advanced cancer
Conditions
Interventions
SAR405838 will be taken at various doses orally once daily. Pimasertib will be
taken at various doses orally twice daily.
Sponsors
Sanofi-aventis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Histologically or cytologically confirmed diagnosis of a solid tumor; Presence of locally advanced or metastatic disease with at least one measurable lesion that is not responsive to standard therapies or for which no approved or curative therapy is available. Ability to provide written informed consent. Evidence of a personally signed informed consent;
Exclusion criteria
Exclusion criteria: Age 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * SAR405838 / pimasertib MTD (Maximum Tolerated Dose) and RP2D (Recommended Phase 2 Dose) as assessed by DLT (dose-limiting toxicity) and the biological acitivities within the tested dose range. * In RP2D cohort expansion, tumor response and duration, as defined by RECIST 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Overall safety profile of SAR405838 / Pimasertib (adverse events) * PK parameters (Cmax, Tmax, AUC) * PD biomarkers (MIC-1, IL-8, pERK, PBMC) * In dose escalation phase, tumor response and duration. * Genetic status of TP53/Ras in tumor tissue and ctDNA at baseline and post study drug treatment | — |
Countries
Netherlands
Outcome results
None listed