EUCTR2004-004206-25-IE进行中（未招募）1 期
A PHASE II MULTICENTRE RANDOMISED, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ZD1839 (IRESSA TM) (250MG TABLET) PLUS BEST SUPPORTIVE CARE (BSC) VERSUS PLACEBO PLUS BSC IN CHEMOTHERAPY-NAÏVE PATIENTS WITH ADVANCED (STAGE IIIB OR IV) NON-SMALL CELL LUNG CANCER (NSCLC) AND POOR PERFORMANCE STATUS - INSTEP
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 201
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.Provision of written informed consent
- •2.Male or female, aged 18 years and over
- •3.Histologically or cytological confirmation of non-small cell lung carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma. This may be from the initial diagnosis of NSCLC or subsequent biopsy. Note: sputum cytology alone is not acceptable. Cytological specimens obtained by brushing, washing or needle aspiration of a defined lesion are acceptable
- •4.NSCLC, locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
- •5.Measurable disease according to RECIST criteria with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
- •6.Ability to provide plasma and urine samples for biomarker analysis
- •7.WHO performance status (PS) of 2 or 3
- •8.Not considered suitable for chemotherapy
- •9.No prior chemotherapy, biological or immunological therapy (including adjuvant and neoadjuvant). Prior surgery and/or localized irradiation is allowed
- •10.Life expectancy of at least 9 weeks
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Newly diagnosed CNS metastases that have not yet been definitively treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically stable disease (off steroids or in presence of a tailing steroid dose) for at least 4 weeks
- •2.Less than 4 weeks since completion of prior radiotherapy or persistence of any radiotherapy related toxicity.
- •3.Known severe hypersensitivity to ZD1839 or any of the excipients of this product
- •4.Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •5.Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy (except alopecia)
- •6.As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- •7.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than
- •5 times the upper limit of the reference range (ULRR)
- •8.Absolute neutrophil counts (ANC) less than 1.0 x 109/L or platelets less than
- •100 x 109/L
- •9.Serum bilirubin greater than 3 times the upper limit of the reference range (ULRR)
- •10.Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
- •11.Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
- •12.Pregnancy or breastfeeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
- •13.Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John’s Wort
- •14.Prior treatment with EGFR inhibitors
- •15.Treatment with a non-approved or investigational drug within 30 days before
- •Day 1 of study treatment
研究者
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