Phase 1b, multicenter, single blinded, placebo‐controlled, sequential dose escalation study to assess the safety and tolerability of topically applied AG013 in subjects with locally advanced head and neck cancer receiving induction chemotherapy

BACKGROUND Oral mucositis (OM) is a significant toxicity of induction chemotherapy for locally advanced head and neck cancer (LAHNC). The safety and tolerability of AG013, an oral rinse containing recombinant Lactococcus lactis secreting mucosal protectant human trefoil factor 1 (hTFF1), was evaluat...

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Vydané v:	Cancer Ročník 119; číslo 24; s. 4268 - 4276
Hlavní autori:	Limaye, Sewanti Atul, Haddad, Robert I., Cilli, Fiona, Sonis, Stephen T., Colevas, A. Dimitrios, Brennan, Michael T., Hu, Kenneth S., Murphy, Barbara A.
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	Hoboken, NJ Wiley-Blackwell 15.12.2013
Predmet:	Administration, Topical Adolescent Adult Aged Antineoplastic Agents - administration & dosage Antineoplastic Agents - adverse effects Biological and medical sciences Female head and neck cancer Head and Neck Neoplasms - drug therapy Head and Neck Neoplasms - metabolism Head and Neck Neoplasms - microbiology Humans Induction Chemotherapy Lactococcus lactis - genetics Lactococcus lactis - metabolism Male Medical sciences Middle Aged Mouth Mucosa - drug effects Mouth Mucosa - microbiology mouth rinse Mouthwashes - administration & dosage Mouthwashes - adverse effects Multiple tumors. Solid tumors. Tumors in childhood (general aspects) oral mucositis Otorhinolaryngology (head neck, general aspects and miscellaneous) Otorhinolaryngology. Stomatology safety and tolerability Stomatitis - chemically induced Stomatitis - drug therapy Stomatitis - microbiology Stomatitis - prevention & control Trefoil Factor-1 Tumor Suppressor Proteins - administration & dosage Tumor Suppressor Proteins - biosynthesis Tumor Suppressor Proteins - pharmacokinetics Tumors Young Adult Human oral mucositis Stomatology Toxicity Multicenter study Single dose Malignant tumor Induction treatment safety and tolerability Increasing dose Stomatitis mouth rinse Cancerology Sequential Placebo ENT disease Head and neck cancer Oral cavity disease Locally advanced stage induction chemotherapy Cancer head and neck cancer
ISSN:	0008-543X, 1097-0142, 1097-0142
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