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Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes
NCT00981240 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00981240 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Georgia, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00981240?
The interventions under investigation include: SAR103168 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00981240?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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