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NCT01628640 · ClinicalTrials.gov registry record · Phase 1
Viral Therapy in Treating Patient With Refractory Liver Cancer or Advanced Solid Tumors
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01628640: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT01628640 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01628640, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
This phase I trial studies the best dose and side effects of recombinant vesicular stomatitis virus expressing interferon beta in treating patients with liver cancer or solid tumors with lesions that have spread to other parts of the body and do not respond to treatment. The study virus has a gene inserted into it which will allow production of interferon beta, which is a substance that will restrict the spread of the virus to tumor cells and not healthy cells. It will also have some independent anti-cancer activity. Although the primary goal of this study is to evaluate the safety of delivery of this viral agent to people, patients may benefit clinically by having shrinkage or stabilization of their tumor or reduction in their cancer related symptoms (e.g., pain). Funding Source - FDA OOPD.
Primary Outcome
Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population (overall, by dose level, and by disease type). Examined in an exploratory and hypothesis-generating fashion.
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Pharmacological Study
- BIOLOGICAL Recombinant Vesicular Stomatitis Virus-expressing Interferon-beta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2012-08-03 |
| Est. Completion | 2019-04-19 |
| Phase | Phase 1 |
What the finished NCT01628640 record still lists
NCT01628640 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01628640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01628640 about?
NCT01628640 is a clinical study titled "Viral Therapy in Treating Patient With Refractory Liver Cancer or Advanced Solid Tumors". This phase I trial studies the best dose and side effects of recombinant vesicular stomatitis virus expressing interferon beta in treating patients with liver cancer or solid tumors with lesions that have spread to other parts of the body and do not respond to treatment. The study virus has a gene i...
What is the current status of trial NCT01628640?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2012-08-03. Estimated completion is 2019-04-19.
What interventions are being tested in trial NCT01628640?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Pharmacological Study (OTHER), Recombinant Vesicular Stomatitis Virus-expressing Interferon-beta (BIOLOGICAL).
Who is sponsoring clinical trial NCT01628640?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01628640's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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