EUCTR2011-000266-35-GB进行中（未招募）1 期
A phase II, open-label, single-arm, non-randomized, multi-center study to evaluate the efficacy of oral TKI258 as second-line therapy in patients with either FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer
ovartis Pharma Services0 个研究点目标入组 53 人开始时间: 2012年4月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 53
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
入选标准
- •Patients with histologically confirmed diagnosis of advanced and/or metastatic endometrial cancer with available tissue specimen (either archival tissue or fixed fresh biopsy)
- •Female patients >= 18 years old
- •Documented radiologically confirmed progression of disease after prior first-line treatment evidence of progressive disease
- •ECOG (Eastern Cooperative Oncology Group) performance status = 2
- •At least one measurable lesion as per RECIST
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Previous treatment with an FGFR inhibitor
- •More than one line of treatment for advanced or metastatic disease
- •Patients with uterine sarcomas, adenosarcoma, and malignant Mullerian tumors
- •Patients with isolated recurrences (vaginal, pelvic, or para-aortic) potentially curative with radiation therapy or surgery
- •Known central nervous system (CNS) metastases
- •Malignancy within 3 years of study enrollment
- •Other protocol-defined exclusion criteria may apply
研究者
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