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NCT00059605 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of IV DOTAP: Cholesterol-Fus1 in Non-Small-Cell Lung Cancer
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT00059605: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00059605 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00059605, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find out the highest safe dose of DOTAP:Chol-fus1 that can be given to participants in the treatment of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC). This study is an attempt to transfer a gene (fus1) into cancer cells, using the drug DOTAP:Cholesterol-fus1. Researchers will also study the side effects of this experimental gene transfer at different doses, and will conduct tests to see if there are any effects on tumor size at different doses. Experimental transfer of the fus1 gene into humans has never been tried before. Objectives: * Assess the toxicity of DOTAP:Cholesterol-fus1 Liposome Complex (DOTAP:Chol-fus1) administered intravenously. * To determine the maximal tolerated dose and recommended phase II dose of DOTAP:Chol-fus1 administered intravenously. * Assess the expression of fus1 following intravenous delivery of DOTAP:Chol-fus1 in tumor and normal bronchial epithelial cell biopsies. * Assess any anti-cancer activity for DOTAP:Chol-fus1.
Interventions
- GENETIC DOTAP:Chol-fus1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2003-03 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
What the finished NCT00059605 record still lists
NCT00059605 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which DOTAP:Chol-fus1 is the first listed.
NCT00059605 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00059605 about?
NCT00059605 is a clinical study titled "Phase I Study of IV DOTAP: Cholesterol-Fus1 in Non-Small-Cell Lung Cancer". The goal of this clinical research study is to find out the highest safe dose of DOTAP:Chol-fus1 that can be given to participants in the treatment of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC). This study is an attempt to transfer a gene (fus1) into cancer cells, using the ...
What is the current status of trial NCT00059605?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2003-03. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00059605?
The interventions under investigation include: DOTAP:Chol-fus1 (GENETIC).
Who is sponsoring clinical trial NCT00059605?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00059605's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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