NCT00435578终止2 期
An Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of Glufosfamide in the Treatment of Patients With Recurrent Sensitive Small Cell Lung Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 6
研究概览
简要总结
The primary objectives of this study are:
- To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive small cell lung cancer (SCLC) as measured by objective response rate
- To evaluate the safety of glufosfamide in subjects with extensive recurrent sensitive SCLC
The secondary objectives are:
- To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive SCLC as measured by duration of response, progression-free survival and overall survival
- To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard (IPM)
The exploratory objectives of this trial are:
- To evaluate the effect of glufosfamide on lung cancer symptoms
- To evaluate the role of tumor cell glucose transporter expression on the efficacy of glufosfamide
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •At least 18 years of age
- •Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/IEC
- •Documented extensive SCLC with progression occurring at least 60 days after completion of first-line therapy (sensitive disease)
- •Measurable disease by RECIST criteria (at least one target lesion; no target lesion may have received radiotherapy within 6 weeks of study start)
- •A minimum of 21 days between prior radiation therapy, immunotherapy, or other anti-tumor therapy and study entry
- •Recovered from reversible toxicities of prior therapy
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
- •Hemoglobin ≥ 9.0 g/dL, ANC ≥ 1,500/µL, platelets ≥ 100,000/µL
- •Total bilirubin ≤ 1.5-fold ULN
- •AST/ALT ≤ 2.5-fold ULN (≤ 5-fold ULN if liver metastases)
- •Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft-Gault formula)
- •All women of childbearing potential and all men must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose
排除标准
- •More than one previous chemotherapy regimen
- •Concomitant or planned hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for SCLC other than protocol therapy
- •Limited stage SCLC (defined as confined to one hemithorax including ipsilateral supraclavicular lymph nodes and excluding pleural effusion)
- •Symptomatic brain metastases requiring corticosteroids
- •Active clinically significant infection requiring antibiotics
- •Known HIV positive or active hepatitis B or C
- •Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, congestive heart failure, or stroke
- •Other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past 5 years
- •Major surgery within 28 days of the start of study treatment, without complete recovery
- •Females who are pregnant or breast-feeding
- •Participation in an investigational drug or device study within 28 days of the first day of dosing on this study
- •Concomitant disease or condition that could interfere with the conduct of the study, or that, in the opinion of the investigator, could pose an unacceptable risk to the subject in this study.
- •Unwillingness or inability to comply with the study protocol for any other reason
研究者
研究点 (6)
Loading locations...
相似试验
已完成
2 期
Safety and Efficacy Study of Glufosfamide in Previously Treated Advanced Soft Tissue SarcomaSoft Tissue SarcomaNCT00441467Eleison Pharmaceuticals LLC.22
已完成
3 期
Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic CancerPancreatic CancerNCT00099294Threshold Pharmaceuticals300
已完成
2 期
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.Non Small Cell Lung CancerNCT00160043Bayer112
已完成
2 期
A Study to Evaluate Oral VT-464 in Patients With Castration-Resistant Prostate CancerCastration-resistant Prostate CancerCRPCNCT02012920Innocrin Pharmaceutical200
尚未招募
1 期
A Study in Subjects With Human Papillomavirus 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3Human Papillomavirus Associated Intraepithelial NeoplasiaCervical Intraepithelial Neoplasia Grade 2/3Human Papillomavirus Type 16 InfectionHuman Papillomavirus Type 18 InfectionNCT06273553RinuaGene Biotechnology Co., Ltd.39