Pharmacogenomics IND EXEMPT SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms (Drugs-SNPs)

January 4, 2024 updated by: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Explore the Relationship Between Single Nucleotide Polymorphisms and Etoposide Response and Toxicity in Patients With Small Cell Lung Cancer.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ETOPOSIDE - Usual
  • Etoposide Injection
  • Chemotherapy
  • Etoposide Injection
  • Usual Approach Group
Drug: ETOPOSIDE - Usual
Etoposide Injection
Other Names:
  • Etoposide Injection Chemotherapy
Experimental: ETOPOSIDE - Study
  • Etoposide Capsule
  • Chemotherapy
  • Etoposide Capsule
  • Study Approach Group
Drug: ETOPOSIDE - Study
Etoposide Capsule
Other Names:
  • Etoposide Capsule Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Find Etoposide Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
Time Frame: Duration at least 90 days
  1. 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.
  2. 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.
  3. 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.
  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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

UnitedHealthcare

Investigators

  • 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: HAN XU, MD/PhD/FAPCR, Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Estimated)

November 18, 2024

Study Completion (Estimated)

December 28, 2024

Study Registration Dates

First Submitted

February 2, 2010

First Submitted That Met QC Criteria

February 4, 2010

First Posted (Estimated)

February 8, 2010

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IND 78,420 to be IND EXEMPT
  • FWA00015357 (Registry Identifier: HHS, Human Protections Administrator)
  • IORG0007849 (Registry Identifier: HHS, IORG)
  • IRB00009424 (Registry Identifier: HHS, IRB)
  • NPI - 1831468511 (Registry Identifier: HHS, Health Care Provider Individual)
  • NPI - 1023387701 (Registry Identifier: HHS, Health Care Provider Organization)
  • IND78420 (Registry Identifier: FDA IND EXEMPT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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