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NCT01309230 · ClinicalTrials.gov registry record · Phase 2
A Trial of FANG™ Vaccine for Participants With Ovarian Cancer
A Phase 2 study, sponsored by Gradalis.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT01309230: Completed Phase 2 study, sponsored by Gradalis.
NCT01309230 is a Phase 2 study that has completed, run by Gradalis. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01309230, a Phase 2 study, has completed, sponsored by Gradalis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
This was a clinical trial for women with ovarian cancer scheduled to have an operation to remove the cancerous tissue. The cancer cells removed during the planned surgery were used to attempt to make the investigational product, named Vigil. Vigil is considered an immunotherapy. In this study, participants who met the requirements to be in the study and if Vigil was successfully made from the participants cancer cells, participants underwent treatment with their standard chemotherapy regimen. At the end of the standard chemotherapy regimen and if there was no evidence of remaining cancer, participants were randomly assigned to receive the Vigil or would be assigned to the standard of care group, which in this study meant no further treatment was given to the participant. The purpose of this study was to compare the difference between the participants who received Vigil versus the usual care after completion of standard chemotherapy and to determine if Vigil delayed or prevented ovarian cancer from coming back.
Primary Outcome
Time to recurrence is the time to progression by Radiological Tumor Assessment by local investigators using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1. Disease recurrence was defined as the appearance of any measurable or evaluable lesion or as asymptomatic CA-125 levels \>35 U/mL at two consecutive measurements, at least one month apart.
Interventions
- BIOLOGICAL Vigil™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2011-03-08 |
| Est. Completion | 2022-02-02 |
| Phase | Phase 2 |
What the finished NCT01309230 record still lists
NCT01309230 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 1 intervention - of which Vigil™ is the first listed.
NCT01309230 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01309230 about?
NCT01309230 is a clinical study titled "A Trial of FANG™ Vaccine for Participants With Ovarian Cancer". This was a clinical trial for women with ovarian cancer scheduled to have an operation to remove the cancerous tissue. The cancer cells removed during the planned surgery were used to attempt to make the investigational product, named Vigil. Vigil is considered an immunotherapy. In this study, parti...
What is the current status of trial NCT01309230?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2011-03-08. Estimated completion is 2022-02-02.
What interventions are being tested in trial NCT01309230?
The interventions under investigation include: Vigil™ (BIOLOGICAL).
Who is sponsoring clinical trial NCT01309230?
This trial is sponsored by Gradalis, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01309230's enrollment target sits among peer trials
39 1459th of 2000 higher than 534 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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