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NCT00327652 · ClinicalTrials.gov registry record · Phase 1
Study of Safety and Tolerability of Intravenous CRS-100 in Adults With Carcinoma and Liver Metastases
A Phase 1 study of Neoplasm Metastasis and Carcinoma, sponsored by Anza Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 2
- Study locations
NCT00327652 is a Phase 1 study of Neoplasm Metastasis and Carcinoma that has completed, run by Anza Therapeutics. The registered enrollment target is 9 participants, below the 416-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT00327652, a Phase 1 study of Neoplasm Metastasis and Carcinoma, has completed, sponsored by Anza Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 2
- Study locations
Study Summary
This clinical trial evaluated the safety and tolerability of CRS-100, an investigational agent containing a live-attenuated strain of Listeria monocytogenes (Lm). CRS-100 is attenuated by genetic modification to limit cell to cell spread and invasion of liver cells. These attenuations result in decreased virulence of CRS-100 in mice but retain the ability of the investigational agent to stimulate immunity in test animals and generate anti-tumor activity in mice. The primary objective of this study was to determine the maximum tolerated dose (MTD) and to explore the safety profile of a single intravenous dose of CRS-100 in consenting volunteers. Immunological response to CRS-100 and tumor status of study participants were also measured. Participation in this first clinical trial with CRS-100 was restricted to adults with carcinoma refractory to standard treatment (or for whom no standard treatment is available) and who additionally had liver metastases.
Conditions Studied
Interventions
- DRUG CRS-100
Study Locations (2)
Maryland
- Johns Hopkins University - Baltimore
Texas
- Mary Crowley Medical Research Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2006-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00327652
The ClinicalTrials.gov registry entry for NCT00327652 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 416-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (98% lower). The listed sponsor is Anza Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Neoplasm Metastasis appearing as the primary indexed condition, and to 1 intervention - of which CRS-100 is the first listed.
NCT00327652 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Maryland, Texas.
Frequently Asked Questions
What is clinical trial NCT00327652 about?
NCT00327652 is a clinical study titled "Study of Safety and Tolerability of Intravenous CRS-100 in Adults With Carcinoma and Liver Metastases". This clinical trial evaluated the safety and tolerability of CRS-100, an investigational agent containing a live-attenuated strain of Listeria monocytogenes (Lm). CRS-100 is attenuated by genetic modification to limit cell to cell spread and invasion of liver cells. These attenuations result in decr...
What is the current status of trial NCT00327652?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2006-10.
What conditions does trial NCT00327652 study?
This clinical trial studies the following conditions: Neoplasm Metastasis, Carcinoma, Liver Neoplasms.
What interventions are being tested in trial NCT00327652?
The interventions under investigation include: CRS-100 (DRUG).
Who is sponsoring clinical trial NCT00327652?
This trial is sponsored by Anza Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00327652 being conducted?
This trial has 2 study locations across Maryland, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.