A Safety and Efficacy Study of SAR405838 and Pimasertib in Cancer Patients

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:

* Age \<18 years.
* Eastern Cooperative Oncology Group performance status of \>1.
* Inadequate functions of bone marrow, liver, and kidney.
* Positive pregnancy test in women of child-bearing potential.
* Pregnancy or breast-feeding.
* Extensive prior radiotherapy.
* The patient has retinal degenerative disease, history of uveitis, or history of retinal vein occlusion, or history of retinal detachment, or has medically relevant abnormalities identified on screening ophthalmologic examination.
* Prior history of myositis or rhabdomyolysis.
* Recent major surgery or trauma, unhealing/open wounds.
* The patient has had congestive heart failure, unstable angina, a myocardial infarction, cardiac conduction abnormality or pacemaker or a stroke within 3 months of entering the study.
* The patient has a baseline corrected QT interval (QTc) \>480 ms or left ventricular ejection fraction (LVEF) \<50% or less than the lower limit of normal.
* The patient has a previously-identified allergy or hypersensitivity to components of the study treatment formulations.
* Unwillingness or inability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
* Unwillingness, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ an effective barrier or medical method of contraception during the study drug administration and follow-up periods.
* Recent history of acute pancreatitis.
* Clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that could affect the safety of the patient; alter the absorption of the study drugs; or impair the assessment of study results.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.