Explore the Relationship Between Single Nucleotide Polymorphisms and Topotecan Response and Toxicity in Patients With Small Cell Lung Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Find Topotecan Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
研究概览
简要总结
Explore the relationship between drug target topoisomerase I gene single nucleotide polymorphisms and Topotecan therapeutic-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.
Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and Topotecan side-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.
详细描述
The usual approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Chemotherapy on Topotecan capsule, it will try to look for the relationship between the Topotecan therapeutic efficacy and the Topoisomerase I SNP Genotyping, and the relationship between the Topotecan therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
The study approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Chemotherapy on China Import Topotecan Capsule, it will try to look for the relationship between the Topotecan therapeutic efficacy and the Topoisomerase I SNP Genotyping, and the relationship between the Topotecan therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
- Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind SCLC patients.
- Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind SCLC patients.
- Calculate drug target gene SNPs in all 600 recruited double blind SCLC patients.
- Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.
- Correlate everyone patient drug target gene SNP to everyone patient drug safety.
- Mutually compare the usual approach group SNPs (300 double blind random group separated SCLC patients) with the study approach group SNPs (300 double blind random group separated SCLC patients).
- Confirm the relationship between drug target gene SNPs and drug efficacy.
- Confirm the relationship between drug target gene SNPs and drug safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
No-placebo and random and double blind
入排标准
- 年龄范围
- 24 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Clinical diagnosis of Small Cell Lung Cancer (SCLC)
- •2. Clinical lung tissue biopsy diagnosis of SCLC
- •3. Suitable for enough lung tissue biopsy of SCLC
- •4. Random and double blind
- •5. Measurable disease
- •6. Adequate organ functions
- •7. Adequate performance status
- •8. Age 24 years old and over
- •9. Sign an informed consent form
- •10. Receive blood-drawing
排除标准
- •1. Pneumonectomy
- •2. Treatment with other anti-cancer therapies and cannot be stopped currently
- •3. Pregnancy
- •4. Breast-feeding
- •5. The patients with other serious intercurrent illness or infectious diseases
- •6. Have more than one different kind of cancer at the same time
- •7. Serious Allergy to Drugs
- •8. Clot or Bleed Tendency
- •9. Serious Risks or Serious Adverse Events of the drug product
- •10. The prohibition of drug products
- •11. Have no therapeutic effects
- •12. Follow up to the most current label
研究组 & 干预措施
Topotecan - usual
- Topotecan Capsule
- Chemotherapy
- Topotecan Capsule
- Usual Approach Group
干预措施: Topotecan - usual (Drug)
Topotecan - study
- China Import Topotecan Capsule
- Chemotherapy
- China Import Topotecan Capsule
- Study Approach Group
干预措施: Topotecan - study (Drug)
结局指标
主要结局
Find Topotecan Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
时间窗: Duration up to 14 weeks
1. Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on Topotecan Capsule after lung tissue biopsy, like as the usual approach group. 2. Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on China Import Topotecan Capsule after lung tissue biopsy, like as the study approach group. 3. Assay above every SCLC patient-specific Topotecan drug target (Topoisomerase I) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. 4. Assay above every SCLC patient-specific Topotecan drug target (CYP4503A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.
次要结局
未报告次要终点
研究者
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, IORG Director, Medical Monitor, Safety Officer, IRB Chair
Medicine Invention Design, Inc