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NCT01116245 · ClinicalTrials.gov registry record · Phase 2

An Assessment of an Attenuated Live Listeria Vaccine in CIN 2+

A Phase 2 study, sponsored by Advaxis.

Terminated
Registry status
Phase 2
Development phase
81
Enrollment target

NCT01116245: Clinical Trial Phase 2 study, sponsored by Advaxis.

NCT01116245 is a Phase 2 study that was terminated before completion, run by Advaxis. The registered enrollment target is 81 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01116245, a Phase 2 study, was terminated before completion, sponsored by Advaxis.

TERMINATED
Registry status
Phase 2
Development phase
81 participants
Enrollment target

Study Summary

Cervical cancer is associated with Human Papilloma Virus. About 57% of cervical cancer is the result of infection by Human Papilloma Virus strain 16 (HPV-16). HPV is a very common virus that can affect the cells of the cervix. E7 is a substance that is made by the HPV virus which causes cervical cancer. The purpose of the study is to test the safety, tolerability (how the drug makes you feel), immunology (effects on the immune system) and efficacy (disease curing effects) of a vaccine called Lovaxin C against E7. The vaccine is designed to cause the immune system to react against the E7 substance in a manner that is intended to reverse the changes to the cervix and prevent cervical cancer from occurring.

Interventions

  • DRUG Placebo Control
  • BIOLOGICAL ADXS11-001 (Lm-LLO-E7)

Trial Details

FieldValue
Enrollment Target 81 participants
Start Date 2010-04
Est. Completion 2016-04
Phase Phase 2

Sponsor

Advaxis

9 total trials

What the Registry Record Tells You About NCT01116245

The ClinicalTrials.gov registry entry for NCT01116245 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advaxis, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo Control is the first listed.

NCT01116245 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01116245 about?

NCT01116245 is a clinical study titled "An Assessment of an Attenuated Live Listeria Vaccine in CIN 2+". Cervical cancer is associated with Human Papilloma Virus. About 57% of cervical cancer is the result of infection by Human Papilloma Virus strain 16 (HPV-16). HPV is a very common virus that can affect the cells of the cervix. E7 is a substance that is made by the HPV virus which causes cervical can...

What is the current status of trial NCT01116245?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2010-04. Estimated completion is 2016-04.

What interventions are being tested in trial NCT01116245?

The interventions under investigation include: Placebo Control (DRUG), ADXS11-001 (Lm-LLO-E7) (BIOLOGICAL).

Who is sponsoring clinical trial NCT01116245?

This trial is sponsored by Advaxis, which has 9 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.