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EN3285 for the Prevention or Delay of Oral Mucositis in Patients With Head and Neck Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

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

NCT00574860•Endo Pharmaceuticals

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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,

Locations (2)

Commonwealth ENT

Louisville, Kentucky, United States

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

December 1, 2007

Primary Completion Date

June 1, 2009

Completion Date

June 1, 2009

Last Updated

September 20, 2013

Enrollment

240

ACTUAL participants

Conditions

Oral MucositisHead and Neck Cancer

Interventions

EN3285

DRUG

Placebo

DRUG

Standard of care

OTHER

Prevention of Oral Mucositis in Head and Neck Cancer.

NCT05853692

Oral Mucositis

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RECRUITINGPHASE1/PHASE2

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

NCT04585750

Advanced Solid TumorAdvanced Malignant Neoplasm+28 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 20, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Prevention of Oral Mucositis in Head and Neck Cancer.

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

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