Severe Oral Mucositis MedDRA version: 9.1 Level: LLT Classification code 10028130 Term: Mucositis oral
Conditions
Interventions
Product Name: NAC ProGelz® (NAC Oromucosal Liquid)
Product Code: EN3285
Pharmaceutical Form: Oromucosal liquid*
CAS Number: 616-91-1
Current Sponsor code: EN3285
Other descriptive name: N-Acetylcyste
Sponsors
Endo Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the relative efficacy of EN3285 compared with placebo in the delay to onset of severe (NCI grade >2) OM. The coprimary objective of this study is to evaluate the relative efficacy of EN3285 compared with placebo in prevention of severe (NCI grade >2) OM at a cumulative dose of 50 Gy.;Secondary Objective: The secondary objectives of the study are to compare EN3285 with placebo with respect to: • Safety through the collection of AEs and laboratory data • Delaying the onset of severe OM (WHO grade >2) • Prevention of severe OM (WHO grade >2) • Percent of time (days) spent on opiates for oral pain during the course of RT • Reducing the need for interventional placement of feeding tubes for nutritional support due to OM ;Primary end point(s): The primary endpoint will be radiation dose to onset of severe OM (NCI grade >2) over the cumulative dose range 0 to 50 Gy. The coprimary endpoint will be the proportion of subjects with severe OM (NCI grade >2) at a cumulative dose of 50 Gy. The study will enroll subjects who are scheduled to receive a minimum cumulative RT dose of 60 Gy during a treatment period of up to 8 weeks. Due to the high variability of the treatment regimens not only across centers, but between subjects, this study will look at group comparisons up to and at a cumulative RT dose of 50 Gy. | — |
Countries
United Kingdom
Outcome results
None listed