Pharmacogenomics ANDA SNP Clinical Study - Topotecan and Single Nucleotide Polymorphisms (Drug-SNP)

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

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: SCLC

Treatments: Drug: Topotecan - study; Drug: Topotecan - usual

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07145333

NPI-1831468511 (Registry Identifier)

IRB00009424 (Registry Identifier)

IND 178174 Commercial

FWA00015357 (Registry Identifier)

NPI-1023387701 (Registry Identifier)

IND178174 (Registry Identifier)

IORG0007849 (Registry Identifier)

Details and patient eligibility

About

Explore the relationship between drug target topoisomerase I gene single nucleotide polymorphisms and Topotecan 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 Topotecan side-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.

Full description

The usual approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Chemotherapy on Topotecan capsule, it will try to look for the relationship between the Topotecan therapeutic efficacy and the Topoisomerase I SNP Genotyping, and the relationship between the Topotecan 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 Chemotherapy on China Import Topotecan Capsule, it will try to look for the relationship between the Topotecan therapeutic efficacy and the Topoisomerase I SNP Genotyping, and the relationship between the Topotecan 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 24 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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 Chemotherapy on Topotecan Capsule 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 Chemotherapy on China Import Topotecan Capsule after lung tissue biopsy, like as the study approach group.

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 24 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. Clot or 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups

Topotecan - usual

Experimental group

Description:

* Topotecan Capsule * Chemotherapy * Topotecan Capsule * Usual Approach Group

Treatment:

Drug: Topotecan - usual

Topotecan - study

Experimental group

Description:

* China Import Topotecan Capsule * Chemotherapy * China Import Topotecan Capsule * Study Approach Group

Treatment:

Drug: Topotecan - study