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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00481091
First received: May 30, 2007
Last updated: January 7, 2014
Last verified: January 2014
  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:


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 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
  • 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
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, 50924
United Kingdom
Site Reference ID/Investigator# 15081
Leicester, United Kingdom, LE1 5WW
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Genentech
Investigators
Study Director: Sari Enschede, MD AbbVie
  More Information

No publications provided by AbbVie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: January 7, 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
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014