EUCTR2012-000275-16-GR进行中（未招募）不适用
A pilot phase II trial of cabazitaxel in patients with metastatic NSCLC progressing after docetaxel-based treatment - n/a
Hellenic Oncology Research Group (H.O.R.G.)0 个研究点开始时间: 2012年8月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •-Age>18 years old
- •-Cytologically or histologically documented NSCLC
- •-PS 0-2 (WHO scale)
- •-Measurable disease according to RECIST v1.1 (at least one measurable lesion)
- •-Documented disease progression to previous treatment with docetaxel regimen in 1st or 2nd line setting assessed by Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) with at least one visceral or soft-tissue metastatic lesion.
- •-Brain metastases are allowed, given that are clinically stable and the patient does not present neurologic symptoms.
- •-Previous radiotherapy, either in the adjuvant setting or for the treatment of bone metastases, is allowed provided that the measurable lesions are outside the radiation fields. Patients who were irradiated to = 40% of bone marrow are not eligible for the study.
- •-Patients must have a recent (within 7 days prior to treatment start) biochemical and hematogical assessment as defined by adequate bone marrow (absolute neutrophil count =1.5 x 109 cells/L, platelets =100 x 109cells/L and hemoglobin =9 g/dL), liver (AST&ALT = 2.5x ULN, total bilirubin within normal range) and renal (serum creatinine < 1.5 x ULN). If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded) function tests.[18]
- •-Performance status 0-2 (WHO scale)
- •-Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- •-Before patient enrollment, written informed consent must be given according to ICH/GCP and national/local regulations.
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Persistence of clinically relevant treatment-related toxicities from previous chemotherapy or radiotherapy.
- •-Treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of treatment or concomitantly with this trial.
- •-Other malignancy within the past five years other than basal cell skin cancer or carcinoma in situ of the cervix.
- •-Patient with reproductive potential not implementing accepted and effective method of contraception
- •-History of severe hypersensitivity reaction (=grade 3) to polysorbate 80 containing drugs or to docetaxel
- •- Uncontrolled severe illness or medical condition (including uncontrolled diabetes
- •mellitus, hypertension, heart failure = NYHA II, history of myocardial infarction within the past 6 months, angina, chronic obstructive pulmonary disease (COPD), serious infections requiring systemic antibiotic therapy (e.g. antimicrobial, antifungal, antiviral)
- •-Concurrent or planned treatment with strong inhibitors or strong inducers of
- •cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who
- •are already on these treatments) (see Appendix A and B)
- •- Prior surgery, radiation, chemotherapy, within 4 weeks prior to treatment
- •- Active grade =2 peripheral neuropathy
- •- Active grade =2 stomatitis
研究者
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