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SAR103168

Phase 1

Acute Myelogenous Leukemia | Small molecule | Oncology |Sanofi|Last Updated: Mar 27, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

SAR103168 · 1 trial · 1 indication

Phase 1 1
NCT00981240Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic SyndromesAcute Myelogenous Leukemia
COMPLETED30 Analytics
PHASE1COMPLETED
Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes
Acute Myelogenous Leukemia
NCT0098124030
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Study Endpoints

Primary Endpoints

Incidence of DLTs during the initial 4-week period of treatment
4 weeks
Pharmacokinetic parameters of SAR103168
First course: Days 1, 2, 5, 6, and 8; Second and subsequent courses: Day 5 only

Secondary Endpoints

Global safety profile of SAR103168 based on treatment emergent adverse events (TEAEs), serious adverse events (SAEs), deaths, laboratory abnormalities
Treatment period up to 1 year
Preliminary evidence of anti-leukemia activity
Treatment period up to 1 year
Pharmacokinetic parameters of midazolam in the absence and the presence of SAR103168.
During second (Day-1 and Day 5) and forth course (Day 5)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose escalationEXPERIMENTALCohorts 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.

Interventions

NameTypeDescription
SAR103168DRUGPharmaceutical form: Concentrate for solution for infusion Route of administration: Intravenous infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patients with refractory/relapsed acute leukemias or high-risk myelodysplastic syndromes with no curative option available including any of the following: * Patients with de novo or secondary acute myelogenous leukemia (AML) (except acute promyelocytic leukemia), meeting on...

Countries:United States
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Frequently asked questions about SAR103168

What is SAR103168 used for?

SAR103168 is an investigational small molecule being studied for the treatment of Acute Myelogenous Leukemia (AML). It was evaluated in a Phase 1 clinical trial in patients with refractory or relapsed acute leukemias or high-risk myelodysplastic syndromes. The drug is not approved and remains in clinical development.

Who makes SAR103168?

SAR103168 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi conducted a Phase 1 clinical trial of SAR103168 in the United States for the treatment of Acute Myelogenous Leukemia.

What phase is SAR103168 in?

SAR103168 is in Phase 1 clinical development. A Phase 1 dose escalation, safety and pharmacokinetic study of SAR103168 in patients with refractory or relapsed acute leukemias or high-risk myelodysplastic syndromes has been completed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is SAR103168 in?

SAR103168 has been studied in one clinical trial, identified as NCT00981240. This was a Phase 1, dose escalation, safety and pharmacokinetic study in patients with refractory or relapsed acute leukemias or high-risk myelodysplastic syndromes. The trial enrolled 30 participants and was conducted in the United States. It has been completed.

Is SAR103168 FDA approved?

SAR103168 is not FDA approved. It is an investigational drug that has been studied in a Phase 1 clinical trial for Acute Myelogenous Leukemia. The trial, NCT00981240, was completed, but the drug remains in clinical development and has not received regulatory approval.