Pharmacogenomics ANDA SNP Clinical Study - Topotecan and Single Nucleotide Polymorphisms

Phase 3Active Not RecruitingNCT07145333

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair600 enrolled

Overview

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.

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. 1. Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind SCLC patients. 2. Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind SCLC patients. 3. Calculate drug target gene SNPs in all 600 recruited double blind SCLC patients. 4. Correlate everyone patient drug target gene SNP to everyone patient drug efficacy. 5. Correlate everyone patient drug target gene SNP to everyone patient drug safety. 6. 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). 7. Confirm the relationship between drug target gene SNPs and drug efficacy. 8. Confirm the relationship between drug target gene SNPs and drug safety.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Conditions

SCLC

Interventions

Topotecan - usualDRUG

Topotecan Capsule

Topotecan - studyDRUG

China Import Topotecan Capsule

Eligibility

Sex: ALLMin age: 24 YearsMax age: 64 Years

Medical Language ↔ Plain English

* Select 600 Small Cell Lung Cancer Patients who are suitable for lung tissue biopsy * Dosage Duration at least 45 days * The usual approach group - 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. * The study approach group - 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. Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

Medicine Invention Design Incorporation

Rockville, Maryland, United States

Outcomes

Primary Outcomes

Find Topotecan Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.

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.

Time frame: Duration up to 14 weeks

Data from ClinicalTrials.gov

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