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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 11, 2019
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 9 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)
Estimated Enrollment : 72 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 : September 4, 2020
Estimated Study Completion Date : September 4, 2020


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





Primary Outcome Measures :
  1. Number of Subjects with Adverse Events in the in the Dose Escalation Phase (Phase 1) [ Time Frame: From first dose of study drug to 30 days after the last dose of study drug (up to approximately 13 years) ]
    Treatment emergent adverse events defined as any adverse event from the time of study drug administration until 30 days after the last dose of study drug.

  2. Number of participants with Potentially Clinically Significant (PCS) Hematology Values in the Dose Escalation Phase (Phase 1) [ Time Frame: Up to approximately 13 years ]
    Blood samples for clinical laboratory tests will be collected throughout the study for clinical laboratory tests.

  3. Number of participants with PCS Clinical Chemistry Values in the Dose Escalation Phase (Phase 1) [ Time Frame: Up to approximately 13 years ]
    Blood samples for clinical laboratory tests will be collected throughout the study for clinical laboratory tests.

  4. Number of participants with PCS Vital Signs Values in the Dose Escalation Phase (Phase 1) [ Time Frame: Up to approximately 13 years ]
    Vital signs will be collected throughout the study for clinical laboratory tests.

  5. Number of Participants with Dose Limiting Toxicity (DLT) in the Dose Escalation Phase (Phase 1) [ Time Frame: Cycle 1 (14 days on therapy and 7 days off therapy OR 21 days continuous dosing) ]
    DLTs graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0.

  6. Maximum Tolerated Dose (MTD) in the Dose Escalation Phase (Phase 1) [ Time Frame: Cycle 1 (14 days on therapy and 7 days off therapy OR 21 days continuous dosing) ]
    The MTD will be determined by using available clinical data during dose escalation in phase 1.

  7. Recommended Phase 2 Dose (RPTD) Determined in the Dose Escalation Phase (Phase 1) [ Time Frame: Cycle 1 (14 days on therapy and 7 days off therapy OR 21 days continuous dosing) ]
    The RPTD will be determined based on observed dose-limiting toxicities (DLTs) and/or determination of the maximum tolerated dose (MTD) in phase 1.

  8. Plasma Concentrations of navitoclax on Cycle 1, Day 1 in the Dose Escalation Phase (Phase 1) [ Time Frame: Day 1 ]
    Plasma concentrations of navitoclax

  9. Plasma Concentrations of navitoclax on Cycle 1, Day 14 in the Dose Escalation Phase (Phase 1) [ Time Frame: Day 14 ]
    Plasma concentrations of navitoclax

  10. Maximum Serum Concentration (Cmax) of navitoclax on Cycle 1, Day 1 in the Dose Escalation Phase (Phase 1) [ Time Frame: Day 1 ]
    Cmax of navitoclax.

  11. Cmax of navitoclax on Cycle 1, Day 14 in the Dose Escalation Phase (Phase 1) [ Time Frame: Day 14 ]
    Cmax of navitoclax.

  12. Area Under the Plasma Concentration-time Curve over time from 0 to 24 hours (AUC0-24) of navitoclax on Cycle 1, Day 1 in the Dose Escalation Phase (Phase 1) [ Time Frame: Day 1 ]
    AUC0-24 of navitoclax.

  13. AUC0-24 of navitoclax on Cycle 1, Day 14 in the Dose Escalation Phase (Phase 1) [ Time Frame: Day 14 ]
    AUC0-24 of navitoclax.

  14. Time to Maximum Observed Plasma Concentration (Tmax) of navitoclax on Cycle 1, Day 1 in the Dose Escalation Phase (Phase 1) [ Time Frame: Day 1 ]
    Cmax of navitoclax.

  15. Tmax of navitoclax on Cycle 1, Day 14 in the Dose Escalation Phase (Phase 1) [ Time Frame: Day 14 ]
    Cmax of navitoclax.

  16. Number of Subjects with Adverse Events in the Recommended Phase 2 Dose Phase (Phase 2) [ Time Frame: From first dose of study drug to 30 days after the last dose of study drug (up to approximately 13 years) ]
    Treatment emergent adverse events defined as any adverse event from the time of study drug administration until 30 days after the last dose of study drug.

  17. Number of participants with PCS Hematology Values in the Recommended Phase 2 (RPTD) Phase (Phase 2) [ Time Frame: Up to approximately 13 years ]
    Blood samples for clinical laboratory tests will be collected throughout the study for clinical laboratory tests.

  18. Number of participants with PCS Clinical Chemistry Values in the Recommended Phase 2 Dose (RPTD) Phase (Phase 2) [ Time Frame: Up to approximately 13 years ]
    Blood samples for clinical laboratory tests will be collected throughout the study for clinical laboratory tests.

  19. Number of participants with PCS Vital Signs Values in the Recommended Phase 2 Dose (RPTD) Phase (Phase 2) [ Time Frame: Up to approximately 13 years ]
    Vital signs will be collected throughout the study for clinical laboratory tests.

  20. Plasma Concentrations of navitoclax on Cycle 1, Day 15 in the Recommended Phase 2 Dose (RPTD) Phase (Phase 2) [ Time Frame: Day 15 ]
    Plasma concentrations of navitoclax

  21. Cmax of navitoclax on Cycle 1, Day 15 in the Recommended Phase 2 Dose (RPTD) Phase (Phase 2) [ Time Frame: Day 15 ]
    Cmax of navitoclax.

  22. AUC0-24 of navitoclax on Cycle 1, Day 15 in the Recommended Phase 2 Dose (RPTD) Phase (Phase 2) [ Time Frame: Day 15 ]
    AUC0-24 of navitoclax.

  23. Tmax of navitoclax on Cycle 1, Day 15 in the Recommended Phase 2 Dose (RPTD) Phase (Phase 2) [ Time Frame: Day 15 ]
    Cmax of navitoclax.

  24. Number of Subjects with Adverse Events in the Extension Study [ Time Frame: From first dose of study drug to 30 days after the last dose of study drug (up to approximately 13 years) ]
    Treatment emergent adverse events defined as any adverse event from the time of study drug administration until 30 days after the last dose of study drug.

  25. Number of participants with PCS Hematology Values in the Extension Study [ Time Frame: Up to approximately 13 years ]
    Blood samples for clinical laboratory tests will be collected throughout the study for clinical laboratory tests.

  26. Number of participants with PCS Clinical Chemistry Values in the Extension Study [ Time Frame: Up to approximately 13 years ]
    Blood samples for clinical laboratory tests will be collected throughout the study for clinical laboratory tests.

  27. Number of participants with PCS Vital Signs Values in the Extension Study [ Time Frame: Up to approximately 13 years ]
    Vital signs will be collected throughout the study for clinical laboratory tests.

  28. Progression-free Survival (PFS) [ 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.

  29. Overall Survival (OS) [ 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 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)

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
Ucsd /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
Univ TX, MD Anderson /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

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Responsible Party: AbbVie
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 11, 2019
Last Verified: April 2019
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)
Analytic Code
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

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