Phase 2a Study to Evaluate Suppression of Methotrexate-induced Mucositis by TK112690

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.

Timeline

Start

2019-05-15

Primary completion

2019-10-10

Completion

2020-03-31

Drugs

Indications