Open-label Extension Study of Navitoclax in Subjects With Chronic Lymphocytic Leukemia (CLL)
NCT ID: NCT01557777
Last Updated: 2014-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
17 participants
INTERVENTIONAL
2012-06-30
2013-07-31
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
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Navitoclax, ABT-263
Navitoclax
QD
Interventions
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Navitoclax
QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The subject must meet defined hematology and coagulation lab criteria as specified in the protocol
* The subject must meet defined chemistry criteria as specified in the protocol
* Women of childbearing potential and men must agree to use adequate contraception (as per protocol) prior to study entry, for the duration of study participation and up to 90 days following completion of therapy
* The subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign the Informed Consent Form
Exclusion Criteria
* The subject has any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk for toxicities.
* The subject is a lactating or pregnant female.
18 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Mack Mabry, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 74036
La Jolla, California, United States
Site Reference ID/Investigator# 74035
Los Angeles, California, United States
Site Reference ID/Investigator# 74038
Pleasant Hill, California, United States
Site Reference ID/Investigator# 74039
Santa Maria, California, United States
Site Reference ID/Investigator# 74033
Bethesda, Maryland, United States
Site Reference ID/Investigator# 79201
Coburg, , Australia
Site Reference ID/Investigator# 78993
Greenslopes, , Australia
Site Reference ID/Investigator# 77860
Afula, , Israel
Site Reference ID/Investigator# 77637
Rehovot, , Israel
Site Reference ID/Investigator# 77413
Gdansk, , Poland
Site Reference ID/Investigator# 79203
Ivano-Frankivsk, , Ukraine
Site Reference ID/Investigator# 79205
Khmelnitsky, , Ukraine
Site Reference ID/Investigator# 79202
Kyiv, , Ukraine
Site Reference ID/Investigator# 79204
Lviv, , Ukraine
Site Reference ID/Investigator# 79206
Poltava, , Ukraine
Countries
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Other Identifiers
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2012-000606-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M13-641
Identifier Type: -
Identifier Source: org_study_id
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