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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia

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Trial Information

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


Inclusion Criteria:



- 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

Exclusion Criteria:

- History or 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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of dose limiting toxicity (DLT) and maximum tolerated dose (MTD)

Outcome Time Frame:

14 days on therapy and 7 days off therapy OR 21 days continuous dosing

Safety Issue:

Yes

Principal Investigator

Sari Enschede, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

United States: Food and Drug Administration

Study ID:

M06-873

NCT ID:

NCT00481091

Start Date:

July 2007

Completion Date:

September 2014

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Site Reference ID/Investigator# 5566La Jolla, California  92093-0820
Site Reference ID/Investigator# 5547Boston, Massachusetts  02115
Site Reference ID/Investigator# 12261Omaha, Nebraska  68198-7680
Site Reference ID/Investigator# 12267New Hyde Park, New York  11040
Site Reference ID/Investigator# 5575Houston, Texas  77030-4009
Site Reference ID/Investigator# 26428Tacoma, Washington  98405