ISRCTN68849558已完成1 期
Phase I study of oral administration of S 78454 given with a fixed dose infusion of pegylated liposomal doxorubicin in the treatment of primary platinum-resistant and partially platinum-sensitive, epithelial ovarian, fallopian tube or primary peritoneal carcinoma
Pharmacyclics LLC (USA)0 个研究点目标入组 70 人开始时间: 2013年9月16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
- 70
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
- Female
入选标准
- •1. Female patient aged 18 years or above
- •2. Histologically confirmed diagnosis of advanced relapsed epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, with measurable and evaluable disease
- •3. Platinum resistant and partially platinum sensitive tumour
- •4. Ability to swallow oral capsule(s) without difficulty
- •5. Estimated life expectancy of more than 12 weeks
- •6. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- •7. Adequate haematological, renal and hepatic functions
排除标准
- •1. Pregnant or breast-feeding women, women for whom fertility function has been preserved without effective contraception
- •2. Major surgery within previous 4 weeks
- •3. Chemotherapy within previous 3 weeks (6 weeks in case of nitrosoureas)
- •4. Radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions)
- •5. Immunotherapy or hormonotherapy within previous 2 weeks, except stable oral glucocorticoid and mineralocorticoid replacement for adrenal insufficiency, stable mitotane for adrenal carcinoma or oral contraceptives or hormonal replacement therapy
- •6. Risk factors for, or use of drugs known to prolong QTc interval and that may be associated with Torsades de Pointes
- •7. Patients treated by valproic acid within previous 5 days before
研究者
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