EC-18 for Oral Mucositis in Patients With Concomitant Chemoirradiation

• Status: Active, not recruiting
• Trial end date: 2022-05-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Enzychem Lifesciences Corporation

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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