Overview

This trial is active, not recruiting.

Condition oral mucositis
Treatments sgx942, placebo
Phase phase 2
Sponsor Soligenix
Start date December 2013
End date December 2015
Trial size 78 participants
Trial identifier NCT02013050, IDR-OM-01

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Control
placebo
(Experimental)
Investigational Drug i) 1.5 mg/kg ii) 3.0 mg/kg iii) 6.0 mg/kg
sgx942

Primary Outcomes

Measure
Oral Mucositis Symptoms
time frame: 4 weeks after end of therapy

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Soligenix.
Location data was received from the National Cancer Institute and was last updated in May 2016.