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NCT02399813 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study of Axalimogene Filolisbac (ADXS11-001) in Participants With Carcinoma of the Anorectal Canal
A Phase 2 study, sponsored by Advaxis.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT02399813: Completed Phase 2 study, sponsored by Advaxis.
NCT02399813 is a Phase 2 study that has completed, run by Advaxis. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02399813, a Phase 2 study, has completed, sponsored by Advaxis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
This is a single arm Phase 2 study. Stage 1 and 2 of the study are monotherapy evaluations of ADXS11-001 in 31 and 24 participants, respectively with persistent/recurrent, loco-regional or metastatic squamous cell carcinoma (SCCA) of the anorectal canal that have received at least 1 regimen for the treatment of advanced disease.
Primary Outcome
Best response was defined as achievement of complete response (CR) or partial response (PR) per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Interventions
- DRUG Axalimogene filolisbac
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2016-06-02 |
| Est. Completion | 2019-01-03 |
| Phase | Phase 2 |
What the finished NCT02399813 record still lists
NCT02399813 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Axalimogene filolisbac is the first listed.
NCT02399813 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02399813 about?
NCT02399813 is a clinical study titled "A Phase 2 Study of Axalimogene Filolisbac (ADXS11-001) in Participants With Carcinoma of the Anorectal Canal". This is a single arm Phase 2 study. Stage 1 and 2 of the study are monotherapy evaluations of ADXS11-001 in 31 and 24 participants, respectively with persistent/recurrent, loco-regional or metastatic squamous cell carcinoma (SCCA) of the anorectal canal that have received at least 1 regimen for the ...
What is the current status of trial NCT02399813?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2016-06-02. Estimated completion is 2019-01-03.
What interventions are being tested in trial NCT02399813?
The interventions under investigation include: Axalimogene filolisbac (DRUG).
Who is sponsoring clinical trial NCT02399813?
This trial is sponsored by Advaxis, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02399813's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 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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