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NCT00481091 · ClinicalTrials.gov registry record · Phase 1
A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
A Phase 1 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT00481091: Completed Phase 1 study, sponsored by AbbVie.
NCT00481091 is a Phase 1 study that has completed, run by AbbVie. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00481091, a Phase 1 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
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-threaten
Interventions
- DRUG ABT-263
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2007-07-25 |
| Est. Completion | 2022-05-12 |
| Phase | Phase 1 |
What the finished NCT00481091 record still lists
NCT00481091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which ABT-263 is the first listed.
NCT00481091 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00481091 about?
NCT00481091 is a clinical study titled "A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia". 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 recommend...
What is the current status of trial NCT00481091?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2007-07-25. Estimated completion is 2022-05-12.
What interventions are being tested in trial NCT00481091?
The interventions under investigation include: ABT-263 (DRUG).
Who is sponsoring clinical trial NCT00481091?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00481091's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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