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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Treatments: Navitoclax

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.