Drugs-SNPs: Discovery Stage IND EXEMPT SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms

Sponsor
Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT01064466
Collaborator
PPD (Industry)
600
Enrollment
1
Location
2
Arms
71
Anticipated Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: ETOPOSIDE - Usual
  • Drug: ETOPOSIDE - Study
Phase 3

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 plus Methotrexate Injection plus Topotecan 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 plus Methotrexate Tablet plus HYCAMTIN - Topotecan 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.
    1. Mutually compare everyone patient drug target whole gene precision sequence for total 600 recruited double blind SCLC patients.
    1. Calculate drug target gene SNPs in all 600 recruited double blind SCLC patients.
    1. Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.
    1. Correlate everyone patient drug target gene SNP to everyone patient drug safety.
    1. 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).
    1. Confirm the relationship between drug target gene SNPs and drug efficacy.
    1. Confirm the relationship between drug target gene SNPs and drug safety.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Explore the Relationship Between Single Nucleotide Polymorphisms and Etoposide Response and Toxicity in Patients With Small Cell Lung Cancer.
Actual Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: ETOPOSIDE - Usual

Etoposide Injection Combined Chemotherapy Etoposide Injection + Methotrexate Injection + Topotecan Injection Usual Approach Group

Drug: ETOPOSIDE - Usual
Etoposide Injection plus Methotrexate Injection plus Topotecan Injection
Other Names:
  • Etoposide Injection Combined Chemotherapy
  • Experimental: ETOPOSIDE - Study

    Etoposide Capsule Combined Chemotherapy Etoposide Capsule + Methotrexate Tablet + HYCAMTIN - Topotecan Capsule Study Approach Group

    Drug: ETOPOSIDE - Study
    Etoposide Capsule plus Methotrexate Tablet plus HYCAMTIN - Topotecan Capsule
    Other Names:
  • Etoposide Capsule Combined Chemotherapy
  • Outcome Measures

    Primary Outcome Measures

    1. Find Etoposide Drug Targets' SNP Genotypes which are effectiveness-associated and which are risk-associated. [Duration at least 180 days]

      Recruit 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Injection plus Methotrexate Injection plus Topotecan 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 plus Methotrexate Tablet plus HYCAMTIN - Topotecan 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • Select 600 Small Cell Lung Cancer Patients who are suitable for lung tissue biopsy

    • Duration at least 180 days

    • The usual approach group - Recruit 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Injection plus Methotrexate Injection plus Topotecan 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 plus Methotrexate Tablet plus HYCAMTIN - Topotecan Capsule after lung tissue biopsy, like as the study approach group.

    The inclusion criteria:
      1. Clinical diagnosis of Small Cell Lung Cancer (SCLC)
      1. Clinical lung tissue biopsy diagnosis of SCLC
      1. Suitable for enough lung tissue biopsy of SCLC
      1. Random and double blind
      1. Measurable disease
      1. Adequate organ functions
    • 7 .Adequate performance status

      1. Age 22 years old and over
      1. Sign an informed consent form
      1. Receive blood-drawing
    The exclusion criteria:
      1. Pneumonectomy
      1. Treatment with other anti-cancer therapies and cannot be stopped currently
      1. Pregnancy
      1. Breast-feeding
      1. The patients with other serious inter-current illness or infectious diseases
      1. Have more than one different kind of cancer in the same time
      1. Serious Allergy to Drugs
      1. Serious Bleed Tendency
      1. Serious Risks or Serious Adverse Events of the drug product
      1. The prohibition of the drug product
      1. Have no therapeutic effects
      1. Follow up to the most current label

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Medicine Invention Design, Inc. (MIDI) - IORG0007849North BethesdaMarylandUnited States20852

    Sponsors and Collaborators

    • Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair
    • PPD

    Investigators

    • Principal Investigator: HAN XU, M.D., Ph.D., Medicine Invention Design, Inc. (MIDI) - IORG0007849
    • Study Director: HAN XU, M.D., Ph.D., Medicine Invention Design, Inc. (MIDI) - IORG0007849
    • Study Chair: HAN XU, M.D. / Ph.D., Medicine Invention Design, Inc. (MIDI) - IORG0007849

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair, M.D., Ph.D., Sponsor-Investigator, IORG Director, Medical Monitor, Safety Officer, IRB Chair, Medicine Invention Design, Inc
    ClinicalTrials.gov Identifier:
    NCT01064466
    Other Study ID Numbers:
    • NDA214570
    • FWA00015357
    • NPI - 1831468511
    • NPI - 1023387701
    • IRB00009424
    • IORG0007849
    • NDA214570
    • IND78420
    First Posted:
    Feb 8, 2010
    Last Update Posted:
    Sep 1, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair, M.D., Ph.D., Sponsor-Investigator, IORG Director, Medical Monitor, Safety Officer, IRB Chair, Medicine Invention Design, Inc
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 1, 2021