Clinical Trials in the USA / NCT01064466
Active, not recruiting
Phase 2/3
Pharmacogenomics ANDA SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms
NCT01064466 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Small Cell Lung Cancer
Investigational drug(s) / intervention(s)
ETOPOSIDE - UsualETOPOSIDE - Study →
ETOPOSIDE - Usual: Etoposide Capsule
ETOPOSIDE - Study: China Import Etoposide Capsule
Study 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.
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 Chemotherapy on Etoposide 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 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 24 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\. 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
Primary outcome measure(s)
- Find Etoposide Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated. — Duration at least 90 days
1. Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on Etoposide Capsule after lung tissue biopsy, like as the usual approach group. 2. Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on China Import Etoposide Capsule after lung tissue biopsy, like as the study approach group. 3. Assay above every SCLC patient-specific Etoposide (VP-16) drug target (Topoisomerase II) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. 4. 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701 | Rockville | Maryland |
More Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair trials in the USA
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT01064466 on ClinicalTrials.gov ↗ ← All trials in the USA