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

Mucositis Clinical Trial

Official title: A Phase 2a, Multi-center, Placebo-Controlled, Randomized, Assessor-blind Study to Assess the Safety & Efficacy of Parenteral TK-90 or Parenteral TK-90 Placebo to Patients Receiving Radiotherapy for Non-Metastatic Squamous Cell Carcinoma of Head and Neck.

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

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.

• 24 patients will be randomized equally into 2 different groups: TK-90 treated or TK-90 placebo treated.

• Screening must be completed within 2 weeks.

• The treatment period for the study is 7 weeks.

• Study follow-up will be scheduled post two weeks of completion of last dose of radiation or early termination through up to 4 weeks.

• Blinding: The study will be partially blinded. The patient and investigator as well as site personnel will be blinded as to whether TK-90 or TK-90 placebo is administered. The CRO, sponsor, and site pharmacist will know whether the patient was administered active drug or TK-90 placebo. ;

Related Conditions & MeSH terms

• Mucositis

• NCT number: NCT05658016
• Study type: Interventional
• Source: Tosk, Inc.
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 17, 2022
• Completion date: September 2023