Drugs-SNPs: Discovery Stage IND EXEMPT SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Detailed Description
The usual approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Injection plus Methotrexate Injection plus Topotecan Injection, it will try to look for the relationship between the ETOPOSIDE therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE 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 Combined Chemotherapy on Etoposide Capsule plus Methotrexate Tablet plus HYCAMTIN - Topotecan Capsule, it will try to look for the relationship between the ETOPOSIDE therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
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- Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind SCLC patients.
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- Mutually compare everyone patient drug target whole gene precision sequence for total 600 recruited double blind SCLC patients.
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- Calculate drug target gene SNPs in all 600 recruited double blind SCLC patients.
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- Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.
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- Correlate everyone patient drug target gene SNP to everyone patient drug safety.
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- 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).
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- Confirm the relationship between drug target gene SNPs and drug efficacy.
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- Confirm the relationship between drug target gene SNPs and drug safety.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: ETOPOSIDE - Usual Etoposide Injection Combined Chemotherapy Etoposide Injection + Methotrexate Injection + Topotecan Injection Usual Approach Group |
Drug: ETOPOSIDE - Usual
Etoposide Injection plus Methotrexate Injection plus Topotecan Injection
Other Names:
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Experimental: ETOPOSIDE - Study Etoposide Capsule Combined Chemotherapy Etoposide Capsule + Methotrexate Tablet + HYCAMTIN - Topotecan Capsule Study Approach Group |
Drug: ETOPOSIDE - Study
Etoposide Capsule plus Methotrexate Tablet plus HYCAMTIN - Topotecan Capsule
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Find Etoposide Drug Targets' SNP Genotypes which are effectiveness-associated and which are risk-associated. [Duration at least 180 days]
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. 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. 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 Oxford precisely sequencing. 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.
Eligibility Criteria
Criteria
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Select 600 Small Cell Lung Cancer Patients who are suitable for lung tissue biopsy
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Duration at least 180 days
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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.
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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:
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- Clinical diagnosis of Small Cell Lung Cancer (SCLC)
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- Clinical lung tissue biopsy diagnosis of SCLC
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- Suitable for enough lung tissue biopsy of SCLC
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- Random and double blind
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- Measurable disease
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- Adequate organ functions
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7 .Adequate performance status
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- Age 22 years old and over
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- Sign an informed consent form
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- Receive blood-drawing
The exclusion criteria:
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- Pneumonectomy
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- Treatment with other anti-cancer therapies and cannot be stopped currently
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- Pregnancy
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- Breast-feeding
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- The patients with other serious inter-current illness or infectious diseases
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- Have more than one different kind of cancer in the same time
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- Serious Allergy to Drugs
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- Serious Bleed Tendency
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- Serious Risks or Serious Adverse Events of the drug product
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- The prohibition of the drug product
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- Have no therapeutic effects
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- Follow up to the most current label
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Medicine Invention Design, Inc. (MIDI) - IORG0007849 | North Bethesda | Maryland | United States | 20852 |
Sponsors and Collaborators
- Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair
- PPD
Investigators
- Principal Investigator: HAN XU, M.D., Ph.D., Medicine Invention Design, Inc. (MIDI) - IORG0007849
- Study Director: HAN XU, M.D., Ph.D., Medicine Invention Design, Inc. (MIDI) - IORG0007849
- Study Chair: HAN XU, M.D. / Ph.D., Medicine Invention Design, Inc. (MIDI) - IORG0007849
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- FWA < 00015357 > < Medicine Invention Design Incorporation (MIDI) >
- IRB < 00009424 > < Medicine Invention Design Incorporation (MIDI) >
- IORG < 0007849 > < Medicine Invention Design Incorporation (MIDI) >
Publications
None provided.- NDA214570
- FWA00015357
- NPI - 1831468511
- NPI - 1023387701
- IRB00009424
- IORG0007849
- NDA214570
- IND78420