A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
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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
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Condition or disease | Intervention/treatment | Phase |
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Chronic Lymphocytic Leukemia | Drug: ABT-263 | Phase 1 Phase 2 |
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 |

Arm | Intervention/treatment |
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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.
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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.
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Drug: ABT-263
Tablet; Oral
Other Name: Navitoclax |
- 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.

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 and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

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
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 |
Study Director: | AbbVie Inc. | AbbVie |
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 |
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 |
Chronic Lymphocytic Leukemia (CLL) Navitoclax ABT-263 Cancer |
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 |