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

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Soligenix

Criteria

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.