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2 Study Matches
EC-18 for Oral Mucositis in Patients With Concomitant Chemoirradiation
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.
18 Years and over
• 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.
• 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
Drug: EC-18, Drug: Placebo
Intra-oral Treatment of OLP With Rivelin®-CLO Patches
Participants with symptomatic Oral Lichen Planus lesions will be treated with Rivelin® patches containing either 0, 1, 5, or 20 μg clobetasol per patch. Each participant will apply up to 6 patches twice daily for 4 weeks.
18 Years and over
• OLP patients with at least one visible and measurable symptomatic ulcerative OLP lesion, assessable via OLP Clinician Reported Outcome Measure (OLPClinROM).
• Patients aged ≥ 18 years.
• Patients practicing daily oral hygiene (by tooth brushing and/or mouth rinse) and willing to maintain at least their routine oral hygiene procedure during study participation.
• Willingness to keep already used permitted concomitant medication, food supplements (e.g. probiotics) or herbals, which might have in the discretion of the investigator a potential influence on OLP, on a stable basis during the study.
• Patients requiring more than 6 patches (corresponding to an area of approximately 3 cm2 per patch) to cover symptomatic ulcerative and erythematous OLP lesions at baseline visit.
• Ongoing active visible fungal, bacterial or viral infection of oral mucosa, including ongoing treatment of those at baseline.
• Patient with any un-healed oral surgery (including recent diagnostic biopsies, if applicable) or oral laser therapeutic wound(s) at baseline visit.
• Any of the following systemic treatments prior to baseline visit: Corticosteroids, Antibiotics, Retinoids, Immunosuppressive drugs (e.g. azathioprine, cyclosporine, mycophenolate mofetil, or biologics), Antimycotics.
• Any of the following topical treatments used in the oral cavity prior to baseline visit: Corticosteroids, Antibiotics, Cyclosporine, Tacrolimus, Pimecrolimus, Antimycotics, Retinoids.
• Phototherapy in oral cavity prior to baseline visit: UVB, PUVA.
• Current participation in another clinical study and/or having received treatment with any non-marketed / investigational medicinal product (drug substance or medical device) within 4 weeks prior to screening.
• Known or suspected intolerance/hypersensitivity/resistance to clobetasol propionate or any component of the investigational medicinal product.
• Patients who previously have failed to respond to OLP treatments with systemic glucocorticosteroids, methotrexate, cyclosporine, retinoids and/or azathioprine.
• Any history of squamous cell carcinoma (even if resected), as well as history of other non-squamous cell carcinoma (e.g. sarcoma, salivary gland tumors) that have been managed with radiation or chemotherapy.
• History of cancer (except resected cutaneous basal cell carcinoma and except in situ cervical cancer) unless it can be documented that the patient has been in a disease-free state for at least 5 years. In case of clinical suspicion of malignancy in the oral cavity, a patient can only be included after an excluding biopsy.
• Professional dental cleaning within 2 weeks prior to baseline and unwillingness to refrain from professional dental cleaning during study conduct.
• Close affiliation with the investigator (e.g. a close relative) or persons working at the study sites or patient who is an employee of the Sponsor's company.
• Pregnant, confirmed by a positive pregnancy test, or nursing (lactating) women, or women of childbearing potential (WOCP) planning to become pregnant or WOCP not using or willing to continue to use a defined highly effective method of contraception throughout the study.
Drug: Clobetasol Propionate
Oral Lichen Planus
Patch, Rivelin-Clo Patch, Oral Lichen Planus, Ulcerative, Erythematous, OLP, OLPClinROM, OLPSSM