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NCT00406809 · ClinicalTrials.gov registry record · Phase 1
A Study of ABT-263 in Subjects With Relapsed or Refractory Lymphoid Malignancies
A Phase 1 study, sponsored by AbbVie (prior sponsor, Abbott).
- Completed
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
NCT00406809: Completed Phase 1 study, sponsored by AbbVie (prior sponsor, Abbott).
NCT00406809 is a Phase 1 study that has completed, run by AbbVie (prior sponsor, Abbott). The registered enrollment target is 81 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00406809, a Phase 1 study, has completed, sponsored by AbbVie (prior sponsor, Abbott).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
Study Summary
The Phase 1 portion of the study evaluated the pharmacokinetic profile and safety of ABT-263 with the objective of defining the dose limiting toxicity and maximum tolerated dose in subjects with lymphoid malignancies. The Phase 2a portion of the study is evaluating ABT-263 using a step-up dosing regimen and may be increased to the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy in subject with lymphoid malignancies. The Extension portion of the study is to allow Phase 2a subjects who remain active 1 year after the last subject enrolls or who have been on study approximately 1 year to continue receiving ABT-263 with less frequent study evaluations. Subjects in the Extension Study will continue receiving study drug for up to 7 years after the last subject transitions to the Extension Study, or until disease progression or toxicity that necessitates discontinuation (whichever comes first).
Primary Outcome
1a: Determination of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) under a 14/21 day dosing schedule
Interventions
- DRUG ABT-263
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2006-11 |
| Est. Completion | 2016-10 |
| Phase | Phase 1 |
What the finished NCT00406809 record still lists
NCT00406809 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 1 intervention - of which ABT-263 is the first listed.
NCT00406809 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00406809 about?
NCT00406809 is a clinical study titled "A Study of ABT-263 in Subjects With Relapsed or Refractory Lymphoid Malignancies". The Phase 1 portion of the study evaluated the pharmacokinetic profile and safety of ABT-263 with the objective of defining the dose limiting toxicity and maximum tolerated dose in subjects with lymphoid malignancies. The Phase 2a portion of the study is evaluating ABT-263 using a step-up dosing reg...
What is the current status of trial NCT00406809?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2006-11. Estimated completion is 2016-10.
What interventions are being tested in trial NCT00406809?
The interventions under investigation include: ABT-263 (DRUG).
Who is sponsoring clinical trial NCT00406809?
This trial is sponsored by AbbVie (prior sponsor, Abbott), which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00406809's enrollment target sits among peer trials
81 671st of 2000 higher than 1,329 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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