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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557777
• Other study ID #: M13-641
• Secondary ID: 2012-000606-29
• Status: Completed
• Phase: Phase 2
• First received: March 16, 2012
• Last updated: July 2, 2014
• Start date: June 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationUkraine: Ministry of HealthIsrael: Israeli Health Ministry Pharmaceutical AdministrationPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsItaly: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Navitoclax
QD

Locations

Country	Name	City	State
Australia	Site Reference ID/Investigator# 79201	Coburg
Australia	Site Reference ID/Investigator# 78993	Greenslopes
Israel	Site Reference ID/Investigator# 77860	Afula
Israel	Site Reference ID/Investigator# 77637	Rechovot
Poland	Site Reference ID/Investigator# 77413	Gdansk
Ukraine	Site Reference ID/Investigator# 79203	Ivano-Frankivsk
Ukraine	Site Reference ID/Investigator# 79205	Khmelnitsky
Ukraine	Site Reference ID/Investigator# 79202	Kyiv
Ukraine	Site Reference ID/Investigator# 79204	Lviv
Ukraine	Site Reference ID/Investigator# 79206	Poltava
United States	Site Reference ID/Investigator# 74033	Bethesda	Maryland
United States	Site Reference ID/Investigator# 74036	La Jolla	California
United States	Site Reference ID/Investigator# 74035	Los Angeles	California
United States	Site Reference ID/Investigator# 74038	Pleasant Hill	California
United States	Site Reference ID/Investigator# 74039	Santa Maria	California

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

United States,  Australia,  Israel,  Poland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Adverse events occuring through the Final Visit (up to Week 52) will be reported	Yes
Primary	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	Change from baseline through Final Visit (up to Week 52).	Yes
Primary	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.	Change from baseline through Final Visit (up to Week 52).	Yes