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NCT00981240 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes
A Phase 1 study of Acute Myelogenous Leukemia, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 3
- Study locations
NCT00981240 is a Phase 1 study of Acute Myelogenous Leukemia that has completed, run by Sanofi. The registered enrollment target is 30 participants, below the 139-participant average among 38 other Acute Myelogenous Leukemia trials with a reported enrollment target (78% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT00981240, a Phase 1 study of Acute Myelogenous Leukemia, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 3
- Study locations
Study Summary
Primary objectives: * To determine the maximum tolerated dose (MTD) of SAR103168 and to characterize the dose limiting toxicities (DLTs) in the proposed dose regimen * To evaluate the pharmacokinetic (PK) profile of SAR103168 Secondary objectives: * To characterize the global safety profile of SAR103168 * To evaluate preliminary anti-leukemia activity * To investigate the potential induction effect on CYP3A4 and persistence of this effect by using oral midazolam as a probe substrate in patients enrolled into the expanded cohort at the MTD * To determine the metabolic pathways of SAR103168 and identify the chemical structures of metabolites * To determine the potential impact of SAR103168 on the QTc interval in patients enrolled at the MTD
Conditions Studied
Interventions
- DRUG SAR103168
Study Locations (3)
Georgia
- Sanofi-Aventis Investigational Site Number 840003 - Atlanta
New York
- Sanofi-Aventis Investigational Site Number 840002 - New York
Texas
- Sanofi-Aventis Investigational Site Number 840001 - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2009-09 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00981240
The ClinicalTrials.gov registry entry for NCT00981240 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 139-participant average among 38 other Acute Myelogenous Leukemia trials with a reported enrollment target (78% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Acute Myelogenous Leukemia appearing as the primary indexed condition, and to 1 intervention - of which SAR103168 is the first listed.
NCT00981240 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Georgia, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT00981240 about?
NCT00981240 is a clinical study titled "Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes". Primary objectives: * To determine the maximum tolerated dose (MTD) of SAR103168 and to characterize the dose limiting toxicities (DLTs) in the proposed dose regimen * To evaluate the pharmacokinetic (PK) profile of SAR103168 Secondary objectives: * To characterize the global safety profile of SA...
What is the current status of trial NCT00981240?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2009-09. Estimated completion is 2012-02.
What conditions does trial NCT00981240 study?
This clinical trial studies the following conditions: Acute Myelogenous Leukemia.
What interventions are being tested in trial NCT00981240?
The interventions under investigation include: SAR103168 (DRUG).
Who is sponsoring clinical trial NCT00981240?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00981240 being conducted?
This trial has 3 study locations across Georgia, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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