This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Discovery Stage IND EXEMPT Clinical Study - Etoposide and Single Nucleotide Polymorphisms (Drugs-SNPs)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Han Xu, President/CEO / PD / PI / Monitor / IRB Chair, Medicine Invention Design, Inc
ClinicalTrials.gov Identifier:
NCT01064466
First received: February 2, 2010
Last updated: May 28, 2017
Last verified: May 2017
February 2, 2010
May 28, 2017
August 2016
March 2018   (Final data collection date for primary outcome measure)
Find Etoposide Drug Targets' SNP Genotypes which are effectiveness-associated and which are risk-associated. [ Time Frame: Duration at least 180 days ]
  1. Recruit 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on ETOPOSIDE INJECTION plus CISPLATIN INJECTION after local therapy with surgery, like as the usual approach group.
  2. Recruit 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on ETOPOSIDE INJECTION plus CARBOPLATIN INJECTION after local therapy with surgery, 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 SCLC cell whole genome DNA with 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 precisely sequencing.
Drug Targets SNP Genotyping [ Time Frame: 2 week ]
Complete list of historical versions of study NCT01064466 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Discovery Stage IND EXEMPT Clinical Study - Etoposide and Single Nucleotide Polymorphisms
Personalize Etoposide Chemotherapy Toward Small Cell Lung Cancer (SCLC) With Maximizing Effectiveness and Minimizing Risk Via Assay Single Nucleotide Polymorphisms (SNPs) of Relative Etoposide Targets, Topoisomerase II and CYP4503A4

Personalized or individualize Etoposide (VP-16) chemotherapy targeting the SCLC patient-specific biomarkers (Single Nucleotide Polymorphisms - SNPs of relative etoposide targets, topoisomerase II and CYP4503A4)

Targeted SCLC chemotherapy with Etoposide (VP-16) and patient-specific biomarkers (SNPs)

Individualize or personalize etoposide chemotherapy toward small cell lung cancer (SCLC) with maximizing effectiveness via assay single nucleotide polymorphisms (SNPs) of relative etoposide target - topoisomerase II, and minimizing risk via assay single nucleotide polymorphisms (SNPs) of relative etoposide target - CYP4503A4, based on precisely sequencing drug targets' genes.

The usual approach group, after local therapy with surgery, 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on ETOPOSIDE INJECTION plus CISPLATIN INJECTION, it will try to look for the relationship between the ETOPOSIDE INJECTION therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE INJECTION therapeutic safety and the CYP4503A4 SNP Genotyping, based on precisely sequencing drug targets' genes.

The study approach group, after local therapy with surgery, 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on ETOPOSIDE INJECTION plus CARBOPLATIN INJECTION, it will try to look for the relationship between the ETOPOSIDE INJECTION therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE INJECTION therapeutic safety and the CYP4503A4 SNP Genotyping, based on 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 total 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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Small Cell Lung Cancer
  • Drug: ETOPOSIDE - Usual
    ETOPOSIDE INJECTION plus CISPLATIN INJECTION
    Other Name: ETOPOSIDE generic plus CISPLATIN generic
  • Drug: ETOPOSIDE - Study
    ETOPOSIDE INJECTION plus CARBOPLATIN INJECTION
    Other Name: ETOPOSIDE generic plus CARBOPLATIN generic
  • Experimental: ETOPOSIDE - Usual
    • ETOPOSIDE INJECTION
    • Combined Chemotherapy
    • CISPLATIN INJECTION
    • Usual Approach Group
    Intervention: Drug: ETOPOSIDE - Usual
  • Experimental: ETOPOSIDE - Study
    • ETOPOSIDE INJECTION
    • Combined Chemotherapy
    • CARBOPLATIN INJECTION
    • Study Approach Group
    Intervention: Drug: ETOPOSIDE - Study

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
August 2018
March 2018   (Final data collection date for primary outcome measure)
  • Select 800 Small-Cell Lung Cancer Patients
  • 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 CISPLATIN INJECTION after local therapy with surgery, 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 INJECTION plus CARBOPLATIN INJECTION after local therapy with surgery, like as the study approach group.

The inclusion criteria:

  • 1. Clinical diagnosis of small cell lung cancer
  • 2. Clinical biopsy diagnosis of small cell lung cancer
  • 3. Suitable for local therapy with surgery
  • 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. Treatment with other anti-cancer therapies and cannot be stopped currently
  • 2. Pregnancy
  • 3. Breast-feeding
  • 4. The patients with other serious inter-current illness or infectious diseases
  • 5. Have more than one different kind of cancer in the same time
  • 6. Serious Allergy to Lipids
  • 7. Serious Bleed Tendency
  • 8. The prohibition of the drug product
Sexes Eligible for Study: All
22 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01064466
FWA00015357
FWA00015357 ( Other Identifier: DHHS, OHRP )
NPI - 1831468511 ( Other Identifier: Centers for Medicare & Medicaid Services )
NPI - 1023387701 ( Other Identifier: Centers for Medicare & Medicaid Services )
IRB00009424 ( Registry Identifier: IRB )
IORG0007849 ( Registry Identifier: IORG )
Yes
Not Provided
Plan to Share IPD: No
Dr. Han Xu, President/CEO / PD / PI / Monitor / IRB Chair, Medicine Invention Design, Inc
Dr. Han Xu, President/CEO / PD / PI / Monitor / IRB Chair
Not Provided
Principal Investigator: HAN XU, M.D., Ph.D. Medicine Invention Design, Inc
Study Director: HAN XU, M.D., Ph.D. Medicine Invention Design, Inc
Study Chair: HAN XU, M.D. / Ph.D. Medicine Invention Design, Inc
Principal Investigator: HAN XU, M.D. / Ph.D. MIDI Clinical Trial Site Type 1 - Physicians assigned by CRO
Principal Investigator: HAN XU, M.D. / Ph.D. MIDI Clinical Trial Site Type 2 - Investigators assigned by CRO
Principal Investigator: HAN XU, M.D. / Ph.D. MIDI Clinical Trial Site Type 3 - Laboratories assigned by CRO
Medicine Invention Design, Inc
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP