NCT01931787已完成1 期
A Pilot Clinical Trial of CPI-613 in Patients With Relapsed or Refractory Small Cell Lung Carcinoma (SCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Tumor response rates, defined as the proportion of patients who achieve complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD)
研究概览
简要总结
This pilot clinical trial studies CPI-613 (6,8-bis[benzylthio]octanoic acid) in treating patients with relapsed or refractory small cell lung cancer. CPI-613 may interfere with the growth of tumor cells and may be an effective treatment for small cell lung cancer.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the safety and anti-cancer activities in patients with relapsed or refractory small cell lung cancer (SCLC) who have failed 1 or 2 lines of chemotherapy.
OUTLINE:
Patients receive CPI-613 intravenously (IV) over 2 hours on days 1 and 4 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 2 months.
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 proven SCLC that has relapsed or been refractory from at least one line of chemotherapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of =< 3
- •Expected survival > 1 month
- •No acute toxicities from previous treatment higher than grade 1 at the start of treatment with CPI-613
- •Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation
- •Men must practice effective contraceptive methods during the study, unless documentation of infertility exists
- •Platelet count >= 100,000 cells/mm^3 or >= 100 bil/L
- •Absolute neutrophil count (ANC) >= 1500 cells/mm^3 or >= 1.5 bil/L
- •Aspartate aminotransferase (AST/serum glutamic oxaloacetic transaminase [SGOT]) =< 3 x upper normal limit (UNL)
- •Bilirubin =< 1.5 x UNL
- •Serum creatinine =< 1.5 mg/dL or 133 µmol/L
- •Albumin > 2.0 g/dL or > 20 g/L
- •Mentally competent, ability to understand and willingness to sign an Institutional Review Board (IRB)-approved written informed consent form
- •Have access via central line (e.g., portacath)-double lumen due to CPI-613 administration requirements
排除标准
- •Patients receiving any other standard or investigational treatment for their cancer, or any investigational agent for any non-cancer indication within the past 2 weeks prior to initiation of CPI-613 treatment
- •Serious medical illness that would potentially increase patients' risk for toxicity
- •Any active uncontrolled bleeding or bleeding diathesis
- •Pregnant women, women of child-bearing potential not using reliable means of contraception, or lactating women
- •Men unwilling to practice contraceptive methods during the study period
- •Life expectancy less than 1 month
- •Treatment with any anti-cancer therapy within the 2 weeks prior to treatment with CPI-613
- •Patients with untreated central nervous system (CNS) or epidural tumor
- •Any condition or abnormality which may, in the opinion of the investigator, compromise his or her safety
- •Unwilling or unable to follow protocol requirements
- •Active heart disease including myocardial infarction within previous 6 months, symptomatic coronary artery disease, arrhythmias not controlled with medication, or symptomatic congestive heart failure
- •Evidence of active infection or serious infection (e.g., septic shock with multi-organ dysfunction) within the past month
- •Patients with known human immunodeficiency virus (HIV) infection
- •Requirement for immediate palliative treatment of any kind including surgery
研究组 & 干预措施
Treatment (CPI-613)
Experimental
Patients receive CPI-613 IV over 2 hours on days 1 and 4 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: 6,8-bis(benzylthio)octanoic acid (Drug)
结局指标
主要结局
Tumor response rates, defined as the proportion of patients who achieve complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD)
时间窗: Up to 3 years
The proportion of responders as the percent of patients who are SD, PR and CR will be estimated, as well as RR (sum of PR + CR) and disease control rate (DCR, which is the sum of SD, PR and CR). 95% confidence intervals will be included.
次要结局
- Progression-free survival (PFS)(Up to 3 years)
- Overall survival (OS)(Up to 3 years)
研究者
研究点 (1)
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