Pharmacogenomics ANDA SNP Clinical Study - Topotecan and Single Nucleotide Polymorphisms
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.
Checked against the public recordLast updated Sep 8, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Health Services Research
- Study type
- Interventional
- Phase
- Phase 2 / Phase 3
- Sponsor
- Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
- Interventions being studied
- Drug: Topotecan - usual; Drug: Topotecan - study
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
* 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Medicine Invention Design IncorporationRockville, Maryland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 8, 2025. Always confirm current availability with the study team.