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NCT01438112 · ClinicalTrials.gov registry record · Phase 2
Efficacy Study of Recombinant Adenovirus for Non Muscle Invasive Bladder Cancer
A Phase 2 study, sponsored by CG Oncology.
- Terminated
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT01438112: Clinical Trial Phase 2 study, sponsored by CG Oncology.
NCT01438112 is a Phase 2 study that was terminated before completion, run by CG Oncology. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01438112, a Phase 2 study, was terminated before completion, sponsored by CG Oncology.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
The use of a designed viral vector that can destroy cancer cells while leaving normal cells largely unharmed. The virus also stimulates an immunological response by producing a special factor (GM-CSF) to attract and promote the development of dendritic and T effector cells. It forms the hypothesis that this regimen may be used for people who have failed current forms of treatment and are recommended for cystectomy. It is with hope that this novel therapy will be able to delay or potentially avoid cystectomy for this patient population. Bladder instillation of this agent causes little long lasting side effects and may drastically improve the stimulation of the immune system for local cancer cell death as well as destroying those tumor cells that may have travelled to regional lymph nodes or distant organs.
Primary Outcome
'CR' Proportion is confirmed by negative biopsy, cystoscopy, cytology weekly times 2 with the first assessment three months after first intravesical treatment and then assessed again at 9 month. Two consecutive positive urine cytologies to confirm a persistent or recurrent disease if visual and biopsy is negative. Random biopsy mandatory at the first assessment in the trigone, bladder dome, right, left , anterior and posterior of the bladder wall.
Interventions
- BIOLOGICAL CG0070 Adenovirus Vector
- OTHER Control Arm: Quadruple Choice
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2014-03 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
Why NCT01438112 stopped before completion
NCT01438112 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which CG0070 Adenovirus Vector is the first listed.
NCT01438112 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01438112 about?
NCT01438112 is a clinical study titled "Efficacy Study of Recombinant Adenovirus for Non Muscle Invasive Bladder Cancer". The use of a designed viral vector that can destroy cancer cells while leaving normal cells largely unharmed. The virus also stimulates an immunological response by producing a special factor (GM-CSF) to attract and promote the development of dendritic and T effector cells. It forms the hypothesis t...
What is the current status of trial NCT01438112?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2014-03. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01438112?
The interventions under investigation include: CG0070 Adenovirus Vector (BIOLOGICAL), Control Arm: Quadruple Choice (OTHER).
Who is sponsoring clinical trial NCT01438112?
This trial is sponsored by CG Oncology, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01438112's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 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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