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

The duration of the study for an individual patient will include a period to assess eligibility of up to 4 weeks, a treatment period of at least 6 weeks of study treatment, and an end-of-study visit at least 30 days (or until the patient receives another anti-cancer therapy, whichever is shorter) following the last administration of study drug.

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.