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SAR125844

Phase 2

Neoplasm Malignant | Small molecule | Oncology |Sanofi|Trials Updated: Apr 13, 2016

SAR125844 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Jul 2011

SAR125844 target and mechanism

Molecular targetMET
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials3
Total Enrollment143

FDA Designations

No designations recorded

SAR125844 clinical trials

SAR125844 · 3 trials · 2 indications

Phase 2 1Phase 1 2
NCT02435121A Study Assessing Efficacy and Safety of SAR125844 in NSCLC Patients With MET AmplificationNeoplasm Malignant
COMPLETED1 Analytics
PHASE2COMPLETED
A Study Assessing Efficacy and Safety of SAR125844 in NSCLC Patients With MET Amplification
Neoplasm MalignantUnlock trial analytics

Study Endpoints

Primary Endpoints

Determination of the objective response rate of SAR125844 as per RECIST 1.1
every 6 weeks up to 34 months
- DOSE ESCALATION To determine the maximum tolerated dose (MTD) of SAR125844
At d28 of Cycle 1 of each treated patient, DLT is assessed
- EXPANSION Cohort To evaluate the preliminary anti-tumoral effect of SAR125844
Antitumor activity is assessed at the end of Cycle 1, then every 2 cycles up to treatment discontinuation
Dose Escalation To determine the maximum tolerated dose (MTD) of SAR125844
At day 28 of Cycle 1 of each treated patient, DLT is assessed
Expansion Cohorts To evaluate the preliminary anti-tumoral effect of SAR125844
Anticancer activity is assessed at Day 28 and then every 8 weeks thereafter up to an expected maximum of 2 years

Secondary Endpoints

Progression-free survival rate
up to 34 months
Overall survival rate
up to 34 months
Proportion of patients with adverse events
up to 40 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAR125844EXPERIMENTALGiven intravenously weekly at the dose of 570 mg/m\^2 for at least 18 weeks
Dose escalationEXPERIMENTALSAR125844 will be administered as weekly IV infusion. Four weekly administrations are considered as 1 cycle. The starting dose will be either 1 dose level (DL) below the highest cleared dose level in a European TED11449 ongoing study or DL4 (260 mg/m\^2), if the highest cleared dose in TED11449 is \>340 mg/m\^2.

Interventions

NameTypeDescription
SAR125844DRUGPharmaceutical form:Concentrate for solution Route of administration: intravenous
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: Metastatic non-small-cell lung cancer patients with progressive disease during or after first or second line therapy harboring MET gene amplification and with measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Exclusion criteria: Patient less than...

Countries:BelgiumJapanSouth KoreaUnited StatesFranceItalySpain
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Frequently asked questions about SAR125844

What is SAR125844 used for?

SAR125844 is an investigational small molecule developed by Sanofi for the treatment of malignant solid tumors and neoplasm malignant. It has been studied in adult patients with advanced solid tumors and in non-small cell lung cancer (NSCLC) with MET amplification. It is not approved for any indication.

What does SAR125844 target?

SAR125844 targets MET, a receptor tyrosine kinase. It acts as an inhibitor of MET. This targeted approach is designed to interfere with MET signaling, which can drive tumor growth and survival in cancers with MET alterations.

Who is developing SAR125844?

SAR125844 is being developed by Sanofi, a global pharmaceutical company. Sanofi's ticker symbol is SNY. The drug is part of Sanofi's oncology pipeline.

What phase is SAR125844 in?

SAR125844 has been studied in Phase 1 and Phase 2 clinical trials. The Phase 1 trials are completed, and a Phase 2 trial in NSCLC with MET amplification is also completed. The drug remains investigational and has not been approved by the FDA.

What clinical trials is SAR125844 in?

SAR125844 has been evaluated in three completed clinical trials: NCT01391533, a Phase 1 trial in advanced solid tumors; NCT01657214, a Phase 1 dose escalation trial in Asian patients with solid tumors; and NCT02435121, a Phase 2 trial in NSCLC patients with MET amplification.