A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Oral Mucositis

In brief

To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer.

Key facts

Study ID

NCT02013050

Run by

Soligenix

People needed

111

Starts

2013-12-01

Expected to finish

2016-09-01

Last updated by the study team

2017-08-28

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Markey Cancer Center-University of Kentucky — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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