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Cohorts of 3 to 6 patients will be included at each dose level. The starting dose is 1.2mg/m2/day. The dose will be increased in new cohorts of patients according to toxicities observed during the first 4-week treatment period. The escalation process will continue until the MTD is determined. Additional 15 patients will be included at the MTD.

Pharmaceutical form: Concentrate for solution for infusion

Route of administration: Intravenous infusion

SAR103168

Farhad Ravandi-Kashani, MD

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

Patients will receive the study drug until unacceptable toxicity, clinically significant disease progression, withdrawal of consent or investigator's decision, and for a maximum of 1 year.

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

A Dose Escalation Safety and Pharmacokinetic Study of SAR103168 Administered as a Single Agent by Intravenous Infusion, Once Daily for 5 Consecutive Days to Patients With Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes.

Sanofi

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes	NCT00981240	Acute Myelogeno...	SAR103168	18 Years -	Sanofi
Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes	NCT00981240	Acute Myelogeno...	SAR103168	18 Years -	Sanofi
Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes	NCT00981240	Acute Myelogeno...	SAR103168	18 Years -	Sanofi

Spots Global Cancer Trial Database for sar103168

Every month we try and update this database with for sar103168 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sar103168

Every month we try and update this database with for sar103168 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sar103168 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.