Phase 2a Study to Evaluate Suppression of Methotrexate-induced Mucositis by TK112690
Status:
Completed
Trial end date:
2020-03-31
Target enrollment:
Participant gender:
Summary
Patients will receive methotrexate at a dose of 45 mg/m2 administered weekly for 4
consecutive weeks as an iv infusion along with a nutritional supplement administered two
hours before the methotrexate. One hour before the methotrexate treatment the patients will
be administered the first infusion of the day of either TK112690 or placebo depending on
randomization. Five hours after the methotrexate treatment the patients will be administered
the second treatment of either TK112690 or placebo depending on randomization. The TK112690
dose will be 45 mg/kg.