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

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ClinicalTrials.gov Identifier: NCT00481091
Recruitment Status : Active, not recruiting
First Posted : June 1, 2007
Last Update Posted : April 25, 2018
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: ABT-263 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Actual Study Start Date : July 25, 2007
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : September 4, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Pharmacokinetic profile evaluation [ Time Frame: Repeating sequence of 14 days on therapy and 7 days off therapy OR 21 days of continuous dosing ]
  2. Preliminary efficacy assessment (Phase 2a) [ Time Frame: Repeating cycles of 21 days continuous dosing ]
  3. Safety assessment [ Time Frame: Repeating sequence of 14 days on therapy and 7 days off therapy OR 21 days of continuous dosing ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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
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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
La Jolla, California, United States, 92037
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Nebraska
Univ Nebraska Med Ctr
Omaha, Nebraska, United States, 68198
United States, New York
North Shore University Hospital
New Hyde Park, New York, United States, 11040
United States, Texas
Univ TX, MD Anderson
Houston, Texas, United States, 77030
United States, Washington
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Australia, Victoria
Peter MacCallum Cancer Ctr
Melbourne, Victoria, Australia, 3000
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Germany
Uniklinik Koln
Köln, Nordrhein-Westfalen, Germany, 50937
United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Genentech, Inc.
Investigators
Study Director: AbbVie Inc. AbbVie
More Information
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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 Posted: June 1, 2007    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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