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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 22
- 主要终点
- Progression Free Survival (PFS) Rate
研究概览
简要总结
This is a prospective, multi-center, open-label, single-arm, non-randomized, Phase II study to evaluate the efficacy and safety of TKI258 as second-line therapy in patients with either FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
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
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 inclusion/exclusion criteria may apply
研究组 & 干预措施
TKI258
1 treatment arm (single agent TKI258), with patients classified into 2 groups based on their FGFR2 mutation status
干预措施: TKI258 (Drug)
结局指标
主要结局
Progression Free Survival (PFS) Rate
时间窗: up to 18 weeks
The 18-week PFS was defined as the percentage of participants who did not have a progression event at week 18. Participants who progressed, died, had response assessment of unknown (UNK) or discontinued before 18 weeks of observation without progression were counted as "failure". Progressive disease was assessed as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
次要结局
- Disease Control Rate (DCR)(Baseline and every 6 weeks until disease progression, up to 18 weeks)
- Number of Participants With Adverse Events, Serious Adverse Events and Deaths(up to 30 days after the last dose of study drug, up to 18 weeks)
- Progression Free Survival (PFS)(up to 18 weeks)
- Overall Survival (OS)(up to 18 weeks)
- Overall Response Rate (ORR)(Baseline and every 6 weeks until disease progression, up to 18 weeks)
- Duration of Response (DR)(up to 18 weeks)