NGR007: A Phase II Study of NGR-hTNF Administered in Combination With Doxorubicin Every 3 Weeks in Patients Affected by Advanced or Metastatic Small Cell Lung Carcinoma (SCLC) Previously Treated With at Least One Therapeutic Regimen
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 5
- 主要终点
- Antitumour Activity Defined as Progression Free Survival (PFS)
研究概览
简要总结
The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic small cell lung carcinoma (SCLC) patients previously treated with at least one therapeutic regimen
详细描述
This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic SCLC, previously treated with at least one therapeutic regimen, that will be conducted using Simon's two-stage design method.
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
- •Patients ≥ 18 years affected by SCLC previously treated with at least one therapeutic regimen (including doxorubicin). However, in case of patient already pretreated with doxorubicin, a previous cumulative dose of doxorubicin < 300 mg/m^2 is recommended and the current treatment has to be stopped when a maximum cumulative dose of doxorubicin 550 mg/m^2 is reached.
- •Cytology or histology confirmed SCLC at first diagnosis (patient with recurrent disease do not require a confirmatory biopsy to be eligible)
- •Measurable disease, defined as ≥ 1 unidimensional measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by CT scan according to RECIST criteria
- •ECOG Performance status 0 - 2
- •Adequate baseline bone marrow, hepatic and renal function, defined as follows:
- •Neutrophils > 1.5 x 10^9/L and platelets > 100 x 10^9/L
- •Bilirubin < 1.5 x ULN
- •AST and/or ALT < 2.5 x ULN in absence of liver metastasis
- •AST and/or ALT < 5 x ULN in presence of liver metastasis
- •Serum creatinine < 1.5 x ULN
- •Normal cardiac function (LVEF ≥ 55%) and absence of uncontrolled hypertension
- •Patients may have had prior therapy providing the following conditions are met:
- •Chemotherapy, radiation therapy, hormonal therapy or immunotherapy: wash-out period of 28 days before start treatment
- •Surgery: wash-out period of 14 days before start treatment
- •Patients must give written informed consent to participate in the study
排除标准
- •Concurrent anticancer therapy
- •Patients may not receive any other investigational agents while on study
- •Patients with myocardial infarction within the last six (6) months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
- •Uncontrolled hypertension
- •Prolonged QTc interval (congenital or acquired)
- •Patient with significant peripheral vascular disease
- •Previous signs of cardiotoxicity doxorubicin related
- •Clinical signs of CNS involvement
- •Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
- •Known hypersensitivity/allergic reaction or contraindications to human albumin preparations or to any of the excipients
- •Known hypersensitivity/allergic reaction or contraindications to anthracyclines
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
- •Pregnancy or lactation. Patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.
研究组 & 干预措施
A: NGR-hTNF + doxorubicin
NGR-hTNF plus doxorubicin
干预措施: NGR-hTNF (Drug)
A: NGR-hTNF + doxorubicin
NGR-hTNF plus doxorubicin
干预措施: Doxorubicin (Drug)
结局指标
主要结局
Antitumour Activity Defined as Progression Free Survival (PFS)
时间窗: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 150 weeks
Defined as the time from the date of randomization until disease progression, or death due to any cause or the last patient was known to be alive. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (Recist v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition the appearance of one or more new lesions was also considered progression
次要结局
- Tumor Growth Control Rate (TGCR)(Assessed every 6-12 weeks, up to 150 weeks)
- Overall Survival (OS)(Through study completion, an average of 3 years)
- Experimental Imaging Study (DCE-MRI)(during the study)
- Number of Adverse Events, Reported by Severity and Relation to Treatment(Through study completion, an average of 3 years)