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NCT02773849 · ClinicalTrials.gov registry record · Phase 3
ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
A Phase 3 study, sponsored by Ferring Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 157
- Enrollment target
NCT02773849: Completed Phase 3 study, sponsored by Ferring Pharmaceuticals.
NCT02773849 is a Phase 3 study that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 157 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02773849, a Phase 3 study, has completed, sponsored by Ferring Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 157 participants
- Enrollment target
Study Summary
Previous multi-dose Phase I and Phase II clinical studies have demonstrated that ADSTILADRIN is a safe and effective treatment for BCG-refractory and recurrent NMIBC. This Phase III study is designed to expand those observations using a high dose of ADSTILADRIN in patients that are "BCG Unresponsive" which refers to patients with high-grade NMIBC who are unlikely to benefit from and should not receive further intravesical BCG.
Primary Outcome
A patient in the CIS cohort was judged to have achieved CR where urine cytology was reported as normal, atypical, degenerative, reactive, inflammatory, or nonspecific AND cystoscopy was reported as normal or with findings that did not include evidence of low-grade or high-grade recurrence. Bladder biopsy, if performed (not mandatory), demonstrated an absence of low-grade or high-grade recurrence.
Interventions
- BIOLOGICAL ADSTILADRIN
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2016-09-19 |
| Est. Completion | 2023-05-24 |
| Phase | Phase 3 |
What the finished NCT02773849 record still lists
NCT02773849 is an interventional study that assigns participants to a tested intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which ADSTILADRIN is the first listed.
NCT02773849 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02773849 about?
NCT02773849 is a clinical study titled "ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)". Previous multi-dose Phase I and Phase II clinical studies have demonstrated that ADSTILADRIN is a safe and effective treatment for BCG-refractory and recurrent NMIBC. This Phase III study is designed to expand those observations using a high dose of ADSTILADRIN in patients that are "BCG Unresponsive...
What is the current status of trial NCT02773849?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 157 participants. The study started on 2016-09-19. Estimated completion is 2023-05-24.
What interventions are being tested in trial NCT02773849?
The interventions under investigation include: ADSTILADRIN (BIOLOGICAL).
Who is sponsoring clinical trial NCT02773849?
This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02773849's enrollment target sits among peer trials
157 1505th of 2000 higher than 495 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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