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Pharmacogenomics ANDA SNP Clinical Study - Topotecan and Single Nucleotide Polymorphisms

NCT07145333 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-09-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Topotecan - usual

Topotecan Capsule

DRUG

Topotecan - study

China Import Topotecan Capsule

Sponsors & Collaborators

  • UnitedHealthcare

    collaborator OTHER

  • Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

    lead INDUSTRY

Principal Investigators

  • HAN XU, MD/PhD/FAPCR · Medicine Invention Design, Inc. - IRB00009424 - IORG0007849

  • HAN XU, MD/PhD/FAPCR · Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701

  • HAN ID XU, MD/PhD/FAPCR · Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
24 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-12
Primary Completion
2026-09-18
Completion
2026-10-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07145333 on ClinicalTrials.gov