Explore the Relationship Between Single Nucleotide Polymorphisms and Alectinib Response and Toxicity in Patients With Non-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
- 3
- 主要终点
- Measure and Report Alectinib 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 ALK gene single nucleotide polymorphisms and ALECENSA - Alectinib therapeutic-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.
Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and ALECENSA - Alectinib side-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.
详细描述
The usual approach group, diagnosed metastatic ALK-positive NSCLC, 300 Sequential Assignment group separated NSCLC patients currently used the Chemotherapy on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, it will try to look for the relationship between the Alectinib therapeutic efficacy and the ALK SNP Genotyping, and the relationship between the Alectinib therapeutic safety and the CYP4503A SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
The study approach group, diagnosed metastatic ALK-positive NSCLC, 300 Sequential Assignment group separated NSCLC patients currently used the Chemotherapy on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, it will try to look for the relationship between the Alectinib therapeutic efficacy and the ALK SNP Genotyping, and the relationship between the Alectinib 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 Sequential Assignment NSCLC patients.
- Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited Sequential Assignment NSCLC patients.
- Calculate drug target gene SNPs in all 600 recruited Sequential Assignment NSCLC 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 Sequential Assignment group separated NSCLC patients) with the study approach group SNPs (300 Sequential Assignment group separated NSCLC 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
- Na
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Open Label
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
- •Select 600 patients with Metastatic ALK-Positive Non-Small Cell Lung Cancer (NSCLC) as follows:
- •Took ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily more than 90 days
- •Had no further NSCLC metastatic or growth in more than previous 90 days
- •Dosage Duration at least 90 days
- •The usual approach group - Recruit 300 Sequential Assignment group separated NSCLC patients currently used the Chemotherapy NDC...01 on ALECENSA capsule 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, like as the usual approach group.
- •The study approach group - Recruit 300 Sequential Assignment group separated NSCLC patients currently used the Chemotherapy NDC...86 on ALECENSA capsule 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, like as the study approach group.
- •Inclusion Criteria:
- •1. Metastatic ALK-Positive Non-Small Cell Lung Cancer (NSCLC) as follows:
- •Took ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily more than 90 days
- •Had no further NSCLC metastatic or growth in more than previous 90 days
- •2. Suitable for enough blood-drawing
- •3. Sequential Assignment
- •4. Measurable disease
- •5. Adequate organ functions
- •6. Adequate performance status
- •7. Age 24-64 years old
- •8. Sign an informed consent form
- •9. 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. Serious 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
Alectinib
- Usual ALECENSA - Alectinib
- Chemotherapy (NDC...01)
- Usual ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily
- Usual Approach Group (NDC...01) (Patient 1-300)
- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily
- Study ALECENSA - Alectinib
- Chemotherapy (NDC...86)
- Study ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily
- Study Approach Group (NDC...86) (Patient 301-600)
- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily
干预措施: Alectinib (Drug)
结局指标
主要结局
Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
时间窗: Up to 12 weeks
* Recruit 300 double blind random group separated NSCLC patients currently using the Chemotherapy NDC...01 on ALECENSA - alectinib 600 mg orally twice daily, after biopsy diagnosis, to be the usual approach group. * Recruit 300 double blind random group separated NSCLC patients currently using the Chemotherapy NDC...86 on ALECENSA - alectinib 600 mg orally twice daily, after biopsy diagnosis, to be the study approach group. * Measure above every NSCLC patient-specific Alectinib drug target (ALK) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. * Report every NSCLC patient-specific ALK SNP genotype in whole genome DNA sequence. * Measure above every NSCLC patient-specific Alectinib drug target (CYP4503A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. * Report every NSCLC patient-specific CYP4503A4 SNP genotype in whole genome DNA sequence.
Measure and Report Alectinib Drug Targets' SNP Genotypes which are risk-associated
时间窗: Up to 12 weeks
* Select 300 Sequential Assignment group separated ALK-Positive Metastatic NSCLC patients currently using the Chemotherapy NDC...01 ALECENSA - alectinib 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, to be the usual approach group. * Select 300 Sequential Assignment group separated ALK-Positive Metastatic NSCLC patients currently using the Chemotherapy NDC...86 ALECENSA - alectinib 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, to be the study approach group. * Measure above every NSCLC patient-specific Alectinib drug target (CYP3A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. * Report every NSCLC patient-specific CYP3A4 SNP genotype in whole genome DNA sequence.
Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated
时间窗: Up to 12 weeks
* Select 300 Sequential Assignment group separated ALK-Positive Metastatic NSCLC patients currently using the Chemotherapy NDC...01 ALECENSA - alectinib 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, to be the usual approach group. * Select 300 Sequential Assignment group separated ALK-Positive Metastatic NSCLC patients currently using the Chemotherapy NDC...86 ALECENSA - alectinib 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, to be the study approach group. * Measure above every NSCLC patient-specific Alectinib drug target (ALK) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. * Report every NSCLC patient-specific ALK SNP genotype in whole genome DNA sequence.
次要结局
未报告次要终点
研究者
Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair
Sponsor, Medical Director, Medical Monitor, Safety Officer, IRB Chair
Medicine Invention Design, Inc