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A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia

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.
 
ClinicalTrials.gov Identifier: NCT00481091
Recruitment Status : Active, not recruiting
First Posted : June 1, 2007
Last Update Posted : December 22, 2020
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie

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 11 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential 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 : July 8, 2022
Estimated Study Completion Date : July 8, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase 1: Dose Escalation Portion
Participants will receive escalating doses of ABT-263 to determine the recommended phase 2 dose (RPTD). Eligible participants can continue to receive ABT-263 for 11 years in the extension portion.
Drug: ABT-263
Tablet; Oral
Other Name: Navitoclax

Experimental: Phase 2a: Dose Expansion Portion
Participants will receive ABT-263 at the RPTD determined in Phase 1 portion. Eligible participants can continue to receive ABT-263 for 11 years in the extension portion.
Drug: ABT-263
Tablet; Oral
Other Name: Navitoclax




Primary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: Up to approximately 13 years ]
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.

  2. Number of Participants with Dose Limiting Toxicity (DLT) in the Dose Escalation Phase (Phase 1) [ Time Frame: Cycle 1 (Up to 21 days) ]
    DLTs graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0.

  3. Maximum Tolerated Dose (MTD) in the Dose Escalation Phase (Phase 1) [ Time Frame: Cycle 1 (Up to 21 days) ]
    The MTD will be determined by using available clinical data during dose escalation in phase 1.

  4. Recommended Phase 2 Dose (RPTD) Determined in the Dose Escalation Phase (Phase 1) [ Time Frame: Cycle 1 (Up to 21 days) ]
    The RPTD will be determined based on observed dose-limiting toxicities (DLTs) and/or determination of the maximum tolerated dose (MTD) in phase 1.

  5. Maximum Observed Plasma Concentration (Cmax) of Navitoclax (Phase 1) [ Time Frame: Up to Day 14 ]
    Cmax of navitoclax.

  6. Time to Maximum Observed Plasma Concentration (Tmax) of Navitoclax (Phase 1) [ Time Frame: Up to Day 14 ]
    Tmax of navitoclax.

  7. Terminal phase elimination rate constant (β) for Navitoclax (Phase 1) [ Time Frame: Day 1 ]
    Terminal phase elimination rate constant (β) for navitoclax.

  8. Terminal phase elimination half-life (t1/2) of Navitoclax (Phase 1) [ Time Frame: Day 1 ]
    Terminal phase elimination half-life (t1/2) of navitoclax.

  9. Area Under the Plasma Concentration-time Curve over time from 0 to 24 hours (AUC0-24) of Navitoclax (Phase 1) [ Time Frame: Day 1 ]
    AUC0-24 of navitoclax.

  10. Area Under the Plasma Concentration-time Curve over time from 0 to 8 hours (AUC0-8) of Navitoclax (Phase 1) [ Time Frame: Day 14 ]
    AUC0-8 of navitoclax.

  11. Progression-free Survival (PFS) (Extension Portion) [ Time Frame: Up to approximately 13 years ]
    PFS defined as the time from the date the participant started study drug to the date the participant experiences an event of disease progression.

  12. Overall Survival (OS) (Extension Portion) [ Time Frame: Up to approximately 13 years ]
    OS defined as the time from the date the participant started study drug to the date the participant's death.



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Ages Eligible for Study:   18 Years and older   (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 is 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).

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
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United States, California
Moore UC San Diego Cancer Center /ID# 5566
La Jolla, California, United States, 92093
United States, Massachusetts
Dana-Farber Cancer Institute /ID# 5547
Boston, Massachusetts, United States, 02215
United States, Nebraska
Univ Nebraska Med Ctr /ID# 12261
Omaha, Nebraska, United States, 68198
United States, New York
North Shore University Hospital /ID# 12267
New Hyde Park, New York, United States, 11040
United States, Texas
University of Texas MD Anderson Cancer Center /ID# 5575
Houston, Texas, United States, 77030
United States, Washington
Northwest Medical Specialties /ID# 26428
Tacoma, Washington, United States, 98405
Australia, Victoria
Peter MacCallum Cancer Ctr /ID# 6583
Melbourne, Victoria, Australia, 3000
Royal Melbourne Hospital /ID# 5576
Parkville, Victoria, Australia, 3050
Germany
Uniklinik Koln /ID# 5924
Köln, Nordrhein-Westfalen, Germany, 50937
United Kingdom
Leicester Royal Infirmary /ID# 15081
Leicester, England, United Kingdom, LE1 5WW
Sponsors and Collaborators
AbbVie
Genentech, Inc.
Investigators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT00481091    
Other Study ID Numbers: M06-873
2007-002143-25 ( EudraCT Number )
First Posted: June 1, 2007    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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
Keywords provided by AbbVie:
Chronic Lymphocytic Leukemia (CLL)
Navitoclax
ABT-263
Cancer
Additional relevant MeSH terms:
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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