Phase 2a Study to Evaluate Suppression of Radiotherapy-induced Mucositis by TK112690
Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
Patients expected to receive a continuous course of radiation as single daily fractions of
2.0 Gy treatment with a cumulative radiation dose of 70 Gy. The radiation can be 2DRT,
3DRT,IMRT etc. Prior to each radiation treatment the patients will receive a one-hour
infusion of TK-90 or equivalent TK-90 placebo depending on randomization. 6 Hours after the
completion of TK-90 infusion or TK-90 placebo dose, the patients will receive another
identical TK-90 or TK-90 placebo treatment depending on randomization. This treatment cycle
will continue for 7 weeks. The TK112690 dose will be 45 mg/kg.