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NCT00587457 · ClinicalTrials.gov registry record · Phase 1
A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Participants With Chronic Leukemia
A Phase 1 study, sponsored by MedImmune.
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT00587457: Clinical Trial Phase 1 study, sponsored by MedImmune.
NCT00587457 is a Phase 1 study that was terminated before completion, run by MedImmune. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00587457, a Phase 1 study, was terminated before completion, sponsored by MedImmune.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This was a multicenter, Phase 1, standard 3+3 dose-escalation study to evaluate the safety and anti-neoplastic activity of moxetumomab pasudotox in relapsed or refractory participants with chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL) or Small Lymphocytic Lymphoma (SLL).
Primary Outcome
An adverse event (AE) events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of
Interventions
- DRUG CAT-8015 20 mcg/kg
- DRUG CAT-8015 5 mcg/kg
- DRUG CAT-8015 10 mcg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2007-03-07 |
| Est. Completion | 2008-04-07 |
| Phase | Phase 1 |
Why NCT00587457 stopped before completion
NCT00587457 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 3 interventions - of which CAT-8015 20 mcg/kg is the first listed.
NCT00587457 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00587457 about?
NCT00587457 is a clinical study titled "A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Participants With Chronic Leukemia". This was a multicenter, Phase 1, standard 3+3 dose-escalation study to evaluate the safety and anti-neoplastic activity of moxetumomab pasudotox in relapsed or refractory participants with chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL) or Small Lymphocytic Lymphoma (SLL).
What is the current status of trial NCT00587457?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2007-03-07. Estimated completion is 2008-04-07.
What interventions are being tested in trial NCT00587457?
The interventions under investigation include: CAT-8015 20 mcg/kg (DRUG), CAT-8015 5 mcg/kg (DRUG), CAT-8015 10 mcg/kg (DRUG).
Who is sponsoring clinical trial NCT00587457?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00587457's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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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