EUCTR2011-006134-17-FR进行中（未招募）1 期
A Multi-center, Open-Label, Adaptive, Randomized Study of Palifosfamide-tris, a Novel DNA Crosslinker, in Combination with Carboplatin and Etoposide (PaCE) Chemotherapy versus Carboplatin and Etoposide (CE) Alone in Chemotherapy Naïve Patients with Extensive-Stage Small Cell Lung Cancer.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 188
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •· Documented extensive-stage small cell lung cancer
- •· Patient has received no prior chemotheraphy, adjuvant therapy, or radiotherapy for lung cancer
- •· ECOG Perforamce Status of 0, 1 or 2
- •· Adequate bone marrow and organ function based on the results of protocol- specified laboratory tests
- •· Male and female patients must agree to use a highly reliable method of birth control during study participation
- •· Able to provide informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 328
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 220
排除标准
- •· Previously untreated (non-irradiated), symptomatic brain metastases
- •· Known allergy to any of the study drugs or their excipients
- •· Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol, based on screening tests, physical examination and medical history (as specifically defined in the clinical protocol).
- •· Any malignancy other than small cell lung cancer within the last 5 years prior to randomization, with the exception of cervical carcinoma in situ, nonmelanoma skin cancer, or superficial bladder tumors (Ta, Tis, or T1) that have been successfully and curatively treated with no evidence of recurrent or residual disease. (Exception: Subjects with a history of malignancy other than small cell lung cancer may be enrolled after consulation with the medical monitor provided the patient’s prognosis is best defined by the extensive-stage small cell lung cancer).
- •· Currently pregnant or nursing.
研究者
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