EUCTR2007-006549-42-GB进行中（未招募）1 期
A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of EN3285 for the Prevention or Delay to Onset of Severe Oral Mucositis in Subjects with Head and Neck Cancer Receiving Chemoradiotherapy - N/A
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
- •Subjects will be included in the study if they:
- •Are 18 years and older with newly diagnosed clinically and histologically confirmed SCC of the oral cavity and/or oropharynx, and are intended for treatment with ChemoRT. (Subjects with unknown primary tumors are allowed depending on target RT as defined below as well as postoperative subjects.)
- •Have a clinical plan to receive a minimum of 60 Gy to the oral cavity and/or oropharynx using any of the following:
- •–Standard fractionation to deliver 1.8 to 2.2 Gy per day in a single fraction
- •–Intensity Modulated Radiotherapy (IMRT) and Helio IMRT are allowed
- •Will receive chemotherapy consisting of one of the following regimens:
- •–Cisplatin 80 - 100 mg/m2 in 21-day cycles
- •–Weekly cisplatin 30 mg/m2
- •Have a WBC =3500 per cubic millimeter
- •Have a platelet count =100,000 per cubic millimeter
- •Have adequate renal function as determined by the principal investigator prior to enrollment
- •Are willing and able to undergo oral assessments
- •Have a Karnofsky Performance Status score =70
- •Have the ability to understand the protocol and provide informed consent
- •If female and of childbearing potential, must have negative serum pregnancy test
- •If female, must be practicing abstinence or using a medically acceptable form of contraception (eg, intrauterine device, hormonal birth control, or double barrier method). For this study, all females are considered to be of childbearing potential unless they are post-menopausal (at least 1 year since last menses), biologically sterile, or surgically sterile (ie, hysterectomy, bilateral oophorectomy or tubal ligation).
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will be excluded from participation in the study if they:
- •Have OM or other oral conditions that would preclude a complete and accurate assessment of OM during treatment at study entry
- •Are using a pre-existing feeding tube for nutritional support at study entry
- •Plan to use Amifostine, Pilocarpine, Cevimeline and Bethanechol
- •Plan to use any drug for the treatment or prevention of OM (including topical steroids and topical anti-inflammatory agents such as Benadryl) except for analgesics and other treatments identified as acceptable in the protocol (see Section 5.5)
- •Have had any prior radiotherapy to the head and neck
- •Have intent to treat with daily hyperfractionated RT regimens, brachytherapy or interstitial implantation, or any form of boost where the daily dose exceeds 2.2 Gy.
- •Have had prior chemotherapy within 6 months preceding enrollment
- •Plan to have concurrent chemotherapy, other than those regimens specified under inclusion criteria
- •Have received other investigational drugs in the 30 days preceding initiation of study drug or during administration of study drug
- •Have medical conditions that require the use of chronic steroid therapy
- •Have a recent, serious, nonmalignant medical condition that, in the opinion of the principal investigator, makes the subject unsuitable for study participation (eg, subjects who are immunocompromised)
- •In the opinion of the principal investigator, have a medical, sociological, or psychological impediment to probable compliance with protocol
- •Have the inability to undergo repeat treatments, clinical evaluations and other diagnostic procedures required by the protocol
研究者
相似试验
招募中
1 期
Study to Evaluate the Safety and Efficacy of SRP-9001 in Subjects With Duchenne Muscular DystrophyMedDRA version: 20.0Level: PTClassification code 10013801Term: Duchenne muscular dystrophySystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.1Level: PTClassification code 10052655Term: Duchenne muscular dystrophy gene carrierSystem Organ Class: 10010331 - Congenital, familial and genetic disordersDuchenne Muscular DystrophyEUCTR2020-002372-13-ITSAREPTA THERAPEUTICS, INC.116
暂停
3 期
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Non-Ambulatory and Ambulatory Participants With Duchenne Muscular Dystrophy (DMD) (ENVISION)Duchenne Muscular Dystrophy2024-512626-28-00Sarepta Therapeutics Inc.95
招募中
1 期
Study to evaluate the Safety and Efficacy of SRP-9001 in non ambulatory and ambulatory Subjects with Duchenne Muscular DystrophyDuchenne Muscular DystrophyEUCTR2020-002372-13-SESarepta Therapeutics, Inc.148
尚未招募
3 期
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of SRP-9001 (Delandistrogene Moxeparvovec) in Non-Ambulatory and Ambulatory Participants With Duchenne Muscular Dystrophy (DMD)Duchenne Muscular DystrophyJPRN-jRCT2033230274Patrick O Malley4
已完成
3 期
A Multinational, Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer10038597Prostate cancerNL-OMON50210Medivation Inc., a wholly owned subsidiary of Pfizer Inc.42