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Study to Assess Safety and Tolerability of AG013 in Oral Mucositis in Subjects Receiving Induction Chemotherapy for the Treatment of Cancers of the Head and Neck

NCT00938080 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2014-01-07

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and tolerability of AG013 (genetically modified L. lactis bacteria engineered to secrete human Trefoil Factor 1), and to explore the ability of AG013 to attenuate the course and severity of oral mucositis (OM) in subjects receiving induction chemotherapy for the treatment of head and neck cancer.

Conditions

  • Oral Mucositis

Interventions

BIOLOGICAL

AG013

Mouth rinse once a day for 14 days

BIOLOGICAL

AG013

Mouth rinse three times a day for 14 days

BIOLOGICAL

AG013

Mouth rinse six times a day for 14 days

OTHER

Placebo

Mouth rinse once a day for 14 days

OTHER

Placebo

Mouth rinse three times a day for 14 days

OTHER

Placebo

Mouth rinse six times a day for 14 days

Sponsors & Collaborators

  • ActoGeniX N.V.

    lead INDUSTRY

Principal Investigators

  • Barbara A Murphy, MD · Vanderbilt-Ingram Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00938080 on ClinicalTrials.gov