A Phase Ib/II, open-label, multi-center, dose-finding study to assess the safety and efficacy of the oral combination of LDE225 and INC424 (Ruxolitinib) in patients with myelofibrosis

ovartis Pharma Services AG0 个研究点目标入组 82 人开始时间: 2014年4月9日最近更新: 2018年4月30日

适应症

试验速览

暂无简介。

•- Diagnosed with PMF per 2008 WHO criteria, post-PV MF or post-ET MF per IWG-MRT criteria.
•- Ineligible or unwilling to undergo stem cell transplantion.
•- PLT counts > or = 75X 10^9/L not reached with the aid of transfusions.
•- ECOG performance status = 2.
•- Palpable splenomegaly defined as = 5 cm below the left costal margin.
•- Intermediate risk level 1 (1 prognostic factor which is not age), Intermediate risk level 2, or high risk.
•- Active symptoms of MF.
•Other protocol defined inclusion criteria may apply.
•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 41
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 41

•-Previous therapy with JAK or Smoothened inhibitors.
•- Patient is currently on medications that interfere with coagulation
•(including warfarin) or platelet function. Low dose aspirin (up to 150 mg
•per day) and LMWH are allowed.
•- Impairment of GI function or GI disease that may significantly alter the absorption of INC424 or LDE225 (e.g., uncontrolled nausea, vomiting, diarrhea; malabsorption syndrome; small bowel resection).
•- Splenic irradiation within 12 months prior to Screening.
•- Pregnant or nursing women.
•- Women of childbearing potential not using highly effective methods of contraception
•- Sexually active males who refuse condom use
•- Patients who have neuromuscular disorders or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis.
•Other protocol defined exclusion criteria may apply.

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