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NCT00585845 · ClinicalTrials.gov registry record · Phase 1
Study of Safety and Tolerability of Intravenous CRS-207 in Adults With Selected Advanced Solid Tumors Who Have Failed or Who Are Not Candidates for Standard Treatment
A Phase 1 study, sponsored by Anza Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT00585845 is a Phase 1 study that was terminated before completion, run by Anza Therapeutics. The registered enrollment target is 17 participants.
The verdict
NCT00585845, a Phase 1 study, was terminated before completion, sponsored by Anza Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
This clinical trial will evaluate the safety and tolerability of CRS 207 an investigational product that is a weakened form (attenuated) of Listeria monocytogenes, a type of bacteria that is commonly found in the environment. CRS-207 has been altered in the lab to reduce its ability to cause disease, while maintaining stimulation of the immune system. CRS 207 has also been genetically modified with recombinant DNA to release an antigen called Mesothelin. Because CRS 207 stimulates an immune response to Mesothelin and Mesothelin may be present at higher levels on tumor cells than on normal cells, this clinical trial will also examine if CRS 207 boosts the immune system in a way that targets certain types of cancer. The purpose of this first clinical trial with CRS-207 is to identify an appropriate dose of the investigation agent for later clinical studies and to explore safety when given to consenting adults with advanced cancer of the ovary or pancreas, non-small cell lung cancer, or advanced malignant epithelial mesothelioma. Immunological response to CRS-207 and tumor status of study participants will also be measured. Patients who choose to enter the study must meet all study entry criteria and must have previously failed standard treatment for their cancer. Qualifying study patients will be assigned to receive one of several dose levels of CRS-207. Each patient may receive up to 4 intravenous administrations (21 days apart) of CRS-207 at their assigned dose level.
Interventions
- BIOLOGICAL CRS-207, Live-attenuated Listeria monocytogenes expressing human Mesothelin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2007-12 |
| Est. Completion | 2009-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00585845
The ClinicalTrials.gov registry entry for NCT00585845 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Anza Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CRS-207, Live-attenuated Listeria monocytogenes expressing human Mesothelin is the first listed.
NCT00585845 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00585845 about?
NCT00585845 is a clinical study titled "Study of Safety and Tolerability of Intravenous CRS-207 in Adults With Selected Advanced Solid Tumors Who Have Failed or Who Are Not Candidates for Standard Treatment". This clinical trial will evaluate the safety and tolerability of CRS 207 an investigational product that is a weakened form (attenuated) of Listeria monocytogenes, a type of bacteria that is commonly found in the environment. CRS-207 has been altered in the lab to reduce its ability to cause disease...
What is the current status of trial NCT00585845?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2007-12. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00585845?
The interventions under investigation include: CRS-207, Live-attenuated Listeria monocytogenes expressing human Mesothelin (BIOLOGICAL).
Who is sponsoring clinical trial NCT00585845?
This trial is sponsored by Anza Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
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