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NCT01867086 · ClinicalTrials.gov registry record · Phase 2
Salvage Ovarian FANG™ Vaccine + Carboplatinum
A Phase 2 study, sponsored by Gradalis.
- Completed
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT01867086: Completed Phase 2 study, sponsored by Gradalis.
NCT01867086 is a Phase 2 study that has completed, run by Gradalis. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01867086, a Phase 2 study, has completed, sponsored by Gradalis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with carboplatinum. All patients will have Vigil™ prepared and stored from ovarian tumor cells obtained at the time of primary surgical debulking. Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2/3 hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection, once every 3 weeks.
Primary Outcome
Time to progression (TTP) will be determined following Carboplatinum integrated with Vigil vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production. This will be measured from the treatment start date (date of first dose) to either the date the patient is first recorded as having disease recurrence (even if the patient went off treatment because of toxicity), or the date of death if the patient dies due to any causes before pr
Interventions
- BIOLOGICAL Vigil™ Vaccine
- DRUG Carboplatinum
- DRUG Carboplatinum and Taxol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2013-06 |
| Est. Completion | 2016-04-08 |
| Phase | Phase 2 |
What the finished NCT01867086 record still lists
NCT01867086 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Vigil™ Vaccine is the first listed.
NCT01867086 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01867086 about?
NCT01867086 is a clinical study titled "Salvage Ovarian FANG™ Vaccine + Carboplatinum". This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with carboplatinum. All patients will have Vigil™ prepared and stored from ovarian tumor cells obtained at the time of primary surgical debulking. Patients meeting eligibility criteria will receive either carboplatinum alone...
What is the current status of trial NCT01867086?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2013-06. Estimated completion is 2016-04-08.
What interventions are being tested in trial NCT01867086?
The interventions under investigation include: Vigil™ Vaccine (BIOLOGICAL), Carboplatinum (DRUG), Carboplatinum and Taxol (DRUG).
Who is sponsoring clinical trial NCT01867086?
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 NCT01867086's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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