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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:
ClinicalTrials.gov Identifier:
NCT00481091
First Posted: June 1, 2007
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
  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 7 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: Intervention Model: Single Group Assignment
Masking: None (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 ( AbbVie (prior sponsor, 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 ]

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 ]
  • Preliminary efficacy assessment (Phase 2a) [ Time Frame: Repeating cycles of 21 days continuous dosing ]
  • Safety assessment [ Time Frame: Repeating sequence of 14 days on therapy and 7 days off therapy OR 21 days of continuous dosing ]

Estimated Enrollment: 72
Study Start Date: July 25, 2007
Estimated Study Completion Date: August 30, 2018
Estimated Primary Completion Date: August 30, 2018 (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


  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481091


Locations
United States, California
UCSD Moores Cancer Center, US /ID# 5566
La Jolla, California, United States, 92093
United States, Massachusetts
Dana Farber Cancer Institute /ID# 5547
Boston, Massachusetts, United States, 02115
United States, Nebraska
University of Nebraska Medical Center /ID# 12261
Omaha, Nebraska, United States, 68198-7680
United States, New York
North Shore University Hospital /ID# 12267
New Hyde Park, New York, United States, 11042
United States, Texas
The University of Texas - MD Anderson Cancer Center /ID# 5575
Houston, Texas, United States, 77030-4009
United States, Washington
Northwest Medical Specialties, PLLC /ID# 26428
Tacoma, Washington, United States, 98405
Australia
Peter MacCallum Cancer Centre /ID# 6583
East Melbourne, Australia, 3002
Royal Melbourne Hospital /ID# 5576
Parkville, Melbourne, Australia, 3050
Germany
Uniklinik Koln /ID# 5924
Cologne, Germany, 50937
United Kingdom
Leicester Royal Infirmary, Univ Hosp of Leicester NHS /ID# 15081
Leicester, United Kingdom, LE1 5WW
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Genentech, Inc.
Investigators
Study Director: Mack Mabry, MD AbbVie
  More Information

Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00481091     History of Changes
Other Study ID Numbers: M06-873
2007-002143-25 ( EudraCT Number )
First Submitted: May 30, 2007
First Posted: June 1, 2007
Last Update Posted: October 18, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Navitoclax
Antineoplastic Agents