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

NCT02013050 | Completed Phase 2 Results

• 1 other identifier: IDR-OM-01
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• Duration of Severe Oral Mucositis (SOM)

  Duration of SOM was defined as the number of days from the onset of SOM until resolution of SOM. If the patient did not meet the requirements for resolution of SOM by the 1-month follow up visit, he/she was considered censored at the 1-month follow-up visit (or point of discontinuation of the study, if the patient had discontinued prior to the end of planned treatment). Patients who did not experience SOM were assigned a duration of 0.01. OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4.

  4 weeks after end of therapy

Secondary Outcomes (8)

• Residual Severe Oral Mucositis (SOM)

  4 weeks after end of therapy

• Duration of Severe Oral Mucositis (SOM)

  4 weeks after end of therapy

• Incidence of Clinically Reported, Non-fungal Infections

  4 weeks after end of therapy

• Percent of Patients With RECIST 1.1 Classification of "Complete Response"

  4 weeks after end of therapy

• Duration of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin

  4 weeks after end of therapy

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Control

Drug: Placebo

SGX942

EXPERIMENTAL

Investigational Drug i) 1.5 mg/kg ii) 3.0 mg/kg iii) 6.0 mg/kg

Drug: SGX942

Interventions

SGX942 DRUG

SGX942

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Soligenix: lead

Study Sites (1)

Markey Cancer Center-University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. Richard Straube
• Organization: Soligenix, Inc.

rstraube@soligenix.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: December 17, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: September 1, 2016
• Last Updated: August 28, 2017
• Results First Posted: July 31, 2017

Record last verified: 2017-07

Locations

US (1)