Ignite Creation Date:
2024-05-06 @ 7:21 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05987956
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-07-29
Brief Title:
Pharmacogenomics IND EXEMPT SNP Clinical Study - Alectinib and Single Nucleotide Polymorphisms
Sponsor:
Han Xu MD PhD FAPCR Sponsor-Investigator IRB Chair
Organization:
Medicine Invention Design Inc
Study Overview
Official Title:
Explore the Relationship Between Single Nucleotide Polymorphisms and Alectinib Response and Toxicity in Patients With Non-Small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Drugs-SNPs
Brief 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
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
Detailed Description:
The usual approach group after biopsy diagnosis 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 biopsy diagnosis 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
The study approach group after biopsy diagnosis 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IND 168453 | REGISTRY | FDA IND EXEMPT | None |
| FWA00015357 | REGISTRY | None | None |
| NPI - 1831468511 | REGISTRY | None | None |
| NPI - 1023387701 | REGISTRY | None | None |
| IRB00009424 | REGISTRY | None | None |
| IORG0007849 | REGISTRY | None | None |