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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Soligenix
Sponsor:
Information provided by (Responsible Party):
Soligenix
ClinicalTrials.gov Identifier:
NCT02013050
First received: December 11, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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: March 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Control
Drug: Placebo
Experimental: SGX942
Investigational Drug i) 1.5 mg/kg ii) 3.0 mg/kg iii) 6.0 mg/kg
Drug: SGX942

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013050

Contacts
Contact: Adam Rumage 609-538-8200

Locations
United States, Kentucky
Markey Cancer Center-University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Principal Investigator: Mahesh Kudrimoti, MD         
Sponsors and Collaborators
Soligenix
  More Information

No publications provided

Responsible Party: Soligenix
ClinicalTrials.gov Identifier: NCT02013050     History of Changes
Other Study ID Numbers: IDR-OM-01
Study First Received: December 11, 2013
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mucositis
Stomatitis
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 20, 2014