Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion

Description

Summary

The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of ABT-263 under two different dosing schedules with the objective of defining the dose limiting toxicity and maximum tolerated dose. The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy. The Extension Study portion will allow active subjects to continue to receive ABT-263 for up to 11 years after the last subject transitions with less frequent study evaluations.

Official Title

A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia Chronic Lymphocytic Leukemia (CLL) Navitoclax ABT-263 Cancer Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell

Eligibility

You can join if…

Open to people ages 18 years and up

  • Relapsed or refractory Chronic Lymphocytic Leukemia and require treatment in opinion of investigator.
  • Eastern Cooperative Oncology Group (ECOG) <= 1.
  • Adequate bone marrow independent of growth factor support, renal and hepatic function per defined laboratory criteria.

You CAN'T join if...

  • History or is clinically suspicious for cancer-related Central Nervous System disease.
  • Receipt of allogenic or autologous stem cell transplant.
  • Recent history (within 1 year of first dose) of underlying, predisposing condition of bleeding or currently exhibits signs of bleeding.
  • Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
  • Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions (within 1 year of first dose).

Locations

  • Thornton Hospital - UC San Diego Medical Center /ID# 5566
    La Jolla California 92037 United States
  • Northwest Medical Specialties /ID# 26428
    Tacoma Washington 98405 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT00481091
Phase
Phase 1/2
Study Type
Interventional
Last Updated