Pharmacogenomics ANDA SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms

NCT01064466 | Active Not Recruiting Phase 2 DMC FDA Drug

• 7 other identifiers: IND 178172 CommercialFWA00015357NPI - 1831468511NPI - 1023387701IRB00009424IORG0007849IND 178172
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Small Cell Lung Cancer

Keywords

SCLC; Etoposide; SNP; Topo; CYP; Genotype; Oncology; Genetics; Lung; Cancer

Outcome Measures

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.

  Duration at least 90 days

Study Arms (2)

ETOPOSIDE - Usual

EXPERIMENTAL

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

Drug: ETOPOSIDE - Usual

ETOPOSIDE - Study

EXPERIMENTAL

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

Drug: ETOPOSIDE - Study

Interventions

ETOPOSIDE - Usual DRUG

Etoposide Capsule

Also known as: Usual Etoposide Capsule Chemotherapy

ETOPOSIDE - Usual

ETOPOSIDE - Study DRUG

China Import Etoposide Capsule

Also known as: Study Etoposide Capsule Chemotherapy

ETOPOSIDE - Study

Eligibility Criteria

• Age: 24 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Clinical diagnosis of Small Cell Lung Cancer (SCLC)
• \. Clinical lung tissue biopsy diagnosis of SCLC
• \. Suitable for enough lung tissue biopsy of SCLC
• \. Random and double blind
• \. Measurable disease
• \. Adequate organ functions
• \. Adequate performance status
• \. Age 24 years old and over
• \. Sign an informed consent form
• \. Receive blood-drawing

You may not qualify if:

• \. Pneumonectomy
• \. Treatment with other anti-cancer therapies and cannot be stopped currently
• \. Pregnancy
• \. Breast-feeding
• \. The patients with other serious intercurrent illness or infectious diseases
• \. Have more than one different kind of cancer at the same time
• \. Serious Allergy to Drugs
• \. Clot or Bleed Tendency
• \. Serious Risks or Serious Adverse Events of the drug product
• \. The prohibition of drug products
• \. Have no therapeutic effects
• \. Follow up to the most current label

Sponsors & Collaborators

• Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair: lead
• UnitedHealthcare: collaborator

Study Sites (1)

Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701

Rockville, Maryland, 20853, United States

Location

Related Links

• FWA \< 00015357 \> \< Medicine Invention Design Incorporation (MIDI) \>
• IRB \< 00009424 \> \< Medicine Invention Design Incorporation (MIDI) \>
• IORG \< 0007849 \> \< Medicine Invention Design Incorporation (MIDI) \>

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• HAN XU, MD/PhD/FAPCR

  Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701

  PRINCIPAL INVESTIGATOR

• HAN XU, MD/PhD/FAPCR

  Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701

  STUDY DIRECTOR

• HAN XU, MD/PhD/FAPCR

  Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: No-placebo and random and double blind
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Ph.D., Sponsor-Investigator, Medical Director, Medical Monitor, Safety Officer, IRB Chair

Model Details: * The usual approach group (Oral) * The study approach group (Oral) (China Import)

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 8, 2010
• Study Start: July 16, 2025
• Primary Completion (Estimated): November 18, 2026
• Study Completion (Estimated): December 28, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)