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Trial Title:
Pharmacogenomics IND EXEMPT SNP Clinical Study - Crizotinib and Single Nucleotide Polymorphisms
NCT ID:
NCT06062810
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Crizotinib
Conditions: Keywords:
ALK
ROS1
EGFR
SNP
Pharmacogenomics
Gene
Genetics
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
- The usual approach group (high dose)
- The study approach group (low dose)
Primary purpose:
Health Services Research
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
No-placebo and random and double blind
Intervention:
Intervention type:
Drug
Intervention name:
Crizotinib - Usual
Description:
- XALKORI - crizotinib capsule (high dose)
- XALKORI 250 mg taken orally twice daily
Arm group label:
Crizotinib - Usual
Other name:
Crizotinib Chemotherapy (high dose)
Intervention type:
Drug
Intervention name:
Crizotinib - Study
Description:
- XALKORI - crizotinib capsule (low dose)
- XALKORI 200 mg taken orally twice daily
Arm group label:
Crizotinib - Study
Other name:
Crizotinib Chemotherapy (low dose)
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.
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, 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, 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.
Criteria for eligibility:
Criteria:
- 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, 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, 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
Gender:
All
Minimum age:
22 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Medicine Invention Design, Inc. - IORG0007849
Address:
City:
Rockville
Zip:
20853
Country:
United States
Contact:
Last name:
Han Xu, MD/PhD/FAPCR
Phone:
301-222-7143
Email:
hanxumd@gmail.com
Contact backup:
Last name:
Han Xu, MD/PhD/FAPCR
Phone:
301-326-8978
Email:
midinc@hotmail.com
Investigator:
Last name:
Han Xu, MD/PhD/FAPCR
Email:
Principal Investigator
Start date:
March 28, 2024
Completion date:
December 28, 2024
Lead sponsor:
Agency:
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Agency class:
Industry
Source:
Medicine Invention Design, Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06062810
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