Oral Mucositis Clinical Trial
Official title:
A Phase 2,Double-Blind, Randomized, Placebo-Controlled, Dose Escalating, Multicenter Study of SGX942 For the Attenuation of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck
Verified date | May 2016 |
Source | Soligenix |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer.
Status | Active, not recruiting |
Enrollment | 78 |
Est. completion date | December 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and is planned to receive a standard course of concomitant CRT. - Patients who have received surgery are eligible if surgery is performed within 6 weeks prior to study initiation. - Planned to receive standard cisplatin chemotherapy administered either weekly or every third week. - Must be able to read and understand informed consent - Adequate birth control methods for the duration of the study Exclusion Criteria: - Current mucositis. - Prior radiation to the head and neck. - Chemotherapy treatment within the previous 12 months. - Tumors of the lips, sinuses, salivary glands or nasopharynx. - Unknown primary tumor. - Stage 4c metastases. - Evidence of significant hepatic, hematologic, or immunologic disease. - Women who are pregnant or breast-feeding. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Markey Cancer Center-University of Kentucky | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Soligenix |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oral Mucositis Symptoms | 4 weeks after end of therapy | Yes |
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