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

Small Cell Lung Cancer Clinical Trial

— Drugs-SNPs  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01064466
• Other study ID #: IND 78,420 to be IND EXEMPT
• Secondary ID: FWA00015357NPI -
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: January 2017
• Est. completion date: December 28, 2024

Study information

• Verified date: January 2024
• Source: Medicine Invention Design, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Explore the relationship between drug target topoisomerase II gene single nucleotide polymorphisms and Etoposide (VP-16) therapeutic-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.

Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and Etoposide (VP-16) side-effects in patients with 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 SCLC patients currently used the Combined Chemotherapy on Etoposide Injection, it will try to look for the relationship between the ETOPOSIDE therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.

The study approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Capsule, it will try to look for the relationship between the ETOPOSIDE therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE 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 SCLC patients.

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

• 3) Calculate drug target gene SNPs in all 600 recruited double blind SCLC 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 SCLC patients) with the study approach group SNPs (300 double blind random group separated SCLC 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: Active, not 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 Small Cell Lung Cancer Patients who are suitable for lung tissue biopsy

• Dosage Duration at least 45 days

• The usual approach group - Recruit 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Injection after lung tissue biopsy, like as the usual approach group.

• The study approach group - Recruit 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Capsule after lung tissue biopsy, like as the study approach group.

The inclusion criteria:

• 1. Clinical diagnosis of Small Cell Lung Cancer (SCLC)

• 2. Clinical lung tissue biopsy diagnosis of SCLC

• 3. Suitable for enough lung tissue biopsy of SCLC

• 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

The 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

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• ETOPOSIDE - Usual
Etoposide Injection
• ETOPOSIDE - Study
Etoposide Capsule

Locations

Country	Name	City	State
United States	Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701	Rockville	Maryland

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Find Etoposide Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.	Recruit 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Injection after lung tissue biopsy, like as the usual approach group.; Recruit 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Capsule after lung tissue biopsy, like as the study approach group.; Assay above every SCLC patient-specific Etoposide (VP-16) drug target (Topoisomerase II) SNP genotype in his or her SCLC cell whole genome DNA with Oxford precisely sequencing.; Assay above every SCLC patient-specific Etoposide (VP-16) drug target (CYP4503A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.	Duration at least 90 days

External Links

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