EC-18 for Oral Mucositis in Patients With Concomitant Chemoirradiation
Status:
Active, not recruiting
Trial end date:
2022-05-20
Target enrollment:
Participant gender:
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.