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

Trial ID or NCT#

NCT00938080

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

A Phase 1b, Multi-center, Single Blinded, Placebo-controlled, Sequential Dose Escalation Study to Assess the Safety and Tolerability of Topically Applied AG013 in Subjects Receiving Induction Chemotherapy for the Treatment of Cancers of the Head and Neck

Eligibility Criteria

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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Investigator(s)

A. Dimitrios Colevas
A. Dimitrios Colevas
Medical oncologist, Head and neck specialist, Cutaneous oncology specialist
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)

Contact us to find out if this trial is right for you.

Contact

Cancer Clinical Trials Office
650-498-7061

View on ClinicalTrials.gov