EUCTR2010-022629-14-GR进行中（未招募）1 期
A phase II, randomized double-blind study of efficacy and safety of two dose levels of LDE225 in patients with locally advanced or metastatic basal cell carcinoma - BOLT
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients eligible for inclusion in this study have to meet all of the following criteria:
- •1. Age 18 years or older
- •2. Patient with locally advanced BCC or metastatic BCC
- •3. WHO performance status = 2
- •4. Patients with adequate bone marrow, liver and renal function
- •5. Written informed consent obtained prior to any screening procedures
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Patients eligible for this study must not meet any of the following criteria:
- •1. Patients who have had major surgery within 4 weeks of initiation of study medication.
- •2. Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study data.
- •3. Patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract or known malabsorption syndromes.
- •4. Patients who have previously been treated with systemic LDE225 or with other Hh pathway inhibitors.
- •5. a) Patients who have neuromuscular disorders or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis and that cannot be discontinued at least 2 weeks prior to starting LDE225 treatment.
- •b) Patients who are planning on embarking on a new strenuous exercise regimen after initiation of study treatment. NB: Muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided whilst on LDE225 treatment.
- •6. Patients who have taken part in an experimental drug study within 4 weeks of initiating treatment with LDE225.
- •7. Patients who are receiving other anti-neoplastic therapy concurrently or within 2 weeks of starting treatment with LDE225.
- •8. Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of CYP3A4/5 or drugs metabolized by CYP2B6 or CYP2C9 that have narrow therapeutic index, and that cannot be discontinued before starting treatment with LDE225. Medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with LDE225.
- •9. Pregnant or nursing (lactating) women
- •10. Women of child-bearing potential
- •11. Patients unwilling or unable to comply with the protocol.
- •Other protocol defined exclusion criteria may apply
研究者
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