A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
NCT ID: NCT00481091
Last Updated: 2023-06-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2007-07-25
2022-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Navitoclax 14/21 Day Cycle: 10 mg
Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.
ABT-263
Tablet; Oral
Navitoclax 14/21 Day Cycle: 110 mg
Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.
ABT-263
Tablet; Oral
Navitoclax 14/21 Day Cycle: 200 mg
Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.
ABT-263
Tablet; Oral
Navitoclax 14/21 Day Cycle: 250 mg
Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.
ABT-263
Tablet; Oral
Navitoclax 21/21 Day Cycle: 125 mg
Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.
ABT-263
Tablet; Oral
Navitoclax 21/21 Day Cycle: 200 mg
Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.
ABT-263
Tablet; Oral
Navitoclax 21/21 Day Cycle: 250 mg
Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.
ABT-263
Tablet; Oral
Navitoclax 21/21 Day Cycle: 300 mg
Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.
ABT-263
Tablet; Oral
Phase 2: Navitoclax 100 mg
Navitoclax 100 mg in participants with CLL who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).
ABT-263
Tablet; Oral
Phase 2: Navitoclax 250 mg
Navitoclax 250 mg in participants with CLL who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).
ABT-263
Tablet; Oral
Interventions
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ABT-263
Tablet; Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) \<= 1.
* Adequate bone marrow independent of growth factor support, renal and hepatic function per defined laboratory criteria.
Exclusion Criteria
* Receipt of allogenic or autologous stem cell 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).
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Moores Cancer Center at UC San Diego /ID# 5566
La Jolla, California, United States
Dana-Farber Cancer Institute /ID# 5547
Boston, Massachusetts, United States
University of Nebraska Medical Center /ID# 12261
Omaha, Nebraska, United States
North Shore University Hospital /ID# 12267
New Hyde Park, New York, United States
University of Texas MD Anderson Cancer Center /ID# 5575
Houston, Texas, United States
Northwest Medical Specialties - Tacoma /ID# 26428
Tacoma, Washington, United States
Peter MacCallum Cancer Ctr /ID# 6583
Melbourne, Victoria, Australia
The Royal Melbourne Hospital /ID# 5576
Parkville, Victoria, Australia
Universitaetsklinikum Koeln /ID# 5924
Cologne, North Rhine-Westphalia, Germany
Leicester Royal Infirmary /ID# 15081
Leicester, England, United Kingdom
Countries
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References
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Roberts AW, Seymour JF, Brown JR, Wierda WG, Kipps TJ, Khaw SL, Carney DA, He SZ, Huang DC, Xiong H, Cui Y, Busman TA, McKeegan EM, Krivoshik AP, Enschede SH, Humerickhouse R. Substantial susceptibility of chronic lymphocytic leukemia to BCL2 inhibition: results of a phase I study of navitoclax in patients with relapsed or refractory disease. J Clin Oncol. 2012 Feb 10;30(5):488-96. doi: 10.1200/JCO.2011.34.7898. Epub 2011 Dec 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2007-002143-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M06-873
Identifier Type: -
Identifier Source: org_study_id
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