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

Phase 2

Completed

• Conditions: Oral Mucositis
• Interventions: Drug: Placebo; Drug: SGX942

• Registration Number: NCT02013050
• Lead Sponsor: Soligenix

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-11
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-17
• Primary Completion: 2015-12
• Study Completion: 2016-09
• Results First Submitted: 2017-02-17
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-03
• Last Update Submitted: 2017-07-28
• Results First Posted: 2017-07-31
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Control
SGX942	SGX942	Investigational Drug i) 1.5 mg/kg ii) 3.0 mg/kg iii) 6.0 mg/kg

Primary Outcome Measures

Name	Time	Method
Duration of Severe Oral Mucositis (SOM)	4 weeks after end of therapy	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.

Secondary Outcome Measures

Name	Time	Method
Residual Severe Oral Mucositis (SOM)	4 weeks after end of therapy	OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. SOM is defined as a WHO score of greater than or equal to 3.
Incidence of Clinically Reported, Non-fungal Infections	4 weeks after end of therapy
Survival	12 months after end of therapy
Duration of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin	4 weeks after end of therapy
Duration of Severe Oral Mucositis (SOM)	4 weeks after end of therapy	OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. SOM is defined as a WHO score of greater than or equal to 3.
Percent of Patients With RECIST 1.1 Classification of "Complete Response"	12 months after end of therapy	The RECIST 1.1 scoring system evaluates both the defined (target) tumor, the non-target lesions, and the appearance of new lesions on radiologic scans as follows: Target Lesion : Complete Response (CR): All target lesions gone Partial Response (PR): \>30% decrease from Baseline Progressive Disease (PD): \>20% increase from smallest sum of longest diameter recorded since treatment started (best response) Stable Disease (SD): Neither PD nor PR; Non-Target Lesion: Complete Response (CR): All non-target lesions gone,Tumor markers gone Stable Disease (SD): Persistence of ≥1 non-target lesion, Tumor marker level elevated Progressive Disease: Enlargement of non-target lesions
Incidence of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin	4 weeks after end of therapy

Trial Locations

Locations (1)

Markey Cancer Center-University of Kentucky; 🇺🇸 Lexington, Kentucky, United States