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Pharmacogenomics IND EXEMPT SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms (Drugs-SNPs)

Primary Purpose

Small Cell Lung Cancer

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ETOPOSIDE - Usual
ETOPOSIDE - Study
Sponsored by
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Small Cell Lung Cancer focused on measuring SCLC, Etoposide, SNP, Topo, CYP, Genotype, Oncology, Genetics, Lung, Cancer

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • Select 600 Small Cell Lung Cancer Patients who are suitable for lung tissue biopsy
  • 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 Tablet plus HYCAMTIN - 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 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:

  • 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 22 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. Serious 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

Sites / Locations

  • Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ETOPOSIDE - Usual

ETOPOSIDE - Study

Arm Description

Etoposide Injection Combined Chemotherapy Etoposide Injection + HYCAMTIN - Topotecan Capsule Usual Approach Group

Etoposide Capsule Combined Chemotherapy Etoposide Capsule + HYCAMTIN - Topotecan Capsule Study Approach Group

Outcomes

Primary Outcome Measures

Find Etoposide Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
Recruit 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Injection plus HYCAMTIN - Topotecan Capsule 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 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.

Secondary Outcome Measures

Full Information

First Posted
February 2, 2010
Last Updated
September 5, 2023
Sponsor
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
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1. Study Identification

Unique Protocol Identification Number
NCT01064466
Brief Title
Pharmacogenomics IND EXEMPT SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms
Acronym
Drugs-SNPs
Official Title
Explore the Relationship Between Single Nucleotide Polymorphisms and Etoposide Response and Toxicity in Patients With Small Cell Lung Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2017 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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 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. 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 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. 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 a total of 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
SCLC, Etoposide, SNP, Topo, CYP, Genotype, Oncology, Genetics, Lung, Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The usual approach group (injection + oral) The study approach group (oral)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
No-placebo and random and double blind
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ETOPOSIDE - Usual
Arm Type
Experimental
Arm Description
Etoposide Injection Combined Chemotherapy Etoposide Injection + HYCAMTIN - Topotecan Capsule Usual Approach Group
Arm Title
ETOPOSIDE - Study
Arm Type
Experimental
Arm Description
Etoposide Capsule Combined Chemotherapy Etoposide Capsule + HYCAMTIN - Topotecan Capsule Study Approach Group
Intervention Type
Drug
Intervention Name(s)
ETOPOSIDE - Usual
Other Intervention Name(s)
Etoposide Injection Combined Chemotherapy
Intervention Description
Etoposide Injection plus HYCAMTIN - Topotecan Capsule
Intervention Type
Drug
Intervention Name(s)
ETOPOSIDE - Study
Other Intervention Name(s)
Etoposide Capsule Combined Chemotherapy
Intervention Description
Etoposide Capsule plus HYCAMTIN - Topotecan Capsule
Primary Outcome Measure Information:
Title
Find Etoposide Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
Description
Recruit 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Injection plus HYCAMTIN - Topotecan Capsule 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 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.
Time Frame
Duration at least 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Combined Chemotherapy on Etoposide Injection plus HYCAMTIN - 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 Combined Chemotherapy on Etoposide Capsule plus HYCAMTIN - Topotecan 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 22 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. Serious 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HAN XU, MD/PhD/FAPCR
Organizational Affiliation
Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
HAN XU, MD/PhD/FAPCR
Organizational Affiliation
Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
HAN XU, MD/PhD/FAPCR
Organizational Affiliation
Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701
Official's Role
Study Chair
Facility Information:
Facility Name
Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20853
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://ohrp.cit.nih.gov/search
Description
FWA < 00015357 > < Medicine Invention Design Incorporation (MIDI) >
URL
http://ohrp.cit.nih.gov/search
Description
IRB < 00009424 > < Medicine Invention Design Incorporation (MIDI) >
URL
http://ohrp.cit.nih.gov/search
Description
IORG < 0007849 > < Medicine Invention Design Incorporation (MIDI) >

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Pharmacogenomics IND EXEMPT SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms

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