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 - Limaye, Sewanti Atul; Haddad, Robert I.; Cilli, Fiona; Sonis, Stephen T.; Colevas, A. Dimitrios; Brennan, Michael T.; Hu, Kenneth S.; Murphy, Barbara A. (Cancer, 2013)
Keywords: 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