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Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes

NCT00981240 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-03-27

No results posted yet for this 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

  • Acute Myelogenous Leukemia

Interventions

DRUG

SAR103168

Pharmaceutical form: Concentrate for solution for infusion Route of administration: Intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • Farhad Ravandi-Kashani, MD · M.D. Anderson Cancer Center, Houston, Texas

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-01-31
Completion
2012-02-29

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00981240 on ClinicalTrials.gov