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Open-label Extension Study of Navitoclax in Subjects With Chronic Lymphocytic Leukemia (CLL)

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Navitoclax
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site Reference ID/Investigator# 74036
  • Site Reference ID/Investigator# 74035
  • Site Reference ID/Investigator# 74038
  • Site Reference ID/Investigator# 74039
  • Site Reference ID/Investigator# 74033
  • Site Reference ID/Investigator# 79201
  • Site Reference ID/Investigator# 78993
  • Site Reference ID/Investigator# 77860
  • Site Reference ID/Investigator# 77637
  • Site Reference ID/Investigator# 77413
  • Site Reference ID/Investigator# 79203
  • Site Reference ID/Investigator# 79205
  • Site Reference ID/Investigator# 79202
  • Site Reference ID/Investigator# 79204
  • Site Reference ID/Investigator# 79206

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Navitoclax, ABT-263

Arm Description

Outcomes

Primary Outcome Measures

Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.
The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis through out the study. The investigators will question each subject regarding any adverse effects that they have experienced and record any events on the care report forms. All adverse events will be followed to a satisfactory clinical resolution.
Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety.
Physical exam, blood pressure, pulse, body temperature will be measured and recorded
Safety: Clinical Lab Tests will be performed for each participant as a safety measure.
Chemistry, hematology, urinalysis lab tests will be measured and recorded. All clinically significant values will be followed by the investigator to a satisfactory clinical resolution.

Secondary Outcome Measures

Full Information

First Posted
March 16, 2012
Last Updated
July 2, 2014
Sponsor
AbbVie (prior sponsor, Abbott)
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1. Study Identification

Unique Protocol Identification Number
NCT01557777
Brief Title
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Navitoclax, ABT-263
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Navitoclax
Other Intervention Name(s)
ABT-263
Intervention Description
QD
Primary Outcome Measure Information:
Title
Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.
Description
The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis through out the study. The investigators will question each subject regarding any adverse effects that they have experienced and record any events on the care report forms. All adverse events will be followed to a satisfactory clinical resolution.
Time Frame
Adverse events occuring through the Final Visit (up to Week 52) will be reported
Title
Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety.
Description
Physical exam, blood pressure, pulse, body temperature will be measured and recorded
Time Frame
Change from baseline through Final Visit (up to Week 52).
Title
Safety: Clinical Lab Tests will be performed for each participant as a safety measure.
Description
Chemistry, hematology, urinalysis lab tests will be measured and recorded. All clinically significant values will be followed by the investigator to a satisfactory clinical resolution.
Time Frame
Change from baseline through Final Visit (up to Week 52).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mack Mabry, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 74036
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0698
Country
United States
Facility Name
Site Reference ID/Investigator# 74035
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7059
Country
United States
Facility Name
Site Reference ID/Investigator# 74038
City
Pleasant Hill
State/Province
California
ZIP/Postal Code
94523
Country
United States
Facility Name
Site Reference ID/Investigator# 74039
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Site Reference ID/Investigator# 74033
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Site Reference ID/Investigator# 79201
City
Coburg
ZIP/Postal Code
3058
Country
Australia
Facility Name
Site Reference ID/Investigator# 78993
City
Greenslopes
ZIP/Postal Code
4120
Country
Australia
Facility Name
Site Reference ID/Investigator# 77860
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Site Reference ID/Investigator# 77637
City
Rechovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Site Reference ID/Investigator# 77413
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Site Reference ID/Investigator# 79203
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Site Reference ID/Investigator# 79205
City
Khmelnitsky
ZIP/Postal Code
29000
Country
Ukraine
Facility Name
Site Reference ID/Investigator# 79202
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Site Reference ID/Investigator# 79204
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
Site Reference ID/Investigator# 79206
City
Poltava
ZIP/Postal Code
36024
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

Open-label Extension Study of Navitoclax in Subjects With Chronic Lymphocytic Leukemia (CLL)

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