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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: Completed Phase 1 study of Neoplasm Metastasis and Carcinoma, sponsored by Anza Therapeutics.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Neoplasm Metastasis Carcinoma Liver Neoplasms

Interventions

  • DRUG CRS-100

Study Locations (2)

Maryland

  • Johns Hopkins University - Baltimore

Texas

  • Mary Crowley Medical Research Center - Dallas

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2006-10
Phase Phase 1
Anza Therapeutics

3 total trials

What the finished NCT00327652 record still lists

NCT00327652 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 416-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (98% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Neoplasm Metastasis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00327652's enrollment target sits among peer trials

9 41st of 41 higher than 1 of 41 other Neoplasm Metastasis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Neoplasm Metastasis 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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Related registry views

Source: ClinicalTrials.gov NCT00327652, the US trial registry maintained by the National Library of Medicine. NCT00327652 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.