Pharmacogenomics IND EXEMPT SNP Clinical Study - Alectinib and Single Nucleotide Polymorphisms

Non-small Cell Lung Cancer Clinical Trial

— Drugs-SNPs  

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

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

External Links

•   FWA < 00015357 > < Medicine Invention Design Incorporation (MIDI) >
•   IORG < 0007849 > < Medicine Invention Design Incorporation (MIDI) >
•   IRB < 00009424 > < Medicine Invention Design Incorporation (MIDI) >