A Phase 2 study of SAR245409 in patients with relapsed or refractory mantle cell lymphoma, follicular lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma

sanofi-aventis recherche & développement0 个研究点目标入组 138 人开始时间: 2011年6月1日最近更新: 2015年8月17日

适应症

试验速览

暂无简介。

•Tissue from an archived or fresh tumor sample
•A peripheral blood buffy coat sample is required for CLL/SLL.
•Patient has mantle cell lymphoma (MCL), follicular lymphoma (FL), or chronic lymphocytic leukemia (CLL)/SLL
•Patient > or = 18 years old
•ECOG performance status < or = 2
•Adequate white blood cells and hemoglobin
•Good kidney and liver function
•Fasting glucose < 160 mg/dL
•No other malignancy
•Use of adequate birth control
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 110
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 28

•- Treatment with cytotoxic chemotherapy, biologic agents, investigational therapies within 4 weeks, or nitrosoureas or mitomycin C within 6 weeks of study enrollment
•- Treatment with a small-molecule kinase inhibitor within 2 weeks, or 5 half lives of the drug or its active metabolites (whichever is longer) of study enrollment
•- Prior treatment with a PI3K, mTOR, or Akt inhibitor. Prior treatment of MCL with temsirolimus is permitted in patients enrolled from countries where it is licensed for this indication.
•- Radiation therapy within 2 weeks of enrollment
•- Autologous stem cell transplantation within 16 weeks of enrollment
•- Prior allogeneic transplantation
•- Central nervous system or leptomeningeal involvement
•- Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (anti-HCV) serology

发起方