: |
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92093 |
| Conditions: |
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Chronic Lymphocytic Leukemia |
| Purpose: |
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The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of
ABT-263 under two different dosing schedules with the objective of defining the dose
limiting toxicity and maximum tolerated dose.
The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2
dose to obtain additional safety information and a preliminary assessment of efficacy.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Relapsed or refractory Chronic Lymphocytic Leukemia and require treatment in opinion
of investigator.
- Eastern Cooperative Oncology Group (ECOG) performance score < or = 1
- Adequate bone marrow independent of growth factor support, renal and hepatic function
per defined laboratory criteria.
Exclusion Criteria:
- Has a history or is clinically suspicious for cancer-related Central Nervous System
(CNS) disease
- Receipt of allogenic or autologous stemcell transplant
- Recent history (within 1 year of first dose) of underlying, predisposing condition of
bleeding or currently exhibits signs of bleeding
- Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis
- Active immune thrombocytopenic purpura or history of being refractory to platelet
transfusions (within 1 year of first dose) |
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| Study is available at: |
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Site Reference # / Investigator 5566
La Jolla, CA 92093
United States
Primary Contact:
Diane D'Amico, BS
Email: diane.damico@abbott.com
Phone: 847-937-5029 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
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