Pharmacogenomics IND EXEMPT SNP Clinical Study – Etoposide and Single Nucleotide Polymorphisms

Overview

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.

Full Title of Study: “Explore the Relationship Between Single Nucleotide Polymorphisms and Etoposide Response and Toxicity in Patients With Small Cell Lung Cancer.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 18, 2024

Detailed Description

The usual approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Injection, 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 Combined 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. – 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.

Interventions

  • Drug: ETOPOSIDE – Usual
    • Etoposide Injection
  • Drug: ETOPOSIDE – Study
    • Etoposide Capsule

Arms, Groups and Cohorts

  • Experimental: ETOPOSIDE – Usual
    • Etoposide Injection Chemotherapy Etoposide Injection Usual Approach Group
  • Experimental: ETOPOSIDE – Study
    • Etoposide Capsule Chemotherapy Etoposide Capsule Study Approach Group

Clinical Trial Outcome Measures

Primary Measures

  • Find Etoposide Drug Targets’ SNP Genotypes which are effectiveness-associated, and which are risk-associated.
    • Time Frame: Duration at least 90 days
    • Recruit 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Injection after lung tissue biopsy, like as the usual approach group. Recruit 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Capsule after lung tissue biopsy, like as the study approach group. Assay above every SCLC patient-specific Etoposide (VP-16) drug target (Topoisomerase II) SNP genotype in his or her SCLC cell whole genome DNA with Oxford precisely sequencing. 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.

Participating in This Clinical Trial

  • 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 Combined Chemotherapy on Etoposide Injection 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 Combined Chemotherapy on 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 22 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. Serious 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

    Gender Eligibility: All

    Minimum Age: 22 Years

    Maximum Age: 75 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
    • Collaborator
      • UnitedHealthcare
    • Provider of Information About this Clinical Study
      • Sponsor-Investigator: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, M.D., Ph.D., Sponsor-Investigator, Medical Director, Medical Monitor, Safety Officer, IRB Chair – Medicine Invention Design, Inc
    • Overall Official(s)
      • 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

    Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

    At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.