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.

ZIOPHARM Oncology, Inc.0 个研究点目标入组 548 人开始时间: 2012年5月18日最近更新: 2015年7月10日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: ZIOPHARM Oncology, Inc.
入组人数: 548

研究概览入排标准研究者记录与标识符相似试验

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

•1. Male or female subjects, age = 18 years.
•2. Histological or cytological diagnosis of extensive-stage small cell lung cancer. (Note: Extensive-stage disease is defined as disease beyond the ipsilateral hemithorax, mediastinum and ipsilateral supraclavicular area and including malignant pleural or pericardial effusion or hematogenous metastases.)
•3. No prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer. Exception: Prior radiotherapy for brain metastases is allowed provided that the subject has recovered from any acute treatment related toxicity.
•4. Measurable or non-measureable disease as per RECIST v1.1 (Appendix 1).
•5. ECOG Performance Status of 0, 1, or 2 (Appendix 2).
•6. Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements: a. Hemoglobin =10.0 g/dL
•b. Absolute neutrophil count (ANC) =1,500/mm3
•c. Platelet count =100,000/mm3
•d. Total bilirubin =1.5 x upper limit of normal (ULN). For subjects with Gilbert’s Disease, Total bilirubin =3 x ULN
•e. ALT and AST =2.5 x ULN. For subjects with documented liver metastases, ALT and AST =5×ULN
•f. International Normalized Ratio (INR) =1.5, if not therapeutically anticoagulated. Subjects who are being therapeutically anticoagulated may be included provided
•that the anticoagulation regimen is stable and closely monitored.
•g. Estimated glomerular filtration rate (eGFR) = 60 mL/minute/1.73 m2 as determined using the Modification of Diet in Renal Disease (MDRD) equation (Appendix 3);
•in cases where the MDRD equation may not be suitable, a 24 hour urine creatinine clearance test may be substituted with prior approval of the Medical Monitor.
•7. Male and female subjects of child bearing potential must agree to use a double-barrier method of birth control from the screening visit through 6 months after the last dose of study drug.
•8. Written informed consent in compliance with the Human Investigation Review Committee (IEC/IRB) having jurisdiction over the site.
•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

•1. Exposure to any investigational agent within 30 days prior to randomization.
•2. Previously untreated (non-irradiated), symptomatic brain metastases. No prior treatment is required for non-symptomatic brain metastases. Previously treated symptomatic brain
•metastases are permitted.
•3. Known allergy to any of the study drugs or their excipients.
•4. Currently pregnant (confirmed with a positive serum pregnancy test) or nursing.
•5. Unstable or clinically significant concurrent medical condition, psychiatric illness or social situation that would, in the opinion of the investigator, jeopardize the safety of a subject and/or their compliance with the protocol.
•6. Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy within 7 days prior to randomization. (Suppressive therapy for chronic infections
•allowed, for example: Subjects with HIV/AIDS with adequate antiviral therapy to control viral load would be allowed. Subjects with viral hepatitis with controlled viral load would be allowed
•while on suppressive antiviral therapy.)
•7. Major surgery or significant traumatic injury within 28 days of the time of randomization.
•8. Presence of, or history of any illness or injury to the urinary tract (renal or post-renal) which may, in the opinion of the investigator, make the subject more susceptible to acute renal insufficiency.
•9. 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 SCLC may be enrolled after consultation with the medical monitor provided the patient’s prognosis is best defined by the ES-SCLC.)

研究者

发起方

ZIOPHARM Oncology, Inc.

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