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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05987956
Other study ID # IND 168453 to be IND EXEMPT
Secondary ID FWA00015357NPI -
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date March 8, 2024
Est. completion date December 28, 2024

Study information

Verified date December 2023
Source Medicine Invention Design, Inc
Contact Han Xu, MD/PhD/FAPCR
Phone 301-222-7143
Email hanxumd@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Explore the relationship between drug target ALK gene single nucleotide polymorphisms and ALECENSA - Alectinib therapeutic-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes. Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and ALECENSA - Alectinib side-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.


Description:

The usual approach group, after lung tissue biopsy, 300 double blind random group separated NSCLC patients currently used the Chemotherapy on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, it will try to look for the relationship between the Alectinib therapeutic efficacy and the ALK SNP Genotyping, and the relationship between the Alectinib 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 Chemotherapy on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, it will try to look for the relationship between the Alectinib therapeutic efficacy and the ALK SNP Genotyping, and the relationship between the Alectinib 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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 600
Est. completion date December 28, 2024
Est. primary completion date November 18, 2024
Accepts healthy volunteers No
Gender All
Age group 22 Years to 75 Years
Eligibility - 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 Chemotherapy NDC...01 on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, 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 Chemotherapy NDC...86 on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, 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

Study Design


Intervention

Drug:
Alectinib - Usual
Usual Alectinib Chemotherapy (NDC...01) - ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily
Alectinib - Study
Study Alectinib Chemotherapy (NDC...86) - ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily

Locations

Country Name City State
United States Medicine Invention Design, Inc. - IORG0007849 Rockville Maryland

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated. Recruit 300 double blind random group separated NSCLC patients currently using the Chemotherapy NDC...01 on ALECENSA - alectinib 600 mg orally twice daily, after lung tissue biopsy, to be the usual approach group.
Recruit 300 double blind random group separated NSCLC patients currently using the Chemotherapy NDC...86 on ALECENSA - alectinib 600 mg orally twice daily, after lung tissue biopsy, to be the study approach group.
Measure above every NSCLC patient-specific Alectinib 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.
Measure above every NSCLC patient-specific Alectinib drug target (CYP4503A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.
Report every NSCLC patient-specific CYP4503A4 SNP genotype in whole genome DNA sequence.
Up to 12 weeks
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