A Single-arm, Single-institutional, Phase II Study Evaluating the Efficacy and Safety of Bacillus Cereus (Changfukang®) in the Prevention of Afatinib-associated Diarrhea in NSCLC Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Diarrhoea rate of all grades
研究概览
简要总结
Afatinib is an irreversible ErbB-family blocker with approved clinical activity in non-small-cell lung cancer (NSCLC) with EGFR mutations. It has received regulatory approval for use as a treatment for patients with lung adenocarcinoma whose tumors harbour activating EGFR mutations within exons 18-21 of the EGFR receptor, or patients with lung squamous cell carcinoma whose disease progress after platinum-based doublet chemotherapy. However, diarrhea is the most commonly reported adverse events associated with afatinib treatment (> 90%). Although these events are generally mild to moderate in severity, diarrhea adversely affects the tolerability of cancer treatment, and in severe cases diarrhea has the potential to affect the efficacy of treatment due to poor compliance, or treatment interruption, or dosage reduction. Currently, no prophylactic measure was demonstrated efficaciously. Bacillus cereus is an aerobic spore-forming bacterium that is commonly found in soil. The efficacy of Bacillus cereus in the management of afatinib treatment-associated diarrhoea has not been extensively evaluated in clinical studies. This is a single-arm, single-institutional, phase II study evaluating the efficacy and safety of Bacillus cereus (Changfukang®) in the prevention of afatinib-associated diarrhea in NSCLC patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed locally advanced or metastastic non-small-cell lung cancer
- •Suitable for the treatment of afatinib assessed by investigator
- •Age >=18 years old
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Life expectancy of at least 12 weeks
- •Able to swallow and retain oral medications
- •Women of childbearing potential must agree and commit to the use of a highly effective non-hormonal method of contraception, ie, intrauterine device, bilateral tubal ligation, vasectomized partner, or abstinence (only when it is the preferred lifestyle of the patient), from the time of informed consent until 28 days after the last dose of the investigational products. Men and their female partners of childbearing potential must agree and commit to use a highly effective method of contraception (ie, any of the above methods or hormonal contraception associated with inhibition of ovulation) while on treatment and for 3 months after last dose of investigational products
- •Provide written, informed consent to participate in the study and follow the study procedures
- •Patient has adequate bone marrow as defined by the following laboratory values:
- •White blood cell ≥ 3.0 × 109/L
- •Absolute neutrophil count ≥ 1.5 × 109/L
- •Platelets ≥ 75 × 109/L
- •Patient has adequate organ function as defined by the following laboratory values:
- •In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be below 2.5 × ULN. If the patient has liver metastases, ALT and AST should be < 5 × ULN
- •Total serum bilirubin < ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range of the central laboratory in patients with well documented
- •Gilbert's Syndrome
- •Serum creatinine ≤ 1.5 × ULN
排除标准
- •Previous treatment with EGFR-TKI or anti-EGFR antibody
- •History of gastrointestinal disease with diarrhea as the primary symptom in the last three months.
- •Another malignancy within 3 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer
- •Diagnosed as having CNS metastases, except those whose CNS disease were stable and dehydration treatment were unrequired within 4 weeks prior to the first dose of afatinib
- •Any severe and / or uncontrolled medical conditions
研究组 & 干预措施
Changfukang® group
Patients in Changfukang group will receive Changfukang® (Bacillus Cereus tablets).
干预措施: Bacillus Cereus tablets (Drug)
结局指标
主要结局
Diarrhoea rate of all grades
时间窗: Up to 4 weeks
Proportion of subjects experiencing diarrhoea of all grades, as defined by the National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03, recorded as AEs in the Electronic case report form (eCRF)
次要结局
- Days of diarrhoea of grade 2 and above(Up to 4 weeks)
- Diarrhoea rate of grade 2 and above(Up to 4 weeks)
- Diarrhoea rate of grade 3 and above(Up to 4 weeks)
- Proportion of subjects with AEs and SAEs(Up to 4 weeks)
- Days of diarrhoea of all grades(Up to 4 weeks)
- Days of diarrhoea of grade 3 and above(Up to 4 weeks)
- Proportion of subjects taking anti-diarrheal medication(Up to 4 weeks)
研究者
Li Zhang, MD
Professor
Sun Yat-sen University