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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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2004-07 |
| Est. Completion | 2008-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗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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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.