EN3285 for the Prevention or Delay of Oral Mucositis in Patients With Head and Neck Cancer

Endo Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Oral Mucositis; Head and Neck Cancer

Treatments: Other: Standard of care; Drug: EN3285; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00574860

EN3285-301

Details and patient eligibility

About

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).

Full 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).

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Significant 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,

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 3 patient groups, including a placebo group

EN3285 (NAC ProGelz)

Experimental group

Description:

The EN3285 arm is the product under development

Treatment:

Drug: EN3285

No active ingredients (placebo)

Placebo Comparator group

Description:

This will be an oral product that contains no active ingredient

Treatment:

Drug: Placebo

Standard of Care

Other group

Description:

This arm will reflect the typical standard of care for the patient

Treatment:

Other: Standard of care