ISRCTN96922360已完成1 期
Phase I dose escalation study of oral administration of Pan-Histone Deacetylase (HDAC) inhibitor S 78454 given in combination with a fixed dose infusion of cisplatin in patients with advanced non-keratinising nasopharyngeal carcinoma.
Institut de Recherches Internationales Servier (France)0 个研究点目标入组 40 人开始时间: 2012年6月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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
- 性别
- All
入选标准
- •1. Male or female patients aged =21 (Singapore) =20 (Taiwan)
- •2. Histologically documented, measurable or evaluable advanced non-keratinising nasopharyngeal carcinoma, that has relapsed or is refractory to conventional, standard forms of therapy.
- •3. Ability to swallow oral capsule(s) without difficulty
- •4. Eastern Cooperative Oncology Group (ECOG) performance status = 1
- •5. Estimated life expectancy > 12 weeks
- •6. Adequate haematological, renal and hepatic functions-Serum albumin 30 g/L
- •7. Written informed consent
排除标准
- •1. Pregnant or breastfeeding women, women of childbearing potential or men without effective contraception
- •2. Involvement in another clinical trial at the same time or within 4 weeks prior to inclusion, or patient already enrolled in the study
- •3. Major surgery within previous 4 weeks
- •4. Chemotherapy within previous 3 weeks (6 weeks in case of nitroso-ureas)
- •5. Biologic/target therapy or immunologic agents within previous 3 weeks
- •6. Radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions)
- •7. Abnormal thyroid function (defined as thyroid-stimulating hormone or free T4) except for patients with hypothyroidism diagnosed prior to study entry and stable on thyroid replacement
- •8. Concurrent therapeutic anticoagulation by anti-vitamin K (AVK)
- •9. Uncontrolled diabetes mellitus
- •10. Concomitant uncontrolled infection or severe systemic disease
- •11. Symptomatic or progressive brain metastasis
- •12. Patients with pre-existing gastrointestinal disorders
- •13. Patient with impaired cardiac function
- •14. Prior exposure to any Histone deacetylase inhibitors (HDACi)
- •15. Known organ dysfunction
- •16. Peripheral neuropathy > grade 1
- •17. Hearing impairment/tinnitus > grade 2
- •18. Known hypersensitivity to cisplatin
研究者
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