Discovery Stage IND EXEMPT SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Han Xu, President/CEO / PD / PI / Monitor / IRB Chair; Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair
• Collaborator: PPD
• Treatments: Cisplatin; Etoposide; Etoposide phosphate

Criteria

• Select 600 Small Cell Lung Cancer Patients who are suitable for lung tissue biopsy

• Duration at least 180 days

• The usual approach group - Recruit 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Injection plus Methotrexate Injection plus Topotecan 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 plus Methotrexate Tablet plus HYCAMTIN - Topotecan 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 inter-current illness or infectious diseases

• 6. Have more than one different kind of cancer in 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 the drug product

• 11. Have no therapeutic effects

• 12. Follow up to the most current label