EUCTR2011-000266-35-ES进行中（未招募）不适用
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 Farmacéutica S.A0 个研究点目标入组 80 人开始时间: 2012年3月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- Female
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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