Phase II Trial of CAP7.1 in Adult Patients With Refractory Malignancies: Small Cell Lung Carcinoma, Non-Small Cell Lung Carcinoma, Biliary Carcinoma (PIITCAP)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Time to disease progression
研究概览
简要总结
To assess the anti-tumor activity of CAP7.1 based on the observed objective response rate and rate of disease stabilization, as defined by the below primary and secondary endpoints, in patients with Non-Small Cell Lung Carcinoma (NSCLC), SCLC or biliary cancer who have progressed despite one or more previous chemotherapy line.
详细描述
A phase II evaluation will be performed in adult patients in parallel studies in 3 tumor types: NSCLC, SCLC and Biliary Tract Cancer. All patients will have advanced or metastatic disease with primary or secondary resistance to standard therapy. In each tumor type the patients will be randomized to receive either therapy with CAP7.1 or best supportive care according to institution standards. Patient in the Control group who progress may cross over to CAP7.1, however these patients will be analyzed separately from the patients randomized to CAP7.1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically- or cytologically-confirmed, advanced disease with documented progression (RECIST1.1.) after one or several chemotherapy line
- •Patients may also have received molecular targeted therapy and progressed while on therapy or after completion
- •Must have recovered from the acute reversible effects of previous anti-cancer chemotherapy, usually 3-4 weeks after myelosuppressive chemotherapy
排除标准
- •Serious concurrent medical condition, which could affect compliance with the protocol or interpretation of results.
- •Patients with uncontrolled infection and patients known to be infected with the human immunodeficiency virus (HIV) or hepatitis infection are not eligible for the study
- •Pregnancy or breast-feeding
研究组 & 干预措施
Small cell lung cancer
Histologically- or cytologically-confirmed, limited and extensive SCLC disease with progression after first or second line treatment
干预措施: CAP7.1 (Drug)
Non small cell lung cancer
Histologically- or cytologically-confirmed diagnosis of NSCLC with Stage IIIB or IV after failure of at least two lines of therapy
干预措施: CAP7.1 (Drug)
biliary tract cancer
Histologically or cytologically confirmed diagnosis of biliary tract cancer progress after first line therapy
干预措施: CAP7.1 (Drug)
结局指标
主要结局
Time to disease progression
时间窗: 18 month
Assessment of antitumor activity based on RECIST 1.1 criteria (complete response; partial response; stable disease)
次要结局
- Disease-free survival(Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months))
- 1. Percentage of Subjects With Objective Response [i.e., complete response (CR) + partial response (PR)] According to RECIST1.1(Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months))
- Overall Survival (OS)(Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months))
- Number of Subjects With Treatment Emergent Adverse Events (TEAEs)(Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months))
- Maximum Observed Drug Concentration (Cmax) of CAP7.1 in Plasma(Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months))
- Time to Reach Maximum Drug Concentration (tmax) of CAP7.1 in Plasma(Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months))
- Half-life Associated With the Terminal Slope (t1/2) of CAP7.1 in Plasma(Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months))
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of CAP7.1 in Plasma(Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months))
- Time to Treatment Failure(Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months))
- Progression-Free Survival (PFS)(Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months))