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EC-18 for Oral Mucositis in Patients With Concomitant Chemoirradiation

NCT03200340 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2023-07-27

No results posted yet for this study

Summary

This is a Phase 2, randomized, double-blind, placebo-controlled, 2-stage trial in subjects with squamous cell cancers of the mouth, oropharynx, hypopharynx and nasopharynx planned to receive standard fractionated IMRT-delivered radiotherapy with concomitant chemotherapy (cisplatin). Informed consent will be obtained from each subject prior to enrollment.

The trial will be performed in 2 stages:

Stage 1 will consist of a blinded parallel group safety study of 4 cohorts in which 24 subjects will be randomized (1:1:1:1) into four equally sized groups to receive one of three doses of EC-18 (500 mg, 1000 mg, 2000 mg; unit dose of 500 mg) or placebo. Stage 2 of the study will evaluate both safety and efficacy.

Stage 2 will consist of eighty (80) subjects who will be randomized in a 1:1 scheme to receive either placebo or 2000 mg of EC-18 as determined by iDSMB in Stage 1.

Conditions

Interventions

DRUG

EC-18

Oral administration of EC-18 twice daily

DRUG

Placebo

Placebo to match EC-18 capsule administration

Sponsors & Collaborators

  • Enzychem Lifesciences Corporation

    lead INDUSTRY

Principal Investigators

  • Dong Moon Shin, MD · Emory University Winship Cancer Institute

  • Mahesh Kudrimoti, MD · University of Kentucky, Chandler Medical Center, CCTS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-03
Primary Completion
2021-05-14
Completion
2021-05-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03200340 on ClinicalTrials.gov