A Phase 1/2a Study of ABT-263 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia - Full Text View

Sponsor:	Abbott
Collaborator:	Genentech
Information provided by (Responsible Party):	Abbott
ClinicalTrials.gov Identifier:	NCT00481091

Purpose

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 three years after the last subject transitions with less frequent study evaluations.

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia	Drug: ABT-263	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Leukemia

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Determination of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) [ Time Frame: 14 days on therapy and 7 days off therapy OR 21 days continuous dosing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetic profile evaluation [ Time Frame: Repeating sequence of 14 days on therapy and 7 days off therapy OR 21 days of continuous dosing ] [ Designated as safety issue: No ]
Preliminary efficacy assessment (Phase 2a) [ Time Frame: Repeating cycles of 21 days continuous dosing ] [ Designated as safety issue: No ]
Safety assessment [ Time Frame: Repeating sequence of 14 days on therapy and 7 days off therapy OR 21 days of continuous dosing ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	72
Study Start Date:	July 2007
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm NA, Group is Applicable Group/Cohort Number or Label is numerical and sequential starting with dose level 1	Drug: ABT-263 Phase 1 dosing under two different schedules: 14 days on drug, 7 days or (14/21) or continuous dosing. Phase 2a dosing at the recommended phase 2a dose and schedule Other Name: ABT-263

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Relapsed or refractory Chronic Lymphocytic Leukemia and require treatment in opinion of investigator

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481091

Locations

United States, California
Site Reference ID/Investigator# 5566
La Jolla, California, United States, 92093-0820
United States, Massachusetts
Site Reference ID/Investigator# 5547
Boston, Massachusetts, United States, 02115
United States, Nebraska
Site Reference ID/Investigator# 12261
Omaha, Nebraska, United States, 68198-7680
United States, New York
Site Reference ID/Investigator# 12267
New Hyde Park, New York, United States, 11040
United States, Texas
Site Reference ID/Investigator# 5575
Houston, Texas, United States, 77030-4009
United States, Washington
Site Reference ID/Investigator# 26428
Tacoma, Washington, United States, 98405
Australia
Site Reference ID/Investigator# 6583
East Melbourne, Australia, 3002
Site Reference ID/Investigator# 5576
Parkville, Australia, 3050
Germany
Site Reference ID/Investigator# 5924
Cologne, Germany, 50937
United Kingdom
Site Reference ID/Investigator# 15081
Leicester, United Kingdom, LE1 9HN

Sponsors and Collaborators

Abbott

Genentech

Investigators

Study Director:

Sari Enschede, MD

Abbott

More Information

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT00481091 History of Changes
Other Study ID Numbers:	M06-873, 2007-002143-25
Study First Received:	May 30, 2007
Last Updated:	December 27, 2011
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms

Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012