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NCT00024661 · ClinicalTrials.gov registry record · Phase 1
Study to Determine the Maximum Tolerated Dose of LErafAON in Patients With Advanced Solid Tumors
A Phase 1 study of Neoplasms, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 3
- Study locations
NCT00024661: Completed Phase 1 study of Neoplasms, sponsored by INSYS Therapeutics.
NCT00024661 is a Phase 1 study of Neoplasms that has completed, run by INSYS Therapeutics. The registered enrollment target is 30 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00024661, a Phase 1 study of Neoplasms, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 3
- Study locations
Study Summary
LErafAON is a liposome encapsulated c-raf antisense oligonucleotide. Raf-1 is a protein produced by human cells, both normal and cancerous, which may help protect tumor cells from radiation. Antisense oligonucleotides are very specific drugs, which can decrease the amount of a certain target protein by blocking the gene that makes it. Antisense oligonucleotide to raf gene can reduce the amount of Raf-1 protein in tumor cells. Liposomes are tiny globules of fat, which can carry drugs in the body. The experimental agent LErafAON is composed of liposomes carrying antisense oligonucleotide against the Raf-1 protein. It is hoped that decreased Raf-1 in the cancer cells will make them more sensitive to the radiation therapy. Patients with advanced solid tumors will receive IV infusions of LErafAON over at least 60 minutes, once per week, for 8 weeks. In the absence of progression, patients may continue on weekly treatment. Pre-medications will be administered prior to each dose of study medication. Cohorts of at least three patients will be entered at escalating dose-levels. Each cohort will be observed for at least ten days after receiving the first dose of treatment before additional patients are treated at a higher dose level. Patients will be followed for one month after receiving the last dose of study medication. The study will stop when a maximum tolerated dose (MTD) is identified. Dose escalation within a patient will not be allowed.
Conditions Studied
Interventions
- DRUG LErafAON
Study Locations (3)
District of Columbia
- Georgetown University - Washington D.C.
Illinois
- University of Chicago Medical Center - Chicago
Pennsylvania
- Temple University Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2001-03 |
| Est. Completion | 2004-10 |
| Phase | Phase 1 |
What the finished NCT00024661 record still lists
NCT00024661 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which LErafAON is the first listed.
NCT00024661 reports a single indexed study location in District of Columbia, Illinois, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00024661 about?
NCT00024661 is a clinical study titled "Study to Determine the Maximum Tolerated Dose of LErafAON in Patients With Advanced Solid Tumors". LErafAON is a liposome encapsulated c-raf antisense oligonucleotide. Raf-1 is a protein produced by human cells, both normal and cancerous, which may help protect tumor cells from radiation. Antisense oligonucleotides are very specific drugs, which can decrease the amount of a certain target protein...
What is the current status of trial NCT00024661?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2001-03. Estimated completion is 2004-10.
What conditions does trial NCT00024661 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT00024661?
The interventions under investigation include: LErafAON (DRUG).
Who is sponsoring clinical trial NCT00024661?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00024661 being conducted?
This trial has 3 study locations across District of Columbia, Illinois, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00024661's enrollment target sits among peer trials
30 134th of 158 higher than 21 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms 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.
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