NCT03762161Unknown2 期
A Phase II Study of TAS-102 in Metastatic Platinum and Checkpoint Inhibitor-resistant Bladder Cancer
Rahul Parikh2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年1月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Clinical benefit rate (complete response+ partial response+ stable disease)
研究概览
简要总结
This study evaluates the clinical benefit of TAS-102 in participants with metastatic urothelial carcinoma who are resistant to cisplatin or carboplatin front-line and checkpoint inhibitors as second line therapy. All participants will receive TAS-102 in oral form twice per day on Days 1-5 and Days 8-12 of each 28 day cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Ability of participant to understand this study, and participant willingness to sign a written informed consent.
- •Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic urinary bladder (urothelial) cancer. Participants with mixed histologies are permitted as long as transitional cell carcinoma is present in the pathological specimen.
- •Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
- •Documented progression on or within 12 months of treatment with one previous platinum-containing regimen or ineligible to receive platinum-containing regimen. Neo-adjuvant or adjuvant platinum-based chemotherapy will be deemed to be first-line when participants progressed within 12 months of the last dose
- •Documented progression on prior checkpoint inhibitor or ineligible to receive check-point inhibitor
- •Adequate performance status, organ, and marrow function.
- •Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception.
- •Men of child-bearing potential must not father a child or donate sperm while on this study and for 6 months after their last study treatment
排除标准
- •Patients who have had chemotherapy or radiotherapy within 4 weeks of enrollment/registration.
- •Current or anticipated use of other investigational agents while participating in this study.
- •Psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant or breast feeding (if applicable).
- •Patients with known brain metastases
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS
- •Patients with HIV on anti-retro-viral therapy with thymidine kinase substrates, for example, stavudine, zidovudine, telbivudine.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Undergoing active treatment for a co-existing malignancy with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, thyroid cancer or incidental prostate adenocarcinoma detected at radical cystectomy
研究组 & 干预措施
Intervention TAS-102
Experimental
干预措施: TAS 102 (Drug)
结局指标
主要结局
Clinical benefit rate (complete response+ partial response+ stable disease)
时间窗: Up to 6 months
Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
次要结局
- Overall survival rate (OS) among participants(Up to 12 months)
- Progression-free survival rate (PFS) among participants(Up to 6 months)
- Proportion of participants with Grade 3 or higher Adverse and Serious Adverse Events(Up to 26 months)
- Overall change in patient-reported quality of life outcomes(Up to 26 months)
- Overall response rate (ORR) among participants(Up to 12 months)
研究者
Rahul Parikh
Principal Investigor
University of Kansas Medical Center
研究点 (2)
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