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

July 2, 2014 updated by: AbbVie (prior sponsor, Abbott)

An Extension Study of Navitoclax (ABT-263) in Subjects With Chronic Lymphocytic Leukemia (CLL)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Coburg, Australia, 3058
        • Site Reference ID/Investigator# 79201
      • Greenslopes, Australia, 4120
        • Site Reference ID/Investigator# 78993
  • Israel
      • Afula, Israel, 18101
        • Site Reference ID/Investigator# 77860
      • Rechovot, Israel, 76100
        • Site Reference ID/Investigator# 77637
  • Poland
      • Gdansk, Poland, 80-952
        • Site Reference ID/Investigator# 77413
  • Ukraine
      • Ivano-Frankivsk, Ukraine, 76008
        • Site Reference ID/Investigator# 79203
      • Khmelnitsky, Ukraine, 29000
        • Site Reference ID/Investigator# 79205
      • Kyiv, Ukraine, 03115
        • Site Reference ID/Investigator# 79202
      • Lviv, Ukraine, 79044
        • Site Reference ID/Investigator# 79204
      • Poltava, Ukraine, 36024
        • Site Reference ID/Investigator# 79206
  • United States
    • California
      • La Jolla, California, United States, 92093-0698
        • Site Reference ID/Investigator# 74036
      • Los Angeles, California, United States, 90095-7059
        • Site Reference ID/Investigator# 74035
      • Pleasant Hill, California, United States, 94523
        • Site Reference ID/Investigator# 74038
      • Santa Maria, California, United States, 93454
        • Site Reference ID/Investigator# 74039
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Site Reference ID/Investigator# 74033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Navitoclax, ABT-263
Drug: Navitoclax
QD
Other Names:
  • ABT-263

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.
Time Frame: 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.
Adverse events occuring through the Final Visit (up to Week 52) will be reported
Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety.
Time Frame: Change from baseline through Final Visit (up to Week 52).
Physical exam, blood pressure, pulse, body temperature will be measured and recorded
Change from baseline through Final Visit (up to Week 52).
Safety: Clinical Lab Tests will be performed for each participant as a safety measure.
Time Frame: 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.
Change from baseline through Final Visit (up to Week 52).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Director: Mack Mabry, MD, AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

March 16, 2012

First Posted (Estimate)

March 20, 2012

Study Record Updates

Last Update Posted (Estimate)

July 4, 2014

Last Update Submitted That Met QC Criteria

July 2, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M13-641
  • 2012-000606-29 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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