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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

Tracking Information
First Submitted Date  ICMJE May 30, 2007
First Posted Date  ICMJE June 1, 2007
Last Update Posted Date December 22, 2020
Actual Study Start Date  ICMJE July 25, 2007
Estimated Primary Completion Date July 8, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • Maximum Observed Plasma Concentration (Cmax) of Navitoclax (Phase 1) [ Time Frame: Up to Day 14 ]
    Cmax of navitoclax.
  • Time to Maximum Observed Plasma Concentration (Tmax) of Navitoclax (Phase 1) [ Time Frame: Up to Day 14 ]
    Tmax of navitoclax.
  • Terminal phase elimination rate constant (β) for Navitoclax (Phase 1) [ Time Frame: Day 1 ]
    Terminal phase elimination rate constant (β) for navitoclax.
  • Terminal phase elimination half-life (t1/2) of Navitoclax (Phase 1) [ Time Frame: Day 1 ]
    Terminal phase elimination half-life (t1/2) of navitoclax.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 30, 2007)
  • Safety assessment [ Time Frame: One year ]
  • Dose limiting toxicity determination
  • Maximum tolerated dose determination
  • Pharmacokinetic profile evaluation
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2007)
  • Extended safety assessment at the recommended Phase 2 dose [ Time Frame: One year ]
  • Preliminary efficacy assessment [ Time Frame: Every two months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
Official Title  ICMJE A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Lymphocytic Leukemia
Intervention  ICMJE Drug: ABT-263
Tablet; Oral
Other Name: Navitoclax
Study Arms  ICMJE
  • 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.
    Intervention: Drug: ABT-263
  • 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.
    Intervention: Drug: ABT-263
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 5, 2020)
60
Original Estimated Enrollment  ICMJE
 (submitted: May 30, 2007)
68
Estimated Study Completion Date  ICMJE July 8, 2022
Estimated Primary Completion Date July 8, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Germany,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00481091
Other Study ID Numbers  ICMJE M06-873
2007-002143-25 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP