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NCT01671488 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Evaluation of ADXS11-001, Mitomycin, 5-fluorouracil (5-FU) and IMRT for Anal Cancer
A Phase 1 study, sponsored by Brown University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT01671488: Clinical Trial Phase 1 study, sponsored by Brown University.
NCT01671488 is a Phase 1 study that was terminated before completion, run by Brown University. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01671488, a Phase 1 study, was terminated before completion, sponsored by Brown University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
The main purpose of this study is to study the safety and effectiveness of ADXS11-001 when combined with standard chemotherapy and radiation treatment for anal cancer. ADXS11-001 is an investigational agent that is not approved by the FDA to treat anal cancer or any other cancer.
Primary Outcome
Evaluate maximal toxicities via CTCAE version 4.0 All adverse events, serious and non-serious, were captured from date of ICF through 4 weeks post treatment completion- regardless of causality.
Interventions
- DRUG Mitomycin
- RADIATION IMRT
- DRUG 5FU
- BIOLOGICAL Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2013-02 |
| Est. Completion | 2018-02 |
| Phase | Phase 1 |
Why NCT01671488 stopped before completion
NCT01671488 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 4 interventions - of which Mitomycin is the first listed.
NCT01671488 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01671488 about?
NCT01671488 is a clinical study titled "A Phase I/II Evaluation of ADXS11-001, Mitomycin, 5-fluorouracil (5-FU) and IMRT for Anal Cancer". The main purpose of this study is to study the safety and effectiveness of ADXS11-001 when combined with standard chemotherapy and radiation treatment for anal cancer. ADXS11-001 is an investigational agent that is not approved by the FDA to treat anal cancer or any other cancer.
What is the current status of trial NCT01671488?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2013-02. Estimated completion is 2018-02.
What interventions are being tested in trial NCT01671488?
The interventions under investigation include: Mitomycin (DRUG), IMRT (RADIATION), 5FU (DRUG), Treatment (BIOLOGICAL).
Who is sponsoring clinical trial NCT01671488?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01671488's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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