NCT05669521

Phase 2a Study to Evaluate Suppression of 5-Fluorouracil -Induced Mucositis by TK112690

A Phase 2a, Multi-centre, Placebo Controlled, Randomized, Assessor Blind Study of Bolus 5-fluorouracil and Infused Leucovorin Plus Either Infused TK-90 for Parenteral Use or Infused TK-90 Placebo Administered Weekly for 6 Consecutive Weeks to Patients With Colorectal Cancer.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Tosk, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Patients expected to receive a 500 mg/m2 of Leucovorin by iv \& 500 mg/m2 of Fluorouracil (5FU) by iv bolus for their Colorectal Cancer. The patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization at 5 hours \& 11 hours post 5-FU iv bolus. This treatment cycle will continue weekly for 6 weeks. The TK112690 dose will be 45 mg/kg.

Detailed description

Patients expected to receive a 500 mg/m2 of Leucovorin by iv \& 500 mg/m2 of Fluorouracil (5FU) by iv bolus for their Colorectal Cancer. The patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization at 5 hours \& 11 hours post 5-FU iv bolus. This treatment cycle will continue weekly for 6 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 6 weeks. * Study follow-up will be scheduled post two weeks of completion of last dose of Chemotherapy \& TK-90 * 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

Conditions

• Mucositis

Interventions

Type	Name	Description
DRUG	TK-112690	TK112690 treatment Post 5-FU chemotherapy
DRUG	Placebo	Placebo treatment Post 5-FU chemotherapy

Timeline

• Start date: 2022-06-15
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2023-01-03
• Last updated: 2023-08-14

Locations

5 sites across 1 country: India

Regulatory

• FDA-regulated drug study