A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients with Advanced Cancer. - TED12318

Sanofi-aventis0 个研究点目标入组 57 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•* Histologically or cytologically confirmed diagnosis of a solid tumor for which no further effective standard treatment is available.
•* Patients with lymphomas may be enrolled.
•* For dose escalation, tumor type that has high biomarker prevalence without molecular confirmation of biomarker status, or any tumor type with molecular confirmation of biomarker status. At a specified dose level, enrollment will be limited to dedifferenitated liposarcoma, and for the MTD cohort, only dedifferentiated liposarcoma will be included.
•* Presence of locally advanced or metastatic disease with at least one measurable lesion.

•* Age > 18 years.
•*Eastern Cooperative Oncology Group (ECOG)performance status of >1.
•*Life expectancy <12 weeks.
•*Unstable brain or leptomeningeal disease based on history and physical examination.
•* Inadequate organ functions, positive pregancy test
•* Pregnancy or breast-feeding.
•*Any anti-cancer drug therapy within 2 weeks (8 weeks for mitomycin C or nitrosoureas) prior to study treatment or 5 halflives of the drug prior to study treatment, whichever is shorter, prior to study treatment.;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 (3 months) history of acute pancreatitis

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