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NCT03495921 · ClinicalTrials.gov registry record · Phase 3
A Trial For Participants With Ewing's Sarcoma Treated With Vigil in Combination With Irinotecan and Temozolomide
A Phase 3 study, sponsored by Gradalis.
- Terminated
- Registry status
- Phase 3
- Development phase
- 32
- Enrollment target
NCT03495921: Clinical Trial Phase 3 study, sponsored by Gradalis.
NCT03495921 is a Phase 3 study that was terminated before completion, run by Gradalis. The registered enrollment target is 32 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03495921, a Phase 3 study, was terminated before completion, sponsored by Gradalis.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 32 participants
- Enrollment target
Study Summary
The goal of this clinical trial was to compare participants with first relapse or refractory Ewing's sarcoma when treated with investigational product (Vigil) in addition to the standard treatment of irinotecan and temozolomide compared to the standard treatment of irinotecan and temozolomide alone. The main question it aimed to answer is "Will participants who receive Vigil in addition to irinotecan and temozolomide have a prolonged time to progression and improved quality of life compared to the participants who receive irinotecan and temozolomide alone?".
Primary Outcome
Progression Free Survival (PFS) is defined as the time from randomization to the event of disease recurrence/progression according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1) for target lesions and assessed CT/MRI by local investigator.
Interventions
- DRUG Temozolomide
- DRUG Irinotecan
- BIOLOGICAL Vigil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2018-08-21 |
| Est. Completion | 2022-01-20 |
| Phase | Phase 3 |
Why NCT03495921 stopped before completion
NCT03495921 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 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Temozolomide is the first listed.
NCT03495921 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03495921 about?
NCT03495921 is a clinical study titled "A Trial For Participants With Ewing's Sarcoma Treated With Vigil in Combination With Irinotecan and Temozolomide". The goal of this clinical trial was to compare participants with first relapse or refractory Ewing's sarcoma when treated with investigational product (Vigil) in addition to the standard treatment of irinotecan and temozolomide compared to the standard treatment of irinotecan and temozolomide alone....
What is the current status of trial NCT03495921?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 32 participants. The study started on 2018-08-21. Estimated completion is 2022-01-20.
What interventions are being tested in trial NCT03495921?
The interventions under investigation include: Temozolomide (DRUG), Irinotecan (DRUG), Vigil (BIOLOGICAL).
Who is sponsoring clinical trial NCT03495921?
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 NCT03495921's enrollment target sits among peer trials
32 1909th of 2000 higher than 87 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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