CTRI/2014/08/004907已完成3 期
An open label, multicentre, single-arm trial to assess the safety of afatinib for patients with locally advanced or metastatic non-small celllung cancer (NSCLC) harboring EGFR mutation(s)
Boehringer Ingelheim Hongkong0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)
- •-presence of Epidermal Growth Factor Receptor (EGFR) mutation in tumour biopsy.
- •Results of EGFR mutation must be available before enrolment in this trial. No
- •rebiopsy is required for purpose of this trial.
- •-male or female patients age greater than or equal to 18 years and less than or equal to 75 years
- •-adequate organ function, defined as all of the following:
- •-Left Ventricular Ejection Fraction (LVEF) >50% or within institution normal values
- •-Absolute Neutrophil Count (ANC) greater than 1500/mm3. (ANC greater than 1000/mm3 may be
- •considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor).
- •-Platelet count greater than 75,000/mm3
- •- Serum creatinine less than 1.5 times of the upper limit of normal
- •- Total Bilirubin less than 1.5 times upper limit of (institutional) normal (Patients with Gilbertâ??s syndrome total bilirubin must be less than 4 times institutional upper limit of normal)
- •- Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) less than three times the upper limit of (institutional) normal (ULN) (if related to liver metastases less than five times ULN)
- •-ECOG score between 0 â?? 2
- •-written informed consent by patient or guardian prior to admission into the trial that is
- •consistent with International Conference on Harmonisation (ICH)- Good Clinical
- •Practice (GCP) guidelines and local law.
排除标准
- •-prior treatment with an EGFR tyrosine kinase inhibitor (TKI)
- •- hormonal anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted)
- •-radiotherapy within 14 days prior to drug administration, except as follows:
- •-Palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
- •- Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling
- •- major surgery within 4 weeks from day 1 of first dose of afatinib. At least 7 days should have elapsed since minor surgical proceduring including placement of an access device or fine needle aspiration and at least 14 days for diagnostic or palliative video-assisted thoracoscopic surgery (VATS)
- •- known hypersensitivity to afatinib or any of its excipients
- •- history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of greater than 3 (Refer to Appendix 10.2), unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within
- •6 months prior to starting trial treatment.
- •- Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use medically acceptable method of contraception during the trial entry and for at least 2 weeks after treatment has ended. Adequate methods of contraception and Women of Child-Bearing Potential described in Section 4.2.3.
- •Perimenopausal women must be amenorrhoeic for at least 24 months to be considered for non-childbearing potential.
- •childbearing potential (see Section 4.2.3) who:
- •a. are nursing or
- •b. are pregnant or
- •c. are not using an acceptable method of birth control, or do not plan to continue
- •using this method throughout the trial and/or do not agree to submit to pregnancy testing required by this protocol
- •- history of or co-existing condition that, in the opinion of the investigator, would compromise the patientâ??s ability to comply with the trial or interfere with the evaluation of safety for the trial drug
- •- previous or concomitant malignancies at other sites, except effectively treated nonmelanoma
- •skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
- •- requiring treatment with any of the prohibited concomitant medications listed in Section 4.2.2 that can not be stopped for the duration of trial participation
- •- known pre-existing interstitial lung disease
- •- presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. Crohnâ??s disease, ulcerative colitis, malabsorption, or CTC grade greater than or equal to 2 diarrhoea of any aetiology) based on investigator assessment
- •- Known active hepatitis B infection (defined as presence of Hepatitis B (HepB) sAg and/or HepB DNA), active Hepatitis C (HEP C) infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier.
- •- meningeal carcinomatosis
- •- symptomatic brain metastases (patients with as
研究者
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