A Phase 2, multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of topically-applied AG013 for the attenuation of oral mucositis in subjects with cancers of the head and neck receiving concomitant chemoradiation therapy

Oragenics, Inc.0 个研究点目标入组 200 人开始时间: 2018年5月4日最近更新: 2020年7月20日

适应症

试验速览

暂无简介。

•-Pathologically-confirmed squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx or unknown primary HPV-positive tumor presumed to be of oropharyngeal origin.
•-Tumor HPV status established
•-Planned to receive either primary or post-operative CRT
•-Planned IMRT (Intensity-Modulated Radiotherapy)
•-Planned administration of cisplatin administered weekly or tri-weekly during RT
•-Males or females 21 years or older
•-Karnofsky performance score (KPS) = 70%
•-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;
•Calculated Creatinine Clearance of 50 ml/min;
•Pregnancy test (serum or urine): negative for females of childbearing potential: a female 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)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 160
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•1.Prior radiation to the head and neck
•2.Presence of active infectious oral disease excluding oral candidiasis
•3.Presence of any oral lesions that may confound the ability to assess oral mucositis grade
•4.Current use of antibiotic rinses or troches
•5.Herbal, alternative remedies, and alcohol containing over-the-counter mouthwashes are excluded during the course of the study.
•6.Current alcohol abuse syndrome
•7.Chronic immunosuppression
•8.Known seropositive for HIV
•9.Use of investigational agent within 30 days of signing informed consent
•10.Tooth extraction prior to radiation
•11.Signs and symptoms of active dental disease
•12.Female subjects who are pregnant or nursing
•13.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

发起方