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Drugs-SNPs: Pharmacogenomics IND EXEMPT SNP Clinical Study - Crizotinib and Single Nucleotide Polymorphisms

Sponsor
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06062810
Collaborator
(none)
600
Enrollment
1
Location
2
Arms
14
Anticipated Duration (Months)
42.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Explore the relationship between drug target ALK gene single nucleotide polymorphisms and XALKORI - Crizotinib therapeutic-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.

Explore the relationship between drug target CYP4503A gene single nucleotide polymorphisms and XALKORI - Crizotinib side-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.

Condition or Disease Intervention/Treatment Phase
  • Drug: Crizotinib - Usual
  • Drug: Crizotinib - Study
 Phase 2/Phase 3

Detailed Description

The usual approach group, after lung tissue biopsy, 300 double blind random group separated NSCLC patients currently used the Combined Chemotherapy on XALKORI - crizotinib capsule plus GILOTRIF - afatinib tablet, film coated, it will try to look for the relationship between the Crizotinib therapeutic efficacy and the ALK SNP Genotyping, and the relationship between the Crizotinib therapeutic safety and the CYP4503A SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.

The study approach group, after lung tissue biopsy, 300 double blind random group separated NSCLC patients currently used the Combined Chemotherapy on XALKORI - crizotinib capsule plus GILOTRIF - afatinib tablet, film coated, it will try to look for the relationship between the Crizotinib therapeutic efficacy and the ALK SNP Genotyping, and the relationship between the Crizotinib therapeutic safety and the CYP4503A 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 NSCLC patients.

  2. Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind NSCLC patients.

  3. Calculate drug target gene SNPs in all 600 recruited double blind NSCLC 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 NSCLC patients) with the study approach group SNPs (300 double blind random group separated NSCLC 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 Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The usual approach group (high dose) The study approach group (low dose)The usual approach group (high dose) The study approach group (low dose)
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
No-placebo and random and double blind
Primary Purpose:
Health Services Research
Official Title:
Explore the Relationship Between Single Nucleotide Polymorphisms and Crizotinib Response and Toxicity in Patients With Non-Small Cell Lung Cancer
Anticipated Study Start Date :
Oct 28, 2023
Anticipated Primary Completion Date :
Dec 18, 2024
Anticipated Study Completion Date :
Dec 28, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Crizotinib - Usual

XALKORI - Crizotinib Combined Chemotherapy (high dose) XALKORI - crizotinib capsule + GILOTRIF - afatinib tablet, film coated XALKORI 250 mg taken orally twice daily + GILOTRIF 40 mg orally once daily Usual Approach Group (high dose)

Drug: Crizotinib - Usual
XALKORI - crizotinib capsule plus GILOTRIF - afatinib tablet, film coated (high dose) XALKORI 250 mg taken orally twice daily plus GILOTRIF 40 mg orally once daily
Other Names:
  • Crizotinib Combined Chemotherapy (high dose)

    		•
    Experimental: Crizotinib - Study

    XALKORI - Crizotinib Combined Chemotherapy (low dose) XALKORI - crizotinib capsule + GILOTRIF - afatinib tablet, film coated XALKORI 200 mg taken orally twice daily + GILOTRIF 30 mg orally once daily Usual Approach Group (low dose)

    Drug: Crizotinib - Study
    XALKORI - crizotinib capsule plus GILOTRIF - afatinib tablet, film coated (low dose) XALKORI 200 mg taken orally twice daily plus GILOTRIF 30 mg orally once daily
    Other Names:
  • Crizotinib Combined Chemotherapy (low dose)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Measure and Report Crizotinib oncology drug target ALK SNP Genotypes which are effectiveness-associated. [Up to 12 weeks]

      Recruit 300 double blind random group separated NSCLC patients currently using the Combined Chemotherapy High Dose on XALKORI - crizotinib (250mg orally twice daily) plus GILOTRIF - afatinib (40mg orally once daily), after lung tissue biopsy, to be the usual approach group. Recruit 300 double blind random group separated NSCLC patients currently using the Combined Chemotherapy Low Dose on XALKORI - crizotinib (200mg orally twice daily) plus GILOTRIF - afatinib (30mg orally once daily), after lung tissue biopsy, to be the study approach group. Measure above every NSCLC patient specific Crizotinib oncology drug target ALK SNP genotype in his or her NSCLC cell whole genome DNA with Oxford precisely sequencing. Report every NSCLC patient specific ALK SNP genotype in whole genome DNA sequence.

    2. Measure and Report Crizotinib oncology drug target CYP4503A SNP Genotypes which are risk associated. [Up to 12 weeks]

      Recruit 300 double blind random group separated NSCLC patients currently using the Combined Chemotherapy High Dose on XALKORI - crizotinib (250mg orally twice daily) plus GILOTRIF - afatinib (40mg orally once daily), after lung tissue biopsy, to be the usual approach group. Recruit 300 double blind random group separated NSCLC patients currently using the Combined Chemotherapy Low Dose on XALKORI - crizotinib (200mg orally twice daily) plus GILOTRIF - afatinib (30mg orally once daily), after lung tissue biopsy, to be the study approach group. Measure above every NSCLC patient specific Crizotinib oncology drug target CYP4503A SNP genotype in his/her WBC cell whole genome DNA with Oxford precisely sequencing. Report every NSCLC patient specific CYP4503A SNP genotype in whole genome DNA sequence.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    • Select 600 Non-Small Cell Lung Cancer Patients who are suitable for lung tissue biopsy

    • Dosage Duration at least 90 days

    • The usual approach group - Recruit 300 double blind random group separated NSCLC patients currently used the Combined Chemotherapy High Dose on XALKORI - crizotinib capsule plus GILOTRIF - afatinib tablet, film coated after lung tissue biopsy, like as the usual approach group.

    • The study approach group - Recruit 300 double blind random group separated NSCLC patients currently used the Combined Chemotherapy Low Dose on XALKORI - crizotinib capsule plus GILOTRIF - afatinib tablet, film coated after lung tissue biopsy, like as the study approach group.

    Inclusion Criteria:

    1. Clinical diagnosis of Non-Small Cell Lung Cancer (NSCLC)

    2. Clinical lung tissue biopsy diagnosis of NSCLC

    3. Suitable for enough lung tissue biopsy of NSCLC

    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

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medicine Invention Design, Inc. - IORG0007849 Rockville Maryland United States 20853

    Sponsors and Collaborators

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

    Investigators

    • Study Chair: Han Xu, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849
    • Study Director: Han Xu, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849
    • Principal Investigator: Han Xu, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, Medical Monitor, Safety Officer, IORG Director, IRB Chair, Medicine Invention Design, Inc
    ClinicalTrials.gov Identifier:
    NCT06062810
    Other Study ID Numbers:
    • IND 168463 to be IND EXEMPT
    • FWA00015357
    • IRB00009424
    • IORG0007849
    • NPI - 1831468511
    • NPI - 1023387701
    • IND 168463
    First Posted:
    Oct 2, 2023
    Last Update Posted:
    Oct 9, 2023
    Last Verified:
    Oct 1, 2023
    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., FAPCR, Sponsor-Investigator, IRB Chair, M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, Medical Monitor, Safety Officer, IORG Director, IRB Chair, Medicine Invention Design, Inc
    ALK
    ROS1
    EGFR
    SNP
    Pharmacogenomics
    Gene
    Genetics
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Crizotinib

    Study Results

    No Results Posted as of Oct 9, 2023