CClinicalTrials.gg
Sign In
Active, not recruitingNCT01064466Drugs-SNPsUpdated Aug 27, 2026

Pharmacogenomics ANDA SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms

A Phase 2/3 interventional study of ETOPOSIDE - Usual and ETOPOSIDE - Study in Small Cell Lung Cancer, sponsored by Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair. Active, not recruiting at 1 site in United States. Open to participants aged 24 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair · Phase 2/3, Interventional, and Health services research

Phase
Phase 2/3
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
24 Years to 64 Years
Sex
All
01

Study summary

Explore the relationship between drug target topoisomerase II gene single nucleotide polymorphisms and Etoposide (VP-16) 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 Etoposide (VP-16) side-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.

Read the detailed description

The usual approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Chemotherapy on ETOPOSIDE capsule, it will try to look for the relationship between the ETOPOSIDE therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE 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 Etoposide Capsule, it will try to look for the relationship between the ETOPOSIDE therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE 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.
02

Conditions studied

  • Small Cell Lung Cancer

Keywords

  • SCLC
  • Etoposide
  • SNP
  • Topo
  • CYP
  • Genotype
  • Oncology
  • Genetics
  • Lung
  • Cancer
03

In context

Small Cell Lung Carcinoma

1,203 studies on the registry are indexed under Small Cell Lung Carcinoma; 342 are open to participants now.

This study's planned enrollment of 600 is above the median of 56 across 1,031 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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 Etoposide 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 Etoposide Capsule after lung tissue biopsy, like as the study approach group.

The 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

The 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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    ETOPOSIDE - Usual

    * Etoposide Capsule * Chemotherapy * Etoposide Capsule * Usual Approach Group

    Drug: ETOPOSIDE - Usual

  • Experimental
    ETOPOSIDE - Study

    * China Import Etoposide Capsule * Chemotherapy * China Import Etoposide Capsule * Study Approach Group

    Drug: ETOPOSIDE - Study

Interventions

  • DrugETOPOSIDE - Usual

    Etoposide Capsule

    Also known as: Usual Etoposide Capsule Chemotherapy

  • DrugETOPOSIDE - Study

    China Import Etoposide Capsule

    Also known as: Study Etoposide Capsule Chemotherapy

06

What researchers measure

Primary outcomes

  1. Find Etoposide 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 Etoposide 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 Etoposide Capsule after lung tissue biopsy, like as the study approach group. 3. Assay above every SCLC patient-specific Etoposide (VP-16) drug target (Topoisomerase II) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. 4. Assay above every SCLC patient-specific Etoposide (VP-16) drug target (CYP4503A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.

    Time frame: Duration at least 90 days

07

Study locations

1 site
  • Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701
    Rockville, Maryland 20853, United States
08

References and documents

Study documents

  • Study protocol · Jul 16, 2025
  • Statistical analysis plan · Jul 16, 2025
  • Informed consent form · Jul 16, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01064466
Lead sponsor
Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair
Collaborators
UnitedHealthcare
Responsible party
Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair (M.D., Ph.D., Sponsor-Investigator, Medical Director, Medical Monitor, Safety Officer, IRB Chair, Medicine Invention Design, Inc) — Sponsor-investigator
First posted
Feb 8, 2010
Start date
Jul 16, 2025
Primary completion
Nov 18, 2026 (estimated)
Completion
Dec 28, 2026 (estimated)
Last update
Aug 27, 2026

Study contacts

HAN XU, MD/PhD/FAPCR
principal investigator · Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701
HAN XU, MD/PhD/FAPCR
study director · Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701
HAN XU, MD/PhD/FAPCR
study chair · Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Small Cell Lung Carcinoma→

Other studies from this sponsor

Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair

Start the discussion