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NCT00543972 · ClinicalTrials.gov registry record · Phase 1

Dose Escalation Safety and Pharmacokinetic Study of AVE9633 as Single Agent in Relapsed/Refractory CD33-Positive Acute Myeloid Leukemia

A Phase 1 study, sponsored by Sanofi.

Terminated
Registry status
Phase 1
Development phase
12
Enrollment target

NCT00543972 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 12 participants.

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The verdict

NCT00543972, a Phase 1 study, was terminated before completion, sponsored by Sanofi.

TERMINATED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

The primary objective is to determine the maximum tolerated dose of AVE9633 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-leukemia activity, the global safety and the PK profile.

Interventions

  • DRUG AVE9633

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2007-09
Est. Completion 2008-08
Phase Phase 1

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00543972

The ClinicalTrials.gov registry entry for NCT00543972 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which AVE9633 is the first listed.

NCT00543972 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00543972 about?

NCT00543972 is a clinical study titled "Dose Escalation Safety and Pharmacokinetic Study of AVE9633 as Single Agent in Relapsed/Refractory CD33-Positive Acute Myeloid Leukemia". The primary objective is to determine the maximum tolerated dose of AVE9633 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-leukemia activity, the global safety and the PK profile.

What is the current status of trial NCT00543972?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2007-09. Estimated completion is 2008-08.

What interventions are being tested in trial NCT00543972?

The interventions under investigation include: AVE9633 (DRUG).

Who is sponsoring clinical trial NCT00543972?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

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

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.