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NCT01636284 · ClinicalTrials.gov registry record · Phase 2
A Phase 2a Study of Modified Vaccinia Virus to Treat Sorafenib-naïve Advanced Liver Cancer
A Phase 2 study, sponsored by Jennerex Biotherapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT01636284: Completed Phase 2 study, sponsored by Jennerex Biotherapeutics.
NCT01636284 is a Phase 2 study that has completed, run by Jennerex Biotherapeutics. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01636284, a Phase 2 study, has completed, sponsored by Jennerex Biotherapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients with advanced Hepatocellular Carcinoma (HCC) who have not been previously treated with sorafenib, and the safe administration of JX-594 in five weekly IV infusions.
Primary Outcome
Number of Participants with Complete response \[CR\] or partial response \[PR\] per modified Response Evaluation Criteria in Solid Tumors (mRECIST) for target and non-target lesions assessed by enhanced CT scan: CR, disappearance of intratumoral enhancing area; PR, \>=30% decrease in sum of diameters of enhancing area; Radiographic Response = CR + PR
Interventions
- BIOLOGICAL JX-594 recombinant vaccina GM-CSF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
What the finished NCT01636284 record still lists
NCT01636284 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which JX-594 recombinant vaccina GM-CSF is the first listed.
NCT01636284 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01636284 about?
NCT01636284 is a clinical study titled "A Phase 2a Study of Modified Vaccinia Virus to Treat Sorafenib-naïve Advanced Liver Cancer". This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients with advanced Hepatocellular Carcinoma (HCC) who have not been previously treated with sorafenib, and the safe administration of JX-594 in five weekly IV infusions.
What is the current status of trial NCT01636284?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2012-06. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01636284?
The interventions under investigation include: JX-594 recombinant vaccina GM-CSF (BIOLOGICAL).
Who is sponsoring clinical trial NCT01636284?
This trial is sponsored by Jennerex Biotherapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01636284's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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