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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 is a Phase 1 study that has completed, run by AbbVie (prior sponsor, Abbott). The registered enrollment target is 81 participants.

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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).

Interventions

  • DRUG ABT-263

Trial Details

FieldValue
Enrollment Target 81 participants
Start Date 2006-11
Est. Completion 2016-10
Phase Phase 1

Sponsor

AbbVie (prior sponsor, Abbott)

88 total trials

What the Registry Record Tells You About NCT00406809

The ClinicalTrials.gov registry entry for NCT00406809 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie (prior sponsor, Abbott), which has 88 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which ABT-263 is the first listed.

NCT00406809 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.