Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RRx-001 · 1 trial · 1 indication
The incidence of SOM defined as the proportion of patients with any WHO Grade \>= 3 (severe to life threatening) oral mucositis during the observation period from the start of CRT through IMRT
| Arm | Type | Description |
|---|---|---|
| RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT) | EXPERIMENTAL | Pretreatment consists of 8 mg RRx-001 given twice weekly during the 2 weeks prior to the start of CRT (4 doses total) followed by the CRT treatment period |
| RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT) | EXPERIMENTAL | Pretreatment consists of 4 mg RRx-001 given twice weekly during the 2 weeks prior to the start of CRT (4 doses total) followed by the CRT treatment period. |
| Placebo Pre-Treatment + Chemoradiation Therapy (CRT) | PLACEBO_COMPARATOR | No doses of RRx-001 will be administered. Patients assigned to this arm will receive placebo twice weekly during the 2 weeks prior to the start of CRT followed by the CRT treatment period. |
| Name | Type | Description |
|---|---|---|
| RRx-001 | DRUG | RRx-001 for injection (4 mg or 8 mg) |
| Intensity Modulated Radiation Therapy (IMRT) | RADIATION | Intensity Modulated Radiation Therapy of up to 72 Gy |
| Cisplatin for injection 100 mg/m2 | DRUG | Cisplatin for injection 100 mg/m2 |
Inclusion Criteria: 1. Pathologically confirmed diagnosis of squamous cell carcinoma (SCC) of the oral cavity or oropharynx Note: Patients with primary cancers that are presumed to be of oropharyngeal origin may be included if they meet radiation field dosing criteria as specified in Inclusion Crit...