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

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ClinicalTrials.gov Identifier: NCT01064466
Recruitment Status : Active, not recruiting
First Posted : February 8, 2010
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair, Medicine Invention Design, Inc

Brief Summary:

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 Oxford precisely sequencing drug targets' genes.


Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: ETOPOSIDE - Usual Drug: ETOPOSIDE - Study Phase 3

Detailed Description:

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 Methotrexate Injection plus Topotecan 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 Oxford 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 Capsule plus Methotrexate Tablet plus HYCAMTIN - Topotecan Capsule, 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 Oxford 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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 Name: Etoposide Injection Combined Chemotherapy

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 Name: Etoposide Capsule Combined Chemotherapy




Primary Outcome Measures :
  1. 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 Methotrexate Injection plus Topotecan 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 Capsule plus Methotrexate Tablet plus HYCAMTIN - Topotecan Capsule 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 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.



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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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 Methotrexate Injection plus Topotecan 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 Capsule plus Methotrexate Tablet plus HYCAMTIN - Topotecan Capsule 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064466


Locations
United States, Maryland
Medicine Invention Design Incorporation (MIDI) - IORG0007849
Bethesda, Maryland, United States, 20852
MIDI Clinical Trial Site Type 1 -c/o- Dr. Han Xu - Physicians assigned by CRO / IRB / IORG
Bethesda, Maryland, United States, 20852
MIDI Clinical Trial Site Type 2 -c/o- Dr. Han Xu - Investigators assigned by CRO / IRB / IORG
Bethesda, Maryland, United States, 20852
MIDI Clinical Trial Site Type 3 -c/o- Dr. Han Xu - Laboratories assigned by CRO / IRB / IORG
Bethesda, Maryland, United States, 20852
Sponsors and Collaborators
Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair
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
Principal Investigator: HAN XU, M.D. / Ph.D. MIDI Clinical Trial Site Type 1 - Physicians assigned by CRO / IRB / IORG
Principal Investigator: HAN XU, M.D. / Ph.D. MIDI Clinical Trial Site Type 2 - Investigators assigned by CRO / IRB / IORG
Principal Investigator: HAN XU, M.D. / Ph.D. MIDI Clinical Trial Site Type 3 - Laboratories assigned by CRO / IRB / IORG

Additional Information:
Responsible Party: Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair, M.D., Ph.D., Sponsor-Investigator, IORG Director, Medical Monitor, Safety Officer, IRB Chair, Medicine Invention Design, Inc
ClinicalTrials.gov Identifier: NCT01064466     History of Changes
Other Study ID Numbers: 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 )
First Posted: February 8, 2010    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair, Medicine Invention Design, Inc:
SCLC
Etoposide
SNP
Topo
CYP
Genotype
Oncology
Genetics
Lung
Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Methotrexate
Etoposide
Topotecan
Etoposide phosphate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Phytogenic