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

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 2


Study Type:	Interventional
Study Design:	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: Chronic Lymphocytic Leukemia Leukemia

Genetic and Rare Diseases Information Center resources: Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic

U.S. FDA Resources

Further study details as provided by AbbVie:

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 2016
Estimated Primary Completion Date:	October 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
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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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, 11042
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 5WW

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Genentech, Inc.

Investigators


Study Director:	Sari Enschede, MD	AbbVie

More Information

No publications provided


Responsible Party:	AbbVie ( AbbVie (prior sponsor, 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:	October 2, 2014
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 Immune System Diseases Immunoproliferative Disorders	Leukemia, B-Cell Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 27, 2015