Clinical trial NCT01557777: Open-label Extension Study of Navitoclax in Subjects With Chronic Lymphocytic Leukemia (CLL)
Official title: An Extension Study of Navitoclax (ABT-263) in Subjects With Chronic Lymphocytic Leukemia (CLL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-03-20
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Open-label extension study of navitoclax in subjects with chronic lymphocytic leukemia (CLL).

Detailed description: This is an open-label extension study of navitoclax in subjects with chronic lymphocytic leukemia (CLL).

Eligibility criteria: Inclusion Criteria:

* The subject has been dosing in Arm C of the ABT4710n study, has not discontinued for any reason prior to study closure and the investigator believes that continued treatment with navitoclax is in the best interest of the subject
* 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 discontinued navitoclax administration in Arm C of the ABT4710n study for reasons of disease progression, Adverse Event toxicity, withdrawal of consent or Investigator decision prior to study completion.
* 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.

Primary outcomes:
measure: Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.
timeFrame: Adverse events occuring through the Final Visit (up to Week 52) will be reported
measure: Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety.
timeFrame: Change from baseline through Final Visit (up to Week 52).
measure: Safety: Clinical Lab Tests will be performed for each participant as a safety measure.
timeFrame: Change from baseline through Final Visit (up to Week 52).
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Site Reference ID/Investigator# 74036
state: California
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 74035
state: California
city: Pleasant Hill
country: United States
facility: Site Reference ID/Investigator# 74038
state: California
city: Santa Maria
country: United States
facility: Site Reference ID/Investigator# 74039
state: California
city: Bethesda
country: United States
facility: Site Reference ID/Investigator# 74033
state: Maryland
city: Coburg
country: Australia
facility: Site Reference ID/Investigator# 79201
city: Greenslopes
country: Australia
facility: Site Reference ID/Investigator# 78993
city: Afula
country: Israel
facility: Site Reference ID/Investigator# 77860
city: Rechovot
country: Israel
facility: Site Reference ID/Investigator# 77637
city: Gdansk
country: Poland
facility: Site Reference ID/Investigator# 77413
city: Ivano-Frankivsk
country: Ukraine
facility: Site Reference ID/Investigator# 79203
city: Khmelnitsky
country: Ukraine
facility: Site Reference ID/Investigator# 79205
city: Kyiv
country: Ukraine
facility: Site Reference ID/Investigator# 79202
city: Lviv
country: Ukraine
facility: Site Reference ID/Investigator# 79204
city: Poltava
country: Ukraine
facility: Site Reference ID/Investigator# 79206
Study officials:
affiliation: AbbVie
name: Mack Mabry, MD
role: STUDY_DIRECTOR
References: