Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03237325 | DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer | PHASE3 | COMPLETED | 266 | — | — | Dec 4, 2017 | Jun 24, 2021 | Nov 8, 2022 | 53 | United States, Belgium +3 |
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.
| Arm | Type | Description |
|---|---|---|
| SGX942 | EXPERIMENTAL | Patients are randomized 1:1 active/placebo. |
| Placebo | PLACEBO_COMPARATOR | Patients are randomized 1:1 active/placebo. |
| Name | Type | Description |
|---|---|---|
| SGX942 | DRUG | 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. |
| Placebo | DRUG | Placebo is 0.9% sodium chloride (normal saline). The treatment preparation, frequency and duration of therapy are identical to that of the active drug. |
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 radiat...