EUCTR2012-003361-18-AT进行中（未招募）1 期
Phase II trial of oral vinorelbine in Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR) positive mutation after a failure to treatment with EGFR Tyrosine Kinase Inhibitors (TKI) in first line.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
入选标准
- •- The patient must give written (personally signed and dated) informed consent before completing any study-related procedure.
- •- Patients > or = 18 years.
- •- Histologically or cytologically confirmed NSCLC.
- •- Patients with epidermal growth factor receptor (EGFR) positive mutation.
- •- Patients progressing or relapsing after treatment with EGFR tyrosine kinase inhibitors but a minimum of 2 weeks must have elapsed prior to start of study treatment.
- •- Performance status KPS > or = 70% (ECOG/WHO PS 0-1).
- •- Stage IIIB (with supra-clavicular nodal metastases), stage IV.
- •- Life expectancy more than 12 weeks.
- •- Adequate bone marrow, hepatic and renal functions:
- •Neutrophils > or = 2.0 x 10^9/l, Platelets > or = 100 x 10^9/l, Haemoglobin > or = 10.0 g/dL;
- •Total bilirubin < or = 1.5 x ULN (Upper Limit of Normal), Transaminases (ALT, AST) < 2.5 x ULN, Alkaline Phosphatases < 5 x ULN;
- •Calculated creatinine clearance > or = 40 ml/min (Cockcroft and Gault formula).
- •- Prior therapy:
- •Chemotherapy: patient must not have had systemic chemotherapy or
- •immunotherapy (monoclonal antibody);
- •Radiation therapy: patient is eligible if presence of target lesions outside the irradiated area. A minimum of 4 weeks must have elapsed prior to start of study treatment.
- •- Presence of at least one measurable lesion (measured in at least one dimension) which has not been previously irradiated (RECIST criteria – version 1.1). Physical examination and ultrasound will not be considered as objective tumour assessments.
- •- Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
- •- Women of childbearing potential must be using a medically accepted method of contraception (i.e. oral contraceptives, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimised. Women of childbearing potential must have
- •a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment.
- •- Fertile men must be using an effective method of birth control if their partners are women of childbearing potential throughout the study period and for up to 3 months after the last dose of study treatment.
- •- The patient must have access to social insurance according to 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 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 27
排除标准
- •Patients with at least one of the following criteria will not be included:
- •- Known hypersensitivity to the study drug or to drugs with similar chemical structures.
- •- Participation in another clinical trial with any experimental drug within the 30 days before registration and/or during the study.
- •- Any important factor likely to modify drug absorption (e.g. surgery of the gastrointestinal tract, significant malabsorption syndrome or disease affecting the gastrointestinal tract function).
- •- Previous radiotherapy in the only site used to assess response.
- •- Clinically relevant or unstable systemic disease making implementation of the protocol difficult.
- •- Active central nervous system disorder, brain metastasis or leptomeningeal involvement.
- •- Symptomatic neuropathy (sensory) > or = grade 2 according to the NCI Common Toxicity Criteria (NCI – CTC version 2).
- •- Weight loss > 10% within the previous 3 months.
- •- Long term oxygen therapy.
- •- Concomitant/uncontrolled medical disorder (cardiac failure or myocardial infarction within the previous 3 months, uncontrolled hypertension or arrhythmia, uncontrolled hypercalcaemia, active infection requiring i.v. antibiotics within 2 weeks before the beginning of treatment).
- •- Women if pregnant or lactating or with positive pregnancy test at inclusion;
- •- Women of childbearing potential who did not use or is unwilling or unable to use an acceptable method to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment.
- •- Sexually active fertile men not using effective method of birth control method throughout the study period and for up to 3 months after the last dose of study treatment if his partner is a woman of childbearing potential.
- •- Other malignancies except adequately treated basal carcinoma of the skin, in-situ cervix carcinoma or any other tumor with a disease free interval > 5 years.
研究者
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