EC-18 for Oral Mucositis in Patients With Concomitant Chemoirradiation

Completed · Phase 2 · Has a placebo group

Conditions studied: Stomatitis

In brief

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.

Key facts

Study ID

NCT03200340

Run by

Enzychem Lifesciences Corporation

People needed

105

Starts

2018-07-03

Expected to finish

2021-05-14

Last updated by the study team

2023-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent
• Male or female age 18 years or older
• Pathologically confirmed diagnosis of squamous cell carcinoma of the mouth, oropharynx, hypopharynx or nasopharynx
• Planned to receive IMRT with daily fractions of 2.0 Gy to 2.2 Gy to a cumulative dose of at least 60 Gy and a maximum of 72 Gy
• Radiation fields to include at least two mucositis sites at risk (buccal mucosa, floor of mouth, ventral and lateral tongue, soft palate) in which both sites receive a minimum cumulative dose of 55 Gy
• Planned to receive concomitant single agent chemotherapy with cisplatin given either weekly or tri-weekly
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
• Screening Laboratory Values Hemoglobin ≥ 9g/dL White blood cell count ≥ 3,500 cells/mm3 Absolute neutrophil count ≥ 1,500 cells/mm3 Total bilirubin ≤ 2 times upper limit of normal Serum AST and ALT ≤ 2.5 times upper limit of normal Serum creatinine concentration ≤ 2mg/mL Pregnancy test: negative for females of childbearing potential
• Subjects of childbearing potential must consent to utilize a medically accepted means of contraception throughout the active dosing period with study medication and for a minimum of 30 days following the administration of the last dose of study medication.

You may not qualify if…

• Unable to provide informed consent or, in the opinion of the Principal Investigator, comply with the protocol.
• Prior radiation therapy to the head and neck
• Metastatic disease
• Presence of active infectious disease excluding oral candidiasis
• Presence of oral mucositis or any oral lesion that would confound the assessment of oral mucositis
• Active systemic disease or condition known to impact the risk or course of oral mucositis including chronic immunosuppression and known seropositivity for HIV
• Use of any investigational agent within 30 days of the first radiation dose
• Active alcohol abuse syndrome
• Subjects with a history of hepatitis of any etiology or hepatic insufficiency
• Pregnant or nursing at the time of signing informed consent
• Known sensitivity to any study medication
• Unwilling or unable to complete study diary
• Any other condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the protocol

Where it is running

• Veterans Affairs Long Beach Health Care System — Long Beach, California, United States
• UCLA Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
• Miami Cancer Institute — Miami, Florida, United States
• Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• University of Kentucky, Chandler Medical Center, CCTS — Lexington, Kentucky, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Mount Sinai - Union Square — New York, New York, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Oregon Health and Science University — Portland, Oregon, United States
• VA Portland HealthCare System — Portland, Oregon, United States
• St. Luke's Cancer Center - Anderson Campus — Easton, Pennsylvania, United States
• Hope Cancer Center of East Texas — Tyler, Texas, United States
• Baylor Scott & White Medical Center - Hillcrest — Waco, Texas, United States
• MultiCare Institute for Research and Innovation — Spokane, Washington, United States
• MultiCare Institute for Research and Innovation — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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