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Retrospect Stage IND EXEMPT Clinical Study - Etoposide and Single Nucleotide Polymorphisms

Information source: Medicine Invention Design, Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Small Cell Lung Cancer

Intervention: ETOPOSIDE INJECTION (Drug); CISPLATIN INJECTION (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Dr. Han Xu, President/CEO / PD / PI / Monitor / IRB Chair

Official(s) and/or principal investigator(s):
HAN XU, M.D., Ph.D., Principal Investigator, Affiliation: Medicine Invention Design, Inc
HAN XU, M.D., Ph.D., Study Director, Affiliation: Medicine Invention Design, Inc
HAN XU, M.D. / Ph.D., Study Chair, Affiliation: Medicine Invention Design, Inc
HAN XU, M.D. / Ph.D., Principal Investigator, Affiliation: MIDI Clinical Trial Site Type 1 - Physicians assigned by CRO
HAN XU, M.D. / Ph.D., Principal Investigator, Affiliation: MIDI Clinical Trial Site Type 2 - Investigators assigned by CRO
HAN XU, M.D. / Ph.D., Principal Investigator, Affiliation: MIDI Clinical Trial Site Type 3 - Laboratories assigned by CRO

Summary

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 >

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Find Etoposide Drug Targets' SNP Genotypes which are effectiveness-associated and which are risk-associated.

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

Minimum age: 22 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Medicine Invention Design Incorporation (MIDI), Gaithersburg, Maryland 20877, United States

MIDI Clinical Trial Site Type 1 -c/o- Dr. Han Xu - Physicians assigned by CRO, Gaithersburg, Maryland 20877, United States

MIDI Clinical Trial Site Type 2 -c/o- Dr. Han Xu - Investigators assigned by CRO, Gaithersburg, Maryland 20877, United States

MIDI Clinical Trial Site Type 3 -c/o- Dr. Han Xu - Laboratories assigned by CRO, Gaithersburg, Maryland 20877, United States

Additional Information

FWA < 00015357 > < Medicine Invention Design Incorporation (MIDI) >

IRB < 00009424 > < Medicine Invention Design Incorporation (MIDI) >

IORG < 0007849 > < Medicine Invention Design Incorporation (MIDI) >

NCI Oncology Chemotherapy For Small Cell Lung Cancer (SCLC)

Starting date: July 2010
Last updated: July 13, 2014

Page last updated: August 23, 2015

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