Open-label Extension Study of Navitoclax in Subjects With Chronic Lymphocytic Leukemia (CLL)
Status: | Completed |
---|---|
Conditions: | Blood Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 10/21/2012 |
Start Date: | June 2012 |
End Date: | June 2013 |
Contact: | Melissa Shah, BS |
Email: | melissa.shah@abbott.com |
Phone: | (847) 938-3885 |
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).
This is an open-label extension study of navitoclax in subjects with chronic lymphocytic
leukemia (CLL).
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.
We found this trial at
5
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