Retrospect 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: July 13, 2014
Last verified: July 2014
  Purpose

Personalized 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 and minimizing risk via assay single nucleotide polymorphisms (SNPs) of relative etoposide targets, topoisomerase II and CYP4503A4, based on precisely sequencing drug targets' genes.

< FDA IND 78,420 IND EXEMPT Letter > ---//--- < DHHS OHRP FWA00015357 > ---//--- < IORG0007849 > ---//--- < IRB00009424 >


Condition Intervention Phase
Small Cell Lung Cancer
Drug: ETOPOSIDE INJECTION
Drug: CISPLATIN INJECTION
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Medicine Invention Design, Inc:

Primary Outcome Measures:
  • Find Etoposide Drug Targets' SNP Genotypes which are effectiveness-associated and which are risk-associated. [ Time Frame: Duration at least 180 days ] [ Designated as safety issue: Yes ]
    1. Recruit 400 selected specific SCLC patients who are still surviving currently after at least 2 years used the Combined Chemotherapy on ETOPOSIDE INJECTION plus CISPLATIN INJECTION, like as the usual approach group.
    2. Recruit 400 selected specific SCLC patients who are still surviving currently after at least 2 years used the Single Chemotherapy on ETOPOSIDE INJECTION, 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.


Estimated Enrollment: 800
Study Start Date: July 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ETOPOSIDE
  • ETOPOSIDE INJECTION
  • Single Chemotherapy
  • Study Approach Group
Drug: ETOPOSIDE INJECTION
Generic Oncology Drug approved by USA FDA
Other Name: ETOPOSIDE INJECTION Generic
Experimental: ETOPOSIDE plus CISPLATIN
  • ETOPOSIDE INJECTION plus CISPLATIN INJECTION
  • Combined Chemotherapy
  • Usual Approach Group
Drug: ETOPOSIDE INJECTION
Generic Oncology Drug approved by USA FDA
Other Name: ETOPOSIDE INJECTION Generic
Drug: CISPLATIN INJECTION
Generic Oncology Drug approved by USA FDA
Other Name: CISPLATIN INJECTION Generic

Detailed Description:

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

We obtained the IND 78,420 Exemption Letter from FDA like as Drug Sponsor on 04/29/2009. In future, any IND is not required to conduct our further relative clinical studies. // We obtained DHHS and IRB approval document: Federal-wide Assurance (FWA) for the Protection of Human Subjects for Institutions within the United States (FWA: 00015357). So we can develop our further relative clinical studies in USA.

Our Further Retrospect Clinical Study will use Single Chemotherapy on ETOPOSIDE INJECTION or Combined Chemotherapy on ETOPOSIDE INJECTION plus CISPLATIN INJECTION to treat Small Cell Lung Cancer (SCLC) patients, and 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 treatment option must be ETOPOSIDE INJECTION or ETOPOSIDE INJECTION plus CISPLATIN INJECTION, but the the specific SCLC patients, who had used the ETOPOSIDE INJECTION or the ETOPOSIDE INJECTION plus CISPLATIN INJECTION until right now, have had to survive over 2 years.

According to Etoposide Injection Directions, the Etoposide efficacy target may be Topoisomerase II and the Etoposide metabolism target should be CYP4503A4. // We hope to discover the Topoisomerase II SNP Genotypes which could be more relative to higher therapeutic efficacy, and the CYP4503A4 SNP Genotypes which could be more relative to lower therapeutic risk.

We will assay Single Nucleotide Polymorphisms (SNPs) of Etoposide (VP-16) drug target (Topoisomerase II) which are effectiveness-associated, and will assay Single Nucleotide Polymorphisms (SNPs) of Etoposide (VP-16) drug target (CYP4503A4) which are risk-associated in the specific SCLC patients who are surviving after 2 years used Single Chemotherapy on ETOPOSIDE INJECTION or Combined Chemotherapy on ETOPOSIDE INJECTION plus CISPLATIN INJECTION, based on precisely sequencing drug targets' genes.

In the Retrospect Stage, 400 SCLC patients, used the Combined Chemotherapy on ETOPOSIDE INJECTION plus CISPLATIN INJECTION at all times since 2 years ago until right now, like as the usual approach group. // In the Retrospect Stage, 400 SCLC patients, used the Single Chemotherapy on ETOPOSIDE INJECTION at all times since 2 years ago until right now, like as the study approach group. // In the Retrospect Stage, the usual approach group 400 SCLC patients will continue to be used the Combined Chemotherapy on ETOPOSIDE INJECTION plus CISPLATIN INJECTION. // In the Retrospect Stage, the study approach group 400 SCLC patients will continue to be used the Single Chemotherapy on ETOPOSIDE INJECTION. // All of oncology drugs must be approved by USA FDA and must be sold on USA market legally. // The dosages about all of oncology drugs must abide by their labeling in USA.

We need use the SCLC patients' tissue or humoral specimens to assay the Topoisomerase II SNP Genotypes and the CYP4503A4 SNP Genotypes with precisely sequencing drug targets' genes in USA.

  Eligibility

Ages Eligible for Study:   22 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Select 800 Small-Cell Lung Cancer Patients
  • Duration at least 180 days

The usual approach group - Recruit 400 selected specific SCLC patients who are still surviving currently after at least 2 years used the Combined Chemotherapy on ETOPOSIDE INJECTION plus CISPLATIN INJECTION. (The specific SCLC patients have been used the Combined Chemotherapy on ETOPOSIDE INJECTION plus CISPLATIN INJECTION at all times since at least 2 years ago, and until right now, they are still surviving.)

The study approach group - Recruit 400 selected specific SCLC patients who are still surviving currently after at least 2 years used the Single Chemotherapy on ETOPOSIDE INJECTION. (The specific SCLC patients have been used the Single Chemotherapy on ETOPOSIDE INJECTION at all times since at least 2 years ago, and until right now, they are still surviving.)

The inclusion criteria:

  • 1.Clinical diagnosis of small cell lung cancer
  • 2.Survive more than 2 years after using Single Chemotherapy on ETOPOSIDE INJECTION or Combined Chemotherapy on ETOPOSIDE INJECTION plus CISPLATIN INJECTION
  • 3.Measurable disease
  • 4.Adequate organ functions
  • 5.Adequate performance status
  • 6.Age 22 years old and over
  • 7.Sign an informed consent form
  • 8.Receive biopsy
  • 9.Receive blood-drawing

The exclusion criteria:

  • 1.Pregnancy
  • 2.Breast-feeding
  • 3.The patients with other serious inter-current illness or infectious diseases
  • 4.Have more than one different kind of cancer in the same time
  • 5.Serious Allergy to Lipids
  • 6.Serious Bleed Tendency
  • 7.The prohibition of the drug product
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064466

Locations
United States, Maryland
Medicine Invention Design Incorporation (MIDI)
Gaithersburg, Maryland, United States, 20877
MIDI Clinical Trial Site Type 1 -c/o- Dr. Han Xu - Physicians assigned by CRO
Gaithersburg, Maryland, United States, 20877
MIDI Clinical Trial Site Type 2 -c/o- Dr. Han Xu - Investigators assigned by CRO
Gaithersburg, Maryland, United States, 20877
MIDI Clinical Trial Site Type 3 -c/o- Dr. Han Xu - Laboratories assigned by CRO
Gaithersburg, Maryland, United States, 20877
Sponsors and Collaborators
Dr. Han Xu, President/CEO / PD / PI / Monitor / IRB Chair
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: Dr. Han Xu, President/CEO / PD / PI / Monitor / IRB Chair, Clinical Investigator / Principal Investigator / Program Director / Sponsor / Monitor, Medicine Invention Design, Inc
ClinicalTrials.gov Identifier: NCT01064466     History of Changes
Other Study ID Numbers: FWA00015357, FWA00015357, NPI - 1831468511, NPI - 1023387701, IRB00009424, IORG0007849
Study First Received: February 2, 2010
Last Updated: July 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Etoposide phosphate
Cisplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 24, 2014