JPRN-UMIN000006744已完成1 期
Phase I/II study of bexarotene capsule (BSC-1) in patients with Cutaneous T-cell Lymphoma (CTCL) - Phase I/II study of bexarotene capsule (BSC-1) in patients with Cutaneous T-cell Lymphoma (CTCL)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Cutaneous T-cell lymphoma involving the central nervous system 2. Subjects with known adult T-cell leukemia/lymphoma 3. Systemic antibiotic therapy within 2 weeks of entry in the study 4. Topical CTCL therapy, regional chemotherapy, topical steroid and other, within 2 weeks of entry the study 5. PUVA or UVB therapy within 3 weeks 6. Radiation therapy within 4 weeks of entry to the study 7. Systemic anticancer therapy of any kind within 4 weeks of entry to the study 8. Systemic therapy with Vitamin A in doses of greater than 15,000 IU, 5,000 mcg, per day within 4 weeks of entry to the study 9. Received systemic steroids within 4 weeks of entry in the study 10. Participation in any other investigational drug study within 12 week of entry in this study 11.Received Etretinate therapy within one year of entry in the study 12. Patients with pregnancy, intent to become pregnant, breast-feeding or unwillingness to effective contraception. 13. Subjects have critical intercurrent illness or serious infection diseases 14. History of pancreatitis or significant risk factors for developing pancreatitis (e.g., prior pancreatitis, uncontrolled hyperlipidemia, excessive alcohol consumption, uncontrolled diabetes mellitus, biliary tract disease, and medications known to increase triglyceride levels or to be associated with pancreatic toxicity 15. Known or suspected hypersensitivity to bexarotene or any other retinoid preparations 16. Known serious allergic reaction or critical hypersensitivity to drugs 17. Unwillingness or inability to minimize exposure to sunlight and artificial ultraviolet light 18. Principal investigator judged inadequate
研究者
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