Pharmacogenomics ANDA SNP Clinical Study - Topotecan and Single Nucleotide Polymorphisms

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.

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Key things to know

Main goalHealth Services Research

This describes the study’s primary purpose.

What is being studiedTopotecan - usual and Topotecan - study

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 8, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 2 / Phase 3

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair

Study sponsor

Study overview

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, Medical Director, IRB Chair
Interventions being studied: Drug: Topotecan - usual; Drug: Topotecan - study

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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.
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

Reasons someone may not be able to joinExclusion 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.

Study sites

U.S. locations

Medicine Invention Design IncorporationRockville, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 8, 2026. Always confirm current availability with the study team.

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