EUCTR2016-004161-68-DE进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Pathologically-confirmed squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, or hypopharynx or unknown primary HPV-positive tumor presumed to be of oropharyngeal, nasopharyngeal or
- •hypopharyngeal 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;
- •Negative pregnancy test (serum or urine): negative for females of childbearing potential performed 7 days before IMP administration: a
- •female is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Females of childbearing potential must confirm to use an
- •effective method of birth control during study participation and for 30 days following the last treatment with IMP.
- •Male subjects, when having hetero-sexual intercourse with a female of childbearing potential, must use a condom during study participation and for 90 days following the last treatment with IMP. For non-pregnant female partners of childbearing potential the contraception methods recommended for female participants should also be considered for 90 days after the last treatment with IMP of their male partner.
- •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
排除标准
- •1.Prior radiation to the head and neck
- •2. Increased risk of developing infectious endocarditis: Prosthetic cardiac valves, including transcatheter-implanted prostheses and homografts; Prosthetic material used for cardiac valve repair, such as annuloplasty rings and chords; Previous Infectious Endocarditis; Unrepaired cyanotic congenital heart disease or repaired congenital heart disease, with residual shunts or valvular regurgitation at the site of or adjacent to the site of a prosthetic patch or prosthetic device; Cardiac transplant with valve regurgitation due to a structurally abnormal valve
- •3. Prior gene therapy
- •4.Presence of active infectious oral disease excluding oral candidiasis
- •5.Presence of any oral lesions that may confound the ability to assess oral mucositis grade
- •6.Current use of antibiotic rinses or troches
- •7.Herbal, alternative remedies, and alcohol containing over-the-counter mouthwashes are excluded during the course of the study.
- •8.Current alcohol abuse syndrome
- •9.Chronic immunosuppression
- •10.Known seropositive for HIV
- •11.Use of investigational agent within 30 days of signing informed consent
- •12.Tooth extraction prior to radiation
- •13.Signs and symptoms of active dental disease
- •14.Female subjects who are pregnant or nursing
- •15.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
- •16. Known allergy to excipients of the IMP, such as sodium glutamate, sorbitol, dextrin (from maize starch), anhydrous glucose, phosphate buffer salts and mannitol
研究者
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