NCT04046250

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

Phase 2a, Multi-center, Placebo-controlled, Randomized, Partially Blinded, Study Infused TK112690 or or Placebo Administered Along With Methotrexate Weekly for Four Consecutive Weeks to Patients With Recurrent or Residual SCCHN

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Tosk, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 infusion. 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. * A total of 22 patients will be enrolled into one of 2 different dose groups: TK-112690 treated or placebo treated. * Screening must be within 15 days of subject enrollment. * Patients will remain for observation at the clinical site for a minimum of 25 hours post initial TK112690 or placebo dose. * Study follow-up will occur on Week 6, two weeks after the last dosing of methotrexate. * Blinding: The study will be partially blinded. The patient and investigator will be blinded as to whether TK112690 or placebo is administered. The CRO, sponsor, and site pharmacist will know whether the patient was administered active drug or placebo.

Conditions

• Mucositis

Interventions

Type	Name	Description
DRUG	TK-112690	TK112690 treatment pre-methotrexate treatment
DRUG	Placebo TK-112690	Placebo

Timeline

• Start date: 2019-05-15
• Primary completion: 2019-10-10
• Completion: 2020-03-31
• First posted: 2019-08-06
• Last updated: 2023-08-25
• Results posted: 2021-06-03

Locations

3 sites across 1 country: India

Regulatory

• FDA-regulated drug study