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Topoisomerase I inhibitors
Etoposide for Small Cell Lung Cancer (Drugs-SNPs Trial)
Phase 2 & 3
Waitlist Available
Research Sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis of Small Cell Lung Cancer (SCLC)
Suitable for enough lung tissue biopsy of SCLC
Must not have
Have more than one different kind of cancer at the same time
Serious Bleed Tendency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration at least 90 days
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial uses Etoposide to treat small cell lung cancer patients. It aims to understand how differences in two specific genes affect treatment success and safety. Researchers study these genes to find links between genetic differences and how patients respond to the drug.
Who is the study for?
This trial is for adults over 22 with small cell lung cancer who can undergo a biopsy and have their blood drawn. They must be able to sign consent, have measurable disease, good organ function and performance status. It's not for those with serious allergies to drugs, multiple cancers, severe bleeding risks or infections, pregnant or breastfeeding individuals.
What is being tested?
The study investigates how genetic differences (SNPs) in the topoisomerase II gene and CYP4503A4 gene affect the treatment outcomes and side effects of Etoposide in small cell lung cancer patients. The trial uses precise gene sequencing techniques.
What are the potential side effects?
Etoposide may cause low white blood cell counts (increasing infection risk), hair loss, nausea, vomiting, diarrhea or constipation. There might also be allergic reactions like rashes or more serious ones that could require immediate medical attention.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Small Cell Lung Cancer.
Select...
My doctor can take a biopsy of my lung tissue.
Select...
My lung cancer was confirmed through a tissue biopsy.
Select...
I am 22 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have more than one type of cancer.
Select...
I have a serious tendency to bleed.
Select...
I am aware of the serious risks or side effects of the drug.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration at least 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration at least 90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Find Etoposide Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: ETOPOSIDE - UsualExperimental Treatment1 Intervention
* Etoposide Injection
* Chemotherapy
* Etoposide Injection
* Usual Approach Group
Group II: ETOPOSIDE - StudyExperimental Treatment1 Intervention
* Etoposide Capsule
* Chemotherapy
* Etoposide Capsule
* Study Approach Group
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Etoposide, a topoisomerase II inhibitor, works by inducing DNA strand breaks during replication, leading to cell death, which is particularly effective in rapidly dividing cancer cells. Carboplatin, a platinum-based drug, forms DNA crosslinks that inhibit DNA synthesis and transcription, also resulting in cell death.
These mechanisms are vital for Small Cell Lung Cancer patients due to the disease's rapid growth and early spread, making it highly responsive to treatments targeting DNA replication and repair.
Carboplatin plus etoposide versus topotecan as second-line treatment for patients with sensitive relapsed small-cell lung cancer: an open-label, multicentre, randomised, phase 3 trial.
Carboplatin plus etoposide versus topotecan as second-line treatment for patients with sensitive relapsed small-cell lung cancer: an open-label, multicentre, randomised, phase 3 trial.
Find a Location
Who is running the clinical trial?
UnitedHealthcareOTHER
4 Previous Clinical Trials
593,168 Total Patients Enrolled
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB ChairLead Sponsor
5 Previous Clinical Trials
1,840 Total Patients Enrolled
Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB ChairLead Sponsor
3 Previous Clinical Trials
640 Total Patients Enrolled
HAN XU, MD/PhD/FAPCRStudy ChairMedicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701
2 Previous Clinical Trials
620 Total Patients Enrolled
HAN XU, M.D., Ph.D.Study ChairMedicine Invention Design, Inc. (MIDI) - IORG0007849
3 Previous Clinical Trials
640 Total Patients Enrolled
HAN XU, M.D. / Ph.D.Study ChairMedicine Invention Design, Inc. (MIDI) - IORG0007849
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have more than one type of cancer.I do not have any serious illnesses or infections besides my cancer.I have a serious tendency to bleed.I am aware of the serious risks or side effects of the drug.I have been diagnosed with Small Cell Lung Cancer.I am willing to have my blood drawn for tests.My doctor can take a biopsy of my lung tissue.My lung cancer was confirmed through a tissue biopsy.My organs are working well.I am generally healthy and active.I am 22 years old or older.I have had a lung removed.
Research Study Groups:
This trial has the following groups:- Group 1: ETOPOSIDE - Study
- Group 2: ETOPOSIDE - Usual
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.