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NCT00149396 · ClinicalTrials.gov registry record · Phase 1

Safety & Efficacy of NV1020 in Colorectal Cancer Metastatic to the Liver

A Phase 1 study of Colorectal Cancer and Liver Neoplasms, sponsored by MediGene.

Completed
Registry status
Phase 1
Development phase
32
Enrollment target
5
Study locations

NCT00149396 is a Phase 1 study of Colorectal Cancer and Liver Neoplasms that has completed, run by MediGene. The registered enrollment target is 32 participants, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (98% lower). The trial reports 5 study locations across 5 states.

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The verdict

NCT00149396, a Phase 1 study of Colorectal Cancer and Liver Neoplasms, has completed, sponsored by MediGene.

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target
5
Study locations

Study Summary

This study is an open-label study. It has two stages. Stage 1 is a dose escalation phase of the study to determine and evaluate the safety and tolerability of repeated treatments with a genetically engineered herpes simplex virus NV1020 administered locoregionally to the liver. Stage 2 is to evaluate the dose found in Stage 1 to be "optimally tolerated". Stage 2 is to assess the efficacy of the optimally tolerated dose of NV1020 by itself and in combination with second-line chemotherapy. Assignment to Stage 1 or Stage 2 of the study is determined by when the patient enters the study.

Interventions

  • DRUG NV1020

Study Locations (5)

California

  • University of California, San Diego - San Diego

Massachusetts

  • Massachusetts General Hospital - Boston

Pennsylvania

  • University of Pittsburgh Cancer Center - Pittsburgh

Tennessee

  • University of Vanderbilt - Nashville

Texas

  • Mary Crowley Medical Research Center - Dallas

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2004-07
Est. Completion 2008-12
Phase Phase 1

Sponsor

MediGene

3 total trials

What the Registry Record Tells You About NCT00149396

The ClinicalTrials.gov registry entry for NCT00149396 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (98% lower). The listed sponsor is MediGene, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which NV1020 is the first listed.

NCT00149396 reports 5 study locations spanning 5 distinct geographic areas - top geographies include California, Massachusetts, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00149396 about?

NCT00149396 is a clinical study titled "Safety & Efficacy of NV1020 in Colorectal Cancer Metastatic to the Liver". This study is an open-label study. It has two stages. Stage 1 is a dose escalation phase of the study to determine and evaluate the safety and tolerability of repeated treatments with a genetically engineered herpes simplex virus NV1020 administered locoregionally to the liver. Stage 2 is to evalua...

What is the current status of trial NCT00149396?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2004-07. Estimated completion is 2008-12.

What conditions does trial NCT00149396 study?

This clinical trial studies the following conditions: Colorectal Cancer, Liver Neoplasms.

What interventions are being tested in trial NCT00149396?

The interventions under investigation include: NV1020 (DRUG).

Who is sponsoring clinical trial NCT00149396?

This trial is sponsored by MediGene, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00149396 being conducted?

This trial has 5 study locations across California, Massachusetts, Pennsylvania, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.