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

Sponsor
AbbVie (prior sponsor, Abbott) (Industry)
Overall Status
Completed
CT.gov ID
NCT01557777
Collaborator
(none)
17
Enrollment
15
Locations
1
Arm
13
Duration (Months)
1.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
An Extension Study of Navitoclax (ABT-263) in Subjects With Chronic Lymphocytic Leukemia (CLL)
Study Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Navitoclax, ABT-263

Drug: Navitoclax
QD
Other Names:
  • ABT-263

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety. [Adverse events occuring through the Final Visit (up to Week 52) will be reported]

      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.

    2. Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety. [Change from baseline through Final Visit (up to Week 52).]

      Physical exam, blood pressure, pulse, body temperature will be measured and recorded

    3. Safety: Clinical Lab Tests will be performed for each participant as a safety measure. [Change from baseline through Final Visit (up to Week 52).]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site Reference ID/Investigator# 74036 La Jolla California United States 92093-0698
    2 Site Reference ID/Investigator# 74035 Los Angeles California United States 90095-7059
    3 Site Reference ID/Investigator# 74038 Pleasant Hill California United States 94523
    4 Site Reference ID/Investigator# 74039 Santa Maria California United States 93454
    5 Site Reference ID/Investigator# 74033 Bethesda Maryland United States 20817
    6 Site Reference ID/Investigator# 79201 Coburg Australia 3058
    7 Site Reference ID/Investigator# 78993 Greenslopes Australia 4120
    8 Site Reference ID/Investigator# 77860 Afula Israel 18101
    9 Site Reference ID/Investigator# 77637 Rechovot Israel 76100
    10 Site Reference ID/Investigator# 77413 Gdansk Poland 80-952
    11 Site Reference ID/Investigator# 79203 Ivano-Frankivsk Ukraine 76008
    12 Site Reference ID/Investigator# 79205 Khmelnitsky Ukraine 29000
    13 Site Reference ID/Investigator# 79202 Kyiv Ukraine 03115
    14 Site Reference ID/Investigator# 79204 Lviv Ukraine 79044
    15 Site Reference ID/Investigator# 79206 Poltava Ukraine 36024

    Sponsors and Collaborators

    • AbbVie (prior sponsor, Abbott)

    Investigators

    • Study Director: Mack Mabry, MD, AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie (prior sponsor, Abbott)
    ClinicalTrials.gov Identifier:
    NCT01557777
    Other Study ID Numbers:
    • M13-641
    • 2012-000606-29
    First Posted:
    Mar 20, 2012
    Last Update Posted:
    Jul 4, 2014
    Last Verified:
    Jul 1, 2014
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell
    Navitoclax

    Study Results

    No Results Posted as of Jul 4, 2014