A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma
Status: | Active, not recruiting |
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Conditions: | Blood Cancer, Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 11/22/2018 |
Start Date: | June 14, 2011 |
End Date: | November 14, 2019 |
This is a Phase 1, open-label, multicenter study evaluating the safety and PK profile of
ABT-199 under a once daily dosing schedule. Two arms will be implemented for dose escalation:
Arm A, CLL/SLL subjects and Arm B, NHL subjects. Arm A is designed to enroll approximately
116 subjects with relapsed or refractory CLL or SLL and Arm B is designed to enroll
approximately 95 subjects with relapsed or refractory NHL. Fifty-six subjects were enrolled
in Arm A and approximately 55 subjects will be enrolled in Arm B during the dose escalation
portion of the study, with the objective of defining dose limiting toxicities (DLTs) and the
MTD. Once the MTD is declared for the arm, approximately 60 additional CLL/SLL subjects in
Arm A and approximately 20 additional DLBCL subjects and 20 additional follicular lymphoma
subjects in Arm B will be enrolled in an expanded safety portion of the study at the
recommended phase 2 dose (RPTD) and schedule.
ABT-199 under a once daily dosing schedule. Two arms will be implemented for dose escalation:
Arm A, CLL/SLL subjects and Arm B, NHL subjects. Arm A is designed to enroll approximately
116 subjects with relapsed or refractory CLL or SLL and Arm B is designed to enroll
approximately 95 subjects with relapsed or refractory NHL. Fifty-six subjects were enrolled
in Arm A and approximately 55 subjects will be enrolled in Arm B during the dose escalation
portion of the study, with the objective of defining dose limiting toxicities (DLTs) and the
MTD. Once the MTD is declared for the arm, approximately 60 additional CLL/SLL subjects in
Arm A and approximately 20 additional DLBCL subjects and 20 additional follicular lymphoma
subjects in Arm B will be enrolled in an expanded safety portion of the study at the
recommended phase 2 dose (RPTD) and schedule.
Interventional Study Design - Primary Purpose: Determination of safety and tolerability.
Inclusion Criteria:
- Subject must have either:
- (Arm A) relapsed or refractory CLL/SLL and require treatment in the opinion of
the Investigator. Subject must have relapsed following or be refractory to
standard treatments such as fludarabine based regimens (F, FC, FR, FCR) or
alkylator (chlorambucil, bendamustine) based regimens. In addition, there are no
other curative options, and the subject has exhausted options that would be
considered standard of care, or
- (Arm B) relapsed or refractory NHL and require treatment in the opinion of the
Investigator. Subject must have histologically documented diagnosis of NHL as
defined in the World Health Organization classification scheme, except as noted
in the exclusion criteria. Subject must have relapsed following or be refractory
to standard treatments such as R-CHOP, R-CVP, or fludarabine based regimens. In
addition, there are no other curative options, and the subject has exhausted
options that would be considered standard of care. Subjects with other
lymphoproliferative diseases can be considered in consultation with the Abbott
medical monitor.
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance score less than
or equal to 1.
- Subject must have adequate bone marrow independent of growth factor support per local
laboratory reference range at Screening.
- Subject must have adequate coagulation, renal, and hepatic function, per laboratory
reference range at Screening.
Exclusion Criteria:
- CLL subject has undergone an allogeneic or autologous stem cell transplant or NHL
subject has undergone an allogeneic stem cell transplant or has been diagnosed with
Post-Transplant Lymphoproliferative Disease, Burkitt's lymphoma, Burkitt-like
lymphoma, or lymphoblastic lymphoma/leukemia.
- Subject has tested positive for HIV.
- Subject has a cardiovascular disability status of New York Heart Association Class
greater or equal to 2. Class 2 is defined as cardiac disease in which patients are
comfortable at rest but ordinary physical activity, results in fatigue, palpitations,
dyspnea or anginal pain.
- Subject has a significant history of renal, neurologic, psychiatric, pulmonary,
endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the
opinion of the Investigator would adversely affect his/her participating in this
study.
- Subject has received a monoclonal antibody for anti-neoplastic intent within 8 weeks
prior to the first dose of study drug.
We found this trial at
9
sites
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600 Highland Avenue
Madison, Wisconsin 53705
Madison, Wisconsin 53705
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