A Phase II Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- the rate of response and stable disease
研究概览
简要总结
A phase II study to evaluate the safety and efficacy of oral sapacitabine in previously treated advanced non-small cell lung cancer (NSCLC).
详细描述
This is an open label, single arm, phase II study to evaluate the safety and efficacy of oral sapacitabine administered twice daily for 5 consecutive days every week for 2 weeks followed by 7-day rest in patients who have had one prior chemotherapy regimen for advanced Non-Small Cell Lung Cancer (NSCLC).
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
- •Histologically or cytologically confirmed recurrent NSCLC
- •Age of 18 years or older
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Measurable disease according to RECIST
- •Had only 1 prior chemotherapy regimen for metastatic or recurrent disease; patients who have received more than one prior chemotherapy regimens may participate in Part A of the study only.
- •Adequate bone marrow function
- •Adequate renal function
- •Adequate liver function
- •At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy; at least 7 days from prior radiation therapy; and have recovered from prior toxicities
- •At least 3 weeks from major surgery
- •Patient must be able to swallow capsules
- •Agree to practice effective contraception during the entire study period and for one month after being discontinued from the study unless documentation of infertility exists. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- •Ability to understand and willingness to sign the informed consent form
排除标准
- •NSCLC histology contains a component of small cell lung cancer
- •Previously untreated CNS metastasis or progressive CNS metastasis documented by MRI scan performed at 4 weeks or longer after the last treatment for CNS metastasis
- •Currently receiving radiotherapy, biological therapy, or any other investigational agents
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Cancer other than NSCLC that has been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer, and basal or squamous cell skin cancer; patients who received only hormonal therapy in the neoadjuvant or adjuvant setting in the past 5 years may participate in this study
- •Pregnant or lactating women
- •Known to be HIV-positive
研究组 & 干预措施
sapacitabine
Part A (lead-in phase): Two dosing schedules, i.e., once daily (q.d.) or twice daily (b.i.d.) x 5 days/week x 2 weeks every 3 weeks will be evaluated.
Part B (Phase 2): Receive the recommended phase 2 dose of once daily or twice daily dosing schedule derived from Part A.
干预措施: sapacitabine (Drug)
结局指标
主要结局
the rate of response and stable disease
时间窗: after cycle 2, 4, 7 and every 3 cycles thereafter
complete response or partial response and stable disease
次要结局
- duration of response(1.5 years)
- overall survival(1.5 years)
- duration of stable disease(1.5 years)
- progression-free survival(1.5 years)