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SAR405838

Phase 1

Neoplasm Malignant | Small molecule | Oncology |Sanofi|Last Updated: May 17, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment103

FDA Designations

No designations recorded

Clinical trial landscape

SAR405838 · 2 trials · 1 indication

Phase 1 2
NCT01985191A Safety and Efficacy Study of SAR405838 and Pimasertib in Cancer PatientsNeoplasm Malignant
COMPLETED26 Analytics
NCT01636479Phase 1 Safety Testing of SAR405838Neoplasm Malignant
COMPLETED77 Analytics
PHASE1COMPLETED
A Safety and Efficacy Study of SAR405838 and Pimasertib in Cancer Patients
Neoplasm MalignantUnlock trial analytics
PHASE1COMPLETED
Phase 1 Safety Testing of SAR405838
Neoplasm MalignantUnlock trial analytics

Study Endpoints

Primary Endpoints

SAR405838 (pimasertib) RP2D assessed by dose-limiting toxicities and pharmacological activities
6 weeks for each patient at each dose level
Changes of tumor dimension by imaging
At least 3 months for each patient
SAR405838 Maximum tolerated dose (MTD)
Cycle 1 (21 days) or 2 Cycles (42 days) dependent on dosing schedule
In MTD cohort, clinical benefit
Until disease progression

Secondary Endpoints

Overall safety profile of SAR405838 (pimasertib), number of participants with adverse events
Throughout the study
Pharmacokinetic parameters for both SAR405838 (pimasertib): the maximum concentration in blood (Cmax)
3 months for each patient
Pharmacokinetic parameters for both SAR405838 (pimasertib): time to the maximum concentration (Tmax)
3 months for each patient
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTALSAR405838 and pimasertib in escalating doses
SAR405838EXPERIMENTALSAR405838 in escalating doses

Interventions

NameTypeDescription
SAR405838DRUGPharmaceutical form:capsule Route of administration: oral
PimasertibDRUGPharmaceutical form: capsule Route of administration: oral
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion criteria: * Histologically or cytologically confirmed diagnosis of a solid tumor. * Presence of locally advanced or metastatic disease with at least one measurable lesion. * Ability to provide written informed consent. Evidence of a personally signed informed consent. Exclusion criteria:...

Countries:FranceNetherlandsUnited States
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Frequently asked questions about SAR405838

What is SAR405838 used for?

SAR405838 is an investigational small molecule being studied for the treatment of Neoplasm Malignant, a term for malignant tumors or cancer. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes SAR405838?

SAR405838 is being developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker symbol SNY. The drug is currently in Phase 1 clinical trials for oncology indications.

What phase is SAR405838 in?

SAR405838 is in Phase 1 clinical development. It has completed two Phase 1 trials, and it remains an investigational drug that has not received regulatory approval. Its safety and efficacy are still being evaluated in clinical studies.

What clinical trials is SAR405838 in?

SAR405838 has been studied in two completed Phase 1 trials. The first, NCT01636479, tested the safety of SAR405838 alone in 77 patients. The second, NCT01985191, evaluated SAR405838 combined with pimasertib in 26 cancer patients. Both trials enrolled adults with malignant neoplasms.

Is SAR405838 the same as pimasertib?

No, SAR405838 is not the same as pimasertib. They are distinct investigational drugs that have been studied together in a combination trial (NCT01985191). SAR405838 is a small molecule developed by Sanofi, while pimasertib is a separate agent used in the combination study.