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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02013050
• Other study ID #: IDR-OM-01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 11, 2013
• Last updated: May 25, 2016
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2016
• Source: Soligenix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Drug:
• SGX942

• Placebo

Locations

Country	Name	City	State
United States	Markey Cancer Center-University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Soligenix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral Mucositis Symptoms		4 weeks after end of therapy	Yes