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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01557777




Registration number
NCT01557777
Ethics application status
Date submitted
16/03/2012
Date registered
20/03/2012
Date last updated
4/07/2014

Titles & IDs
Public title
Open-label Extension Study of Navitoclax in Subjects With Chronic Lymphocytic Leukemia (CLL)
Scientific title
An Extension Study of Navitoclax (ABT-263) in Subjects With Chronic Lymphocytic Leukemia (CLL)
Secondary ID [1] 0 0
2012-000606-29
Secondary ID [2] 0 0
M13-641
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Navitoclax

Experimental: Navitoclax, ABT-263 -


Treatment: Drugs: Navitoclax
QD

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Adverse events occuring through the Final Visit (up to Week 52) will be reported
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Change from baseline through Final Visit (up to Week 52).
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
Change from baseline through Final Visit (up to Week 52).

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Basic Science
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 79201 - Coburg
Recruitment hospital [2] 0 0
Site Reference ID/Investigator# 78993 - Greenslopes
Recruitment postcode(s) [1] 0 0
3058 - Coburg
Recruitment postcode(s) [2] 0 0
4120 - Greenslopes
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
Israel
State/province [3] 0 0
Afula
Country [4] 0 0
Israel
State/province [4] 0 0
Rechovot
Country [5] 0 0
Poland
State/province [5] 0 0
Gdansk
Country [6] 0 0
Ukraine
State/province [6] 0 0
Ivano-Frankivsk
Country [7] 0 0
Ukraine
State/province [7] 0 0
Khmelnitsky
Country [8] 0 0
Ukraine
State/province [8] 0 0
Kyiv
Country [9] 0 0
Ukraine
State/province [9] 0 0
Lviv
Country [10] 0 0
Ukraine
State/province [10] 0 0
Poltava

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie (prior sponsor, Abbott)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Open-label extension study of navitoclax in subjects with chronic lymphocytic leukemia (CLL).
Trial website
https://clinicaltrials.gov/show/NCT01557777
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mack Mabry, MD
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications