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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: Completed Phase 1 study of Colorectal Cancer and Liver Neoplasms, sponsored by MediGene.
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 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (98% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Incidence of adverse events for all patients (N=32); Overall incidence ≥20%; Adverse events listed by Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term
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 |
What the finished NCT00149396 record still lists
NCT00149396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (98% lower).
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 lists 5 locations in 5 states (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.
Learn More About Clinical Trials
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Where NCT00149396's enrollment target sits among peer trials
32 318th of 381 higher than 60 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer 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.
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