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

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

Official Title
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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

Conditions
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Oral Mucositis

Intervention / Treatment
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* Drug: SGX942
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Control | Drug: Placebo<br> <br> |
| Experimental: SGX942<br>Investigational Drug i) 1.5 mg/kg ii) 3.0 mg/kg iii) 6.0 mg/kg | Drug: SGX942<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual Severe Oral Mucositis (SOM) | 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. | 4 weeks after end of therapy | 
| Duration of Severe Oral Mucositis (SOM) | 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. | 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 | 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 | 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 | 
| Incidence of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin |  | 4 weeks after end of therapy | 
| Survival |  | 12 months after end of therapy | 
| Percent of Patients With RECIST 1.1 Classification of Complete Response | 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 | 12 months after end of therapy |