Oral Mucositis, Squamous Cell Carcinoma of the Oral Cavity and Oropharynx
Conditions
Keywords
OM, Head and Neck Cancer, SGX942, Dusquetide, Squamous Cell Carcinoma
Brief summary
To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer
Interventions
DRUGSGX942
1.5 mg/mL SGX942 administered as a 4 minute IV infusion, twice per week starting within 3 days after initiating radiation therapy and continuing through 2 weeks after radiation therapy ends.
DRUGPlacebo
Placebo is 0.9% sodium chloride (normal saline). The treatment preparation, frequency and duration of therapy are identical to that of the active drug.
Sponsors
Soligenix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Biopsy-proven squamous cell carcinoma of the oral cavity or oropharynx without distant organ metastases * Scheduled to receive cisplatin chemotherapy of 80-100 mg/m² * Scheduled to receive a continuous course of fractionated, conventional external beam with a cumulative radiation dose between 55 and 72 Gy at each site
Exclusion criteria
* Current mucositis * Current, clinically significant, active infection that in the opinion of the Investigator would make them an unfit participant in the trial * Planned to receive Erbitux™ (Cetuximab) or similar targeted therapy between Baseline and 6 weeks post-RT * Prior radiation to the head and neck * Chemotherapy treatment within the previous 12 months * Tumors of the lips, sinuses, salivary glands, nasopharynx, hypopharynx, or larynx * Evidence of significant renal, hepatic, hematologic, or immunologic disease determined by any one of the following: Estimated creatinine clearance \<30 mL/min; ALT or AST level greater than 10-fold the upper limit of normal or total bilirubin greater than 3-fold the upper limit of normal; Manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy; Thrombocytopenia; or CD4+ T cell count below 200 cells per μL * Evidence of immediate life-threatening disease or a life expectancy of less than 3 months * Women who are pregnant or breast-feeding * Participation in any study involving administration of an investigational agent within 30 days of randomization into this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Severe Oral Mucositis (SOM) | approx. 13 weeks | To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis (SOM; defined as World Health Organization \[WHO\] Grade ≥3). Duration of SOM is defined as the number of days from the onset of SOM until resolution of SOM. OM is evaluated using the published WHO OM grading scale that uses a scale of 0 to 4, with SOM defined as a score ≥3. |
Countries
Belgium, France, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SGX942 Patients are randomized 1:1 active/placebo.
SGX942: 1.5 mg/mL SGX942 administered as a 4 minute IV infusion, twice per week starting within 3 days after initiating radiation therapy and continuing through 2 weeks after radiation therapy ends. | 127 |
| Placebo Patients are randomized 1:1 active/placebo.
Placebo: Placebo is 0.9% sodium chloride (normal saline). The treatment preparation, frequency and duration of therapy are identical to that of the active drug. | 139 |
| Total | 266 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 5 |
| Overall Study | Noncompliance with Study Procedures | 1 | 1 |
| Overall Study | Physician Decision | 2 | 4 |
| Overall Study | Reason other than described | 0 | 2 |
| Overall Study | Termination by Sponsor | 0 | 1 |
| Overall Study | Withdrawal by Subject | 9 | 12 |
Baseline characteristics
| Characteristic | Total | Placebo | SGX942 |
|---|---|---|---|
| Age, Continuous | 58.1 years STANDARD_DEVIATION 8.19 | 58.8 years STANDARD_DEVIATION 8.74 | 57.2 years STANDARD_DEVIATION 7.48 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 15 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 218 Participants | 113 Participants | 105 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 24 Participants | 11 Participants | 13 Participants |
| HPV Status Negative | 81 Participants | 47 Participants | 34 Participants |
| HPV Status Positive | 185 Participants | 92 Participants | 93 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 246 Participants | 128 Participants | 118 Participants |
| Sex: Female, Male Female | 50 Participants | 28 Participants | 22 Participants |
| Sex: Female, Male Male | 216 Participants | 111 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 127 | 9 / 139 |
| other Total, other adverse events | 123 / 127 | 135 / 139 |
| serious Total, serious adverse events | 74 / 127 | 64 / 139 |
Outcome results
Primary
Duration of Severe Oral Mucositis (SOM)
To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis (SOM; defined as World Health Organization \[WHO\] Grade ≥3). Duration of SOM is defined as the number of days from the onset of SOM until resolution of SOM. OM is evaluated using the published WHO OM grading scale that uses a scale of 0 to 4, with SOM defined as a score ≥3.
Time frame: approx. 13 weeks
Population: The analysis population was defined as all participants receiving a minimum of 55 Gray of cumulative radiation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SGX942 | Duration of Severe Oral Mucositis (SOM) | 12.5 days |
| Placebo | Duration of Severe Oral Mucositis (SOM) | 20.0 days |
p-value: 0.1798Log Rank