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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Soligenix Identifier:
First received: December 11, 2013
Last updated: May 25, 2016
Last verified: May 2016
To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer.

Condition Intervention Phase
Oral Mucositis
Drug: SGX942
Drug: Placebo
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Soligenix:

Primary Outcome Measures:
  • Oral Mucositis Symptoms [ Time Frame: 4 weeks after end of therapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 78
Study Start Date: December 2013
Estimated Study Completion Date: December 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Drug: Placebo
Experimental: SGX942
Investigational Drug i) 1.5 mg/kg ii) 3.0 mg/kg iii) 6.0 mg/kg
Drug: SGX942


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT02013050

United States, Kentucky
Markey Cancer Center-University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
  More Information

Responsible Party: Soligenix Identifier: NCT02013050     History of Changes
Other Study ID Numbers: IDR-OM-01 
Study First Received: December 11, 2013
Last Updated: May 25, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases processed this record on October 21, 2016