A Phase II single-arm trial of BIBW 2992 in demographically and genotypically selected non-small cell lung cancer patients - BIBW 2992 in demographically / genotypically NSCLC

SCS Boehringer Ingelheim Comm.V0 个研究点目标入组 40 人2008年6月6日

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简要总结

暂无简介。

注册库

who.int

开始日期

2008年6月6日

结束日期

2012年6月19日

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

SCS Boehringer Ingelheim Comm.V

入排标准

入选标准

•1\.Patients with pathologically confirmed diagnosis of NSCLC Stage IIIB (with pleural effusion) or Stage IV; histopathological classification of adeno\- or bronchoalveolar carcinoma (BAC).
•2\.non smokers patients or patients having smoked less than 15 pack years and who stopped smoking for at least one year before diagnosis (for cohorts 1 and 2\)
•3\.Presence of activating mutation(s) in exon 18 to exon 21 of the EGFR or HER2\-neu\-receptor confirmed by direct DNA sequencing of NSCLC tumour tissue (see Section 3\.3\.3\) or increased copy number of the EGFR gene as determined by FISH analysis
•4\.Prior treatment:
•Cohort 1: progressive disease following therapy with first line EGFR TKI following diagnosis of activating mutation
•Cohort 2: No prior EGFR TKI, up to three lines of chemotherapy (including adjuvant)
•Cohort 3: no restrictions
•5\.Patients with at least one tumour lesion that can accurately be measured by computed tomography (CT) or magnetic resonance imaging (MRI) in at least one dimension with longest diameter to be recorded as \=20 mm using conventional techniques or \=10 mm with spiral CT scan.
•6\.Male or female patient aged \=18 years
•7\.Life expectancy of at least three (3\) months.

排除标准

•1\.More than three (3\) prior cytotoxic chemotherapy treatment regimens for relapsed or metastatic NSCLC, except for patients with HER2\-neu mutations who may have received any prior therapy
•2\.Chemo\-, hormone\- (other than Megace® or steroids required for maintenance non\-cancer therapy) or immunotherapy within the past 4 weeks or within less than four half\-lives of the previous drug prior to treatment with the trial drug and/or persistence of toxicities of prior anticancer therapies which are deemed to be clinically relevant.
•3\.Brain metastases, which are symptomatic; patients with treated, asymptomatic brain metastases are eligible with stable brain disease for at least four (4\) weeks without the requirement for steroids or anti\-epileptic therapy.
•4\.Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom e.g., Crohn’s disease, malabsorption, or CTCAE Grade \>2 diarrhoea of any etiology at baseline
•5\.Patients who have any other life\-threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug
•6\.Other malignancies diagnosed within the past five (5\) years (other than non melanomatous skin cancer and in situ cervical cancer).
•7\.Radiotherapy within the past 2 weeks prior to treatment with the trial drug
•8\.Patients with any serious active infection (i.e., requiring IV antibiotic, antifungal, or antiviral agents).
•9\.Patients with known HIV, active hepatitis B or active hepatitis C (see Section 5\.2\.3\).
•10\.Known or suspected active drug or alcohol abuse.