Status:
ACTIVE_NOT_RECRUITING
Pharmacogenomics ANDA SNP Clinical Study - Topotecan and Single Nucleotide Polymorphisms
Lead Sponsor:
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Collaborating Sponsors:
UnitedHealthcare
Conditions:
SCLC
Eligibility:
All Genders
24-64 years
Phase:
PHASE2
PHASE3
Brief Summary
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 s...
Detailed 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...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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
Key Trial Info
Start Date :
August 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 28 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT07145333
Start Date
August 12 2025
End Date
October 28 2026
Last Update
September 8 2025
Active Locations (1)
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1
Medicine Invention Design Incorporation
Rockville, Maryland, United States, 20853