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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01557777
First received: March 16, 2012
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Navitoclax
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Extension Study of Navitoclax (ABT-263) in Subjects With Chronic Lymphocytic Leukemia (CLL)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: Change from baseline through Final Visit (up to Week 52). ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: Change from baseline through Final Visit (up to Week 52). ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 17
Study Start Date: June 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Navitoclax, ABT-263 Drug: Navitoclax
QD
Other Name: ABT-263

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557777

Locations
United States, California
Site Reference ID/Investigator# 74036
La Jolla, California, United States, 92093-0698
Site Reference ID/Investigator# 74035
Los Angeles, California, United States, 90095-7059
Site Reference ID/Investigator# 74038
Pleasant Hill, California, United States, 94523
Site Reference ID/Investigator# 74039
Santa Maria, California, United States, 93454
United States, Maryland
Site Reference ID/Investigator# 74033
Bethesda, Maryland, United States, 20817
Australia
Site Reference ID/Investigator# 79201
Coburg, Australia, 3058
Site Reference ID/Investigator# 78993
Greenslopes, Australia, 4120
Israel
Site Reference ID/Investigator# 77860
Afula, Israel, 18101
Site Reference ID/Investigator# 77637
Rechovot, Israel, 76100
Poland
Site Reference ID/Investigator# 77413
Gdansk, Poland, 80-952
Ukraine
Site Reference ID/Investigator# 79203
Ivano-Frankivsk, Ukraine, 76008
Site Reference ID/Investigator# 79205
Khmelnitsky, Ukraine, 29000
Site Reference ID/Investigator# 79202
Kyiv, Ukraine, 03115
Site Reference ID/Investigator# 79204
Lviv, Ukraine, 79044
Site Reference ID/Investigator# 79206
Poltava, Ukraine, 36024
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Mack Mabry, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01557777     History of Changes
Other Study ID Numbers: M13-641, 2012-000606-29
Study First Received: March 16, 2012
Last Updated: July 2, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Ukraine: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Italy: Ministry of Health

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 23, 2014