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NCT00100672 · ClinicalTrials.gov registry record · Phase 1
Study to Determine the Maximum Tolerated Dose of LErafAON in Patients With Advanced Cancer
A Phase 1 study, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00100672 is a Phase 1 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 40 participants.
The verdict
NCT00100672, a Phase 1 study, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The primary purpose of this study is to identify a dose of Liposome Entrapped c-raf Antisense Oligonucleotide Easy-to-Use (LErafAON-ETU) which maximizes potential benefits of the compound to patients with advanced cancer, without compromising their safety. This study will also assess the processing of LErafAON-ETU by the body over time. Patients will receive an intravenous infusion of LErafAON-ETU each week. Multiple blood samples will be taken for pharmacokinetic analysis during the first treatment; two samples will be taken during both the second and third treatments. Patients will be eligible to continue treatment until the occurrence of unacceptable toxicity or disease progression. In LErafAON-ETU, antisense oligonucleotides specific to c-raf, are associated with liposomes, which are microscopic membrane-like structures created from lipids (fats). Raf-1 is a protein which plays a critical role in many aspects of cellular activation and growth. Therefore, it is thought to be an important factor that may support tumor development. LErafAON-ETU potentially limits the ability of a cell to produce the Raf-1 protein.
Interventions
- DRUG LErafAON-ETU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2004-12 |
| Est. Completion | 2010-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00100672
The ClinicalTrials.gov registry entry for NCT00100672 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is INSYS Therapeutics, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LErafAON-ETU is the first listed.
NCT00100672 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00100672 about?
NCT00100672 is a clinical study titled "Study to Determine the Maximum Tolerated Dose of LErafAON in Patients With Advanced Cancer". The primary purpose of this study is to identify a dose of Liposome Entrapped c-raf Antisense Oligonucleotide Easy-to-Use (LErafAON-ETU) which maximizes potential benefits of the compound to patients with advanced cancer, without compromising their safety. This study will also assess the processing ...
What is the current status of trial NCT00100672?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2004-12. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00100672?
The interventions under investigation include: LErafAON-ETU (DRUG).
Who is sponsoring clinical trial NCT00100672?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
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