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#



not recruiting iconNOT RECRUITING


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

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Willing and able to understand and sign the study specific Informed Consent Form (ICF) approved by the site's Institutional Review Board - Males or females 18 years or older - Recently diagnosed with pathologically-confirmed squamous cell carcinoma of the head and neck (e.g., oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, lips, sinuses, salivary glands, unknown primary) - Planned to receive at least two cycles of induction chemotherapy of the same regimen consisting of cisplatin/fluorouracil (PF) or cisplatin/fluorouracil/docetaxel (PFT). The planned CT cycles must be of the same length and must be a minimum of 14 days in length - Karnofsky performance score ≥ 60% - Screening laboratory assessments: - Hemoglobin ≥ 10g/dl - White blood count ≥ 3500 cells/mm3 - Absolute neutrophil counts ≥ 1500 cells/ mm3 - Direct bilirubin ≤ 2x upper limit of normal (ULN) - Serum AST and ALT ≤ 3 x ULN - Serum creatinine ≤ 2 mg/dl - Serum pregnancy test: negative for females of childbearing potential: A women is considered to be of child bearing potential unless she has had a tubal ligation or is postmenopausal (without a menstrual period for at least one year) - Subjects of childbearing potential must agree to utilize effective contraceptive methods of birth control during study participation and for 30 days following the last treatment with IMP - Have documented mouth pain during CT Cycle 1 (i.e., OMDQ question 2 score of ≥ 2 during CT Cycle 1)
Exclusion Criteria:
  1. - Prior radiation to the head and neck - Chemotherapy within 21 days prior to study start - Presence of active infectious disease excluding oral candidiasis - Current use of antibiotic rinses or troches - Alcohol abuse syndrome; recovered alcoholics may be included - Presence of OM (WHO Grade > 0) - Chronic immunosuppression - Known seropositive for HIV or hepatitis B or C - Use of investigational agent within 30 days of signing informed consent - Teeth extractions within 7 days prior to the start of CT administration - Female subjects who are pregnant or nursing - Known sensitivity to any investigational agent - Inability to give informed consent or comply with study requirements - Unwilling or unable to complete subject diary - Any other clinical condition, psychiatric condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable or to comply with follow-up visits


A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD
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)
Quynh-Thu Le, MD
Quynh-Thu Le, MD
Radiation oncologist
Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)

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Cancer Clinical Trials Office