Trial of afatinib (BIBW 2992) in suspected or confirmed mutant EGFR lung cancer patients unfit for chemotherapy - TIMELY

niversity College London0 个研究点目标入组 37 人开始时间: 2011年11月1日最近更新: 2019年2月28日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 37

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

入选标准

•Patient Inclusion Criteria
•1. Any stage not suitable for radical treatment
•Confirmed activating EGFR mutation (exons 18-21; eg L858R, exon 19 deletions, exon 20 insertions, T790M, this list is not exhaustive) and WHO PS 0-3
•No tissue suitable for EGFR genotyping, failed genotype, or EGFR genotyping unavailable, and
•NSCLC Adenocarcinoma sub-type (including any WHO variant – see Appendix 4), and
•Eligible smoking history:
•- Never smoker (<100 cigarettes in lifetime), or
•- Former smoker (stopped >1year ago and =10 pack-years)
•and WHO PS 0-2
•3. Predicted life expectancy = 8 weeks
•4. Unsuitable for or patient declining chemotherapy due to significant co-morbidity
•5. Measurable disease according to RECIST version 1.1
•6. Age 18 or over (no upper age limit)
•7. Adequate haematopoietic, hepatic and renal function defined as follows:
•Absolute neutrophil count (ANC) =1.5 x 109/L and platelet count =100 x 109/L
•Bilirubin =1.5 x ULN, ALT/AST(SGPT/SGOT) =3 x ULN (or = 5 x ULN in cases of liver metastases)
•8.Serum creatinine clearance =45 ml/min using any local method
•9. Palliative radiotherapy allowed unless to a solitary target lesion
•10. Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 0

排除标准

•Exclusion Criteria
•1. Previous treatment with BIBW 2992, or any EGFR-directed inhibitor
•2. Any concurrent anticancer systemic therapy
•3. Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and registration
•4. Suitable for radical radiotherapy
•5. Palliative radiotherapy within 2 weeks prior to registration
•6. Palliative radiotherapy to a solitary target lesion
•7. Surgery (other than biopsy) within 4 weeks prior to registration
•8. Inability to take oral medication, requirement for intravenous feeding, active peptic ulcer, prior surgical procedures affecting absorption or, any medical co-morbidity affecting gastrointestinal absorption
•9. Patients with current or pre-existing interstitial lung disease
•10. Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient’s participation in the trial
•11. Significant or recent acute gastrointestinal abnormalities with diarrhoea as a major symptom e.g., Crohn’s disease, mal-absorption, or CTCAE v4.0 Grade =3 diarrhoea of any etiology at baseline
•12. Active brain metastases (defined as stable for <4 weeks and/or symptomatic and/or requiring treatment with anticonvulsants and/or leptomeningeal disease. Steroids will be allowed if administered as a stable (same) dose for at least one month before trial entry
•13. Any other current malignancy or malignancy diagnosed within the past five years (other than non-melanomatous skin cancer and in situ cervical cancer)
•14. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3 or more, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to registration
•15. Symptomatic left ventricular failure with NYHA classification of 3 or more
•16. Active viral hepatitis and/or known HIV positive
•17. Known or suspected active drug or alcohol abuse
•18. Use of any investigational drug within 8 weeks of registration
•19. Known allergy to BIBW 2992 or other ingredients
•20. Patients who have not been on the same dose of steroids for at least 4 weeks.
•21. Inability to understand or to comply with the requirements of the trial, trial protocol or to provide informed consent
•22. Women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial
•23. Women who are pregnant or breast feeding
•24. Requirement for treatment with any of the prohibited concomitant medications listed in protocol

研究者

发起方

niversity College London

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