NCT07145333

Pharmacogenomics ANDA SNP Clinical Study - Topotecan and Single Nucleotide Polymorphisms

Explore the Relationship Between Single Nucleotide Polymorphisms and Topotecan Response and Toxicity in Patients With Small Cell Lung Cancer.

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair · Industry
• Sex: All
• Age: 24 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• SCLC

Interventions

Type	Name	Description
DRUG	Topotecan - usual	Topotecan Capsule
DRUG	Topotecan - study	China Import Topotecan Capsule

Timeline

• Start date: 2025-08-12
• Primary completion: 2026-09-18
• Completion: 2026-10-28
• First posted: 2025-08-28
• Last updated: 2025-09-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study