Trial · NCT00481091
A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
NCT00481091, Phase 1, Phase 2, Completed, AbbVie; results first posted 2023-06-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia. Trials, record NCT00481091. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00481091
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
- NCT number
- NCT00481091
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- ABT-263
- First posted
- 2007-06-01
- Last updated
- 2023-06-13
- Other registries' IDs
- eudract:2007-002143-25
- Results first posted
- 2023-06-13
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) | From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. | An 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. An SAE is one that: results in death, hospitalization, prolongation of hospitalization, or persistent or significant disability/incapacity; is life-threatening, a congenital anomaly, or other important medical event. Events were graded as 1=mild, 2=moderate, 3=severe, 4=life-threatening, or 5=death. 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. A treatment-emergent adverse event is defined as any adverse event with onset or worsening reported by a subject from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug administration. Deaths category included non treatment emergent deaths. |
| Primary | Phase 1: Number of Participants With DLTs in the Dose Escalation Phase | Cycle 1 (Up to 21 days) plus 7 days | DLTs were graded according to NCI CTCAE version 3.0 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life threatening; grade 5=death). Any of the following events, considered possibly or probably related to the administration of navitoclax, were considered a DLT: Grade 4 thrombocytopenia (\< 25,000/mm\^3); platelet counts \< 25,000/mm\^3, Grade 2 or higher bleeding associated with thrombocytopenia; all other Grade 3, 4 or 5 adverse events were considered a DLT. Exceptions included: Grade 3, 4 febrile neutropenia less than 7 days; Grade 3, 4 leukopenia; Grade 3, 4 lymphopenia; Grade 3 nausea, vomiting and/or diarrhea unless unresponsive to treatment; Grade 2 toxicity that requires dose modification or delay of \> 1 week. |
| Primary | Phase 1: Maximum Tolerated Dose (MTD) in the Dose Escalation Phase | Cycle 1 (Up to 21 days) plus 7 days | The MTD was defined as the dose at which 30% of participants experienced a DLT during the first cycle. DLTs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life threatening; grade 5=death). Any of the following events, considered possibly or probably related to the administration of navitoclax, were considered a DLT: Grade 4 thrombocytopenia (\< 25,000/mm\^3); platelet counts \< 25,000/mm\^3, Grade 2 or higher bleeding associated with thrombocytopenia; all other Grade 3, 4 or 5 adverse events were considered a DLT. Exceptions included: Grade 3, 4 febrile neutropenia less than 7 days; Grade 3, 4 leukopenia; Grade 3, 4 lymphopenia; Grade 3 nausea, vomiting and/or diarrhea unless unresponsive to treatment; Grade 2 toxicity that requires dose modification or delay of \> 1 week. |
| Primary | Phase 1: Recommended Phase 2 Dose (RPTD) Determined in the Dose Escalation Phase | Cycle 1 (Up to 21 days) plus 7 days | The RPTD was determined based on observed DLTs and/or determination of the MTD in phase 1. (See Outcome Measures 2 and 3 above for definition of DLT and MTD.) |
| Primary | Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Navitoclax | Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose | |
| Primary | Phase 1: Maximum Observed Plasma Concentration (Cmax) | Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose | |
| Primary | Phase 1: Area Under the Plasma Concentration-Time Curve From Time 0 to Hour 8 (AUC8) | Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose | |
| Primary | Phase 1: Area Under the Plasma Concentration-Time Curve From Time 0 to Hour 24 (AUC24) | Cycle 1 Day 1: pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Cycle 1 Days 14: pre-dose, 2, 4, 6, 8 | The AUC24 was derived and reported from Cycle 1 Day 1 values and Cycle 1 Day 14 values; the pre-dose value taken on Day 14 was utilized as 24-hour timepoint on Day 14 to generate AUC24 for Day 14. |
| Primary | Phase 1: Cmax/Dose | Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose | |
| Primary | Phase 1: AUC8/Dose | Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) | From first dose of study drug to 30 days post-last dose. Participants enrolled in the 14/21-day cycle received a mean of 21.7 treatment cycles; participants enrolled in the 21/21-day cycle received a mean of 19.4 treatment cycles. | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Phase 1: Number of Participants With DLTs in the Dose Escalation Phase | Cycle 1 (Up to 21 days) plus 7 days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Phase 1: Maximum Tolerated Dose (MTD) in the Dose Escalation Phase | Cycle 1 (Up to 21 days) plus 7 days | mg | NUMBER | |
| PRIMARY | Phase 1: Recommended Phase 2 Dose (RPTD) Determined in the Dose Escalation Phase | Cycle 1 (Up to 21 days) plus 7 days | mg | NUMBER | |
| PRIMARY | Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Navitoclax | Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose | Participants with an assessment at given time point. One participant in the Navitoclax 14/21 Day Cycle: 250 mg arm dose-reduced to 200 mg on Days 4 to14, and therefore was analyzed in the Navitoclax 14/21 Day Cycle: 200 mg arm for Cycle 1 Day 14. | hours | MEAN |
| PRIMARY | Phase 1: Maximum Observed Plasma Concentration (Cmax) | Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose | Participants with an assessment at given time point. One participant in the Navitoclax 14/21 Day Cycle: 250 mg arm dose-reduced to 200 mg on Days 4 to14, and therefore was analyzed in the Navitoclax 14/21 Day Cycle: 200 mg arm for Cycle 1 Day 14. | μg/mL | MEAN |
| PRIMARY | Phase 1: Area Under the Plasma Concentration-Time Curve From Time 0 to Hour 8 (AUC8) | Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose | Participants with an assessment at given time point. One participant in the Navitoclax 14/21 Day Cycle: 250 mg arm dose-reduced to 200 mg on Days 4 to14, and therefore was analyzed in the Navitoclax 14/21 Day Cycle: 200 mg arm for Cycle 1 Day 14. | μg•hr/mL | MEAN |
| PRIMARY | Phase 1: Area Under the Plasma Concentration-Time Curve From Time 0 to Hour 24 (AUC24) | Cycle 1 Day 1: pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Cycle 1 Days 14: pre-dose, 2, 4, 6, 8 | Participants with an assessment at given time point. One participant in the Navitoclax 14/21 Day Cycle: 250 mg arm dose-reduced to 200 mg on Days 4 to14, and therefore was analyzed in the Navitoclax 14/21 Day Cycle: 200 mg arm for Cycle 1 Day 14. | μg•hr/mL | MEAN |
| PRIMARY | Phase 1: Cmax/Dose | Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose | Participants with an assessment at given time point. One participant in the Navitoclax 14/21 Day Cycle: 250 mg arm dose-reduced to 200 mg on Days 4 to14, and therefore was analyzed in the Navitoclax 14/21 Day Cycle: 200 mg arm for Cycle 1 Day 14. | ng/mL/mg | MEAN |
| PRIMARY | Phase 1: AUC8/Dose | Cycle 1 Days 1 and 14: pre-dose, 2, 4, 6, 8 hours post-dose | Participants with an assessment at given time point. One participant in the Navitoclax 14/21 Day Cycle: 250 mg arm dose-reduced to 200 mg on Days 4 to14, and therefore was analyzed in the Navitoclax 14/21 Day Cycle: 200 mg arm for Cycle 1 Day 14. | ng•hr/mL/mg | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group264
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) | Navitoclax 14/21 Day Cycle: 10 mg | Any AE | 3 | Participants | |
| Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) | Navitoclax 14/21 Day Cycle: 110 mg | Any AE | 6 | Participants | |
| Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) | Navitoclax 14/21 Day Cycle: 200 mg | Any AE | 3 | Participants | |
| Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) | Navitoclax 14/21 Day Cycle: 250 mg | Any AE | 3 | Participants | |
| Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) | Navitoclax 21/21 Day Cycle: 125 mg | Any AE | 3 | Participants | |
| Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) | Navitoclax 21/21 Day Cycle: 200 mg | Any AE | 4 | Participants | |
| Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) | Navitoclax 21/21 Day Cycle: 250 mg | Any AE | 3 | Participants | |
| Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) | Navitoclax 21/21 Day Cycle: 300 mg | Any AE | 4 | Participants | |
| Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) | Navitoclax 14/21 Day Cycle: 10 mg | Any AE at least possibly related to navitoclax | 3 | Participants | |
| Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) | Navitoclax 14/21 Day Cycle: 110 mg | Any AE at least possibly related to navitoclax | 4 | Participants |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Navitoclax 14/21 Day Cycle: 10 mg | 3 | |
| Overall Study | STARTED | Navitoclax 14/21 Day Cycle: 110 mg | 6 | |
| Overall Study | STARTED | Navitoclax 14/21 Day Cycle: 200 mg | 3 | |
| Overall Study | STARTED | Navitoclax 14/21 Day Cycle: 250 mg | 3 | |
| Overall Study | STARTED | Navitoclax 21/21 Day Cycle: 125 mg | 3 | |
| Overall Study | STARTED | Navitoclax 21/21 Day Cycle: 200 mg | 4 | |
| Overall Study | STARTED | Navitoclax 21/21 Day Cycle: 250 mg | 3 | |
| Overall Study | STARTED | Navitoclax 21/21 Day Cycle: 300 mg | 4 | |
| Overall Study | STARTED | Phase 2: Navitoclax 100 mg | 4 | |
| Overall Study | STARTED | Phase 2: Navitoclax 250 mg | 27 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events2,600
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Navitoclax 14/21 Day Cycle: 10 mg | 0 | 3 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Navitoclax 14/21 Day Cycle: 110 mg | 1 | 6 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | Navitoclax 14/21 Day Cycle: 200 mg | 0 | 3 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Navitoclax 14/21 Day Cycle: 250 mg | 0 | 3 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Navitoclax 21/21 Day Cycle: 125 mg | 0 | 3 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Navitoclax 21/21 Day Cycle: 200 mg | 0 | 4 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Navitoclax 21/21 Day Cycle: 250 mg | 0 | 3 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Navitoclax 21/21 Day Cycle: 300 mg | 1 | 4 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | Phase 2: Navitoclax 100 mg | 0 | 4 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Phase 2: Navitoclax 250 mg | 4 | 27 | 7 |
1 to 10 of 2,600Source ClinicalTrials.gov
See all 2,600 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Navitoclax 14/21 Day Cycle: 10 mg | 0 | 3 |
| Total, all-cause mortality | Navitoclax 14/21 Day Cycle: 110 mg | 1 | 6 |
| Total, all-cause mortality | Navitoclax 14/21 Day Cycle: 200 mg | 0 | 3 |
| Total, all-cause mortality | Navitoclax 14/21 Day Cycle: 250 mg | 0 | 3 |
| Total, all-cause mortality | Navitoclax 21/21 Day Cycle: 125 mg | 1 | 3 |
| Total, all-cause mortality | Navitoclax 21/21 Day Cycle: 200 mg | 0 | 4 |
| Total, all-cause mortality | Navitoclax 21/21 Day Cycle: 250 mg | 0 | 3 |
| Total, all-cause mortality | Navitoclax 21/21 Day Cycle: 300 mg | 0 | 4 |
| Total, all-cause mortality | Phase 2: Navitoclax 100 mg | 1 | 4 |
| Total, all-cause mortality | Phase 2: Navitoclax 250 mg | 8 | 27 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22184378 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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