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EC-18 for Mouth Sore
Phase 2
Waitlist Available
Led By Mahesh Kudrimoti, MD
Research Sponsored by Enzychem Lifesciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female age 18 years or older
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 weeks (active) + 4-6 weeks (stfu)
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and effective in treating squamous cell cancers of the mouth, oropharynx, hypopharynx and nasopharynx. The trial is divided into two stages, with the first stage testing different doses of the drug to see what is safe, and the second stage testing the most effective dose to see if it is also effective.
Eligible Conditions
- Mouth Sore
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 weeks (active) + 4-6 weeks (stfu)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 weeks (active) + 4-6 weeks (stfu)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of Severe Oral Mucositis (SOM) during the active treatment and short-term follow-up periods
Secondary outcome measures
Delay in onset of SOM (WHO criteria)
Duration of SOM during the active treatment period
Duration of ulcerative mucositis (WHO criteria)
+5 moreOther outcome measures
Break duration in radiation delivery
Breaks in radiation delivery
Duration of severe oral mucositis as defined by NCI-CTCAE v.4 criteria
+6 moreTrial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: [Part 2] EC-18 2000mgExperimental Treatment2 Interventions
RP2D: EC-18 2000mg (Part 1 result)
Group II: [Part 1] EC-18 500 mgExperimental Treatment2 Interventions
1 capsule of EC-18
Group III: [Part 1] EC-18 2000 mgExperimental Treatment2 Interventions
4 capsules of EC-18 500 mg
Group IV: [Part 1] EC-18 1000 mgExperimental Treatment2 Interventions
2 capsules of EC-18 500 mg
Group V: [Part 1] PlaceboPlacebo Group2 Interventions
Matching placebo
Group VI: [Part 2] PlaceboPlacebo Group2 Interventions
Placebo 2000mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
EC-18
2017
Completed Phase 2
~330
Find a Location
Who is running the clinical trial?
Enzychem Lifesciences CorporationLead Sponsor
6 Previous Clinical Trials
284 Total Patients Enrolled
Mahesh Kudrimoti, MDPrincipal InvestigatorUniversity of Kentucky, Chandler Medical Center, CCTS
1 Previous Clinical Trials
115 Total Patients Enrolled
Dong Moon Shin, MDPrincipal InvestigatorEmory University Winship Cancer Institute
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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