A Phase 3, Multi-center, 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 Patients With Head and Neck Cancer Receiving Chemoradiotherapy
Overview
- Phase
- Phase 3
- Intervention
- EN3285
- Conditions
- Oral Mucositis
- Sponsor
- Endo Pharmaceuticals
- Enrollment
- 240
- Locations
- 2
- Primary Endpoint
- NCI v3 to measure severity of OM
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
Brief Summary
Randomized, double-blind, placebo-controlled study for the treatment of head and neck cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral mucositis(OM).
Detailed Description
This randomized, double-blind, placebo-controlled study will be conducted in patients receiving chemoradiotherapy (ChemoRT) for the treatment of head and neck cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral mucositis(OM). The study includes a treatment period of up to 8 weeks, based on the patients' prescribed treatment plan, with a follow-up period of 12 months following completion of radiotherapy (RT).
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years and older
- •newly diagnosed SCC of the oral cavity and/or oropharynx, and are intended for treatment with ChemoRT.
- •Have a clinical plan to receive a minimum of 60 Gy to the oral cavity and/or oropharynx
- •Chemotherapy: cisplatin
- •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
- •Significant
Exclusion Criteria
- •Have OM or other oral conditions at study entry
- •Plan to use Amifostine, Pilocarpine, Cevimeline or Bethanechol
- •Are using a pre-existing feeding tube for nutritional support at study entry
- •Plan to use any drug for the treatment or prevention of OM
- •Have had any prior radiotherapy to the head and neck
- •Have had prior chemotherapy within 6 months preceding enrollment
- •Plan to have concurrent chemotherapy, other than those regimens specified under inclusioncriteria
- •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 the inability to undergo repeat treatments,
Arms & Interventions
EN3285 (NAC ProGelz)
The EN3285 arm is the product under development
Intervention: EN3285
No active ingredients (placebo)
This will be an oral product that contains no active ingredient
Intervention: Placebo
Standard of Care
This arm will reflect the typical standard of care for the patient
Intervention: Standard of care
Outcomes
Primary Outcomes
NCI v3 to measure severity of OM
Time Frame: At 50 Gy
Secondary Outcomes
- WHO criteria for measuring severity of OM(At 50 Gy)