Phase 2 Trial Evaluating the Safety and Tolerability of Intratumoral Injections of NanoPac® With Standard of Care Therapy in Subjects With Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events
研究概览
简要总结
This study evaluates the use of NanoPac injected directly into tumors in the lung of people with lung cancer.
详细描述
NanoPac is very small (submicron) particles of the chemotherapy drug, paclitaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, the submicron particle paclitaxel will be injected directly into tumors in the lungs of people with small cell or non-small cell lung cancer. All subjects in this study will receive NanoPac and will be evaluated to see if NanoPac is safe and has an effect on the tumor within the lung.
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
- •Signed informed consent;
- •Age ≥18 years and able to tolerate the EBUS-TBNI procedure;
- •Histologically/cytologically confirmed lung cancer. Eligible subjects may include, for example: primary or recurrent non-resectable disease, locally advanced stages II and III with nodal disease, stage IV advanced disease;
- •At least one lesion documented via imaging (within 4 weeks of Screening) which can be accessed using EBUS-TBNI;
- •Subject is not a candidate for surgery;
- •Has received or plans to receive SOC chemotherapy; adequate hematologic recovery must be confirmed according to the institution's SOC;
- •Performance Status (ECOG) 0-2 at study entry;
- •Life expectancy of at least 6 months;
- •Adequate marrow, liver, and renal function at study entry;
- •ANC ≥ 1.5 x 109/L;
- •Hemoglobin ≥ 9.0 grams/dL;
- •Platelets ≥ 75 x 109/L;
- •Total bilirubin ≤ 1.5x institutional ULN;
- •AST/ ALT ≤ 2.5x institutional ULN;
- •Creatinine ≤ 1.5x institutional ULN;
- •Appropriate steps taken to minimize or avoid the potential for pregnancy for subjects of child-bearing potential.*
排除标准
- •Significant cardiac disease (Class III or IV per New York Heart Association guidelines);
- •Active bacterial, viral, or fungal infections (including active AIDS, hepatitis B or hepatitis C);
- •Symptomatic central nervous system (CNS) metastasis which are neurologically unstable, or CNS disease requiring increase in steroid dose (treated metastatic disease and stable steroid use are not excluded)
- •Known hypersensitivity to study agent;
- •Pregnant or breastfeeding women.
研究组 & 干预措施
NanoPac
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart.
干预措施: NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events
时间窗: Day 1 to Week 24 (6 Months)
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
次要结局
- Concentration of Paclitaxel in the Systemic Circulation Post-injection(Day 1, Weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24)
- Progression Free Survival (PFS)(Weeks 24, 38, and 52)
- Overall Survival(Weeks 24, 38, and 52)
- Change in Tumor Dimensions (Longest Diameter)(Weeks 12, 24, 38, and 52)