Phase 2a Study to Evaluate Suppression of 5-Fluorouracil -Induced Mucositis by TK112690 (NCT05669521) | Clinical Trial Compass
UnknownPhase 2
Phase 2a Study to Evaluate Suppression of 5-Fluorouracil -Induced Mucositis by TK112690
India24 participantsStarted 2022-06-15
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male and female patients 18 to 75 years old (both inclusive) with a histologically or cytological confirmed diagnosis of colorectal cancer
✓. Patient scheduled to receive bolus 5 FU along with LV as first line or subsequent therapy for treating locally advanced or residual or recurrent or metastatic colorectal cancer.
✓. No prior systemic treatments for cancer (chemotherapy and/or radiotherapy) 4 weeks prior to screening.
✓. Be able to read and understand and provide a signature or thumb impression on the Informed Consent Form (ICF) before entering the study.
✓. No other concurrent, active, invasive malignancy.
✓. ECOG performance status of 0 to 2.
✓. Must have a life expectancy of at least 6 months.
✓. No active angina or uncontrolled arrhythmia.
Exclusion criteria
✕. An active infection including HIV/ HBV/ HCV infection.
✕. Patients who have not fully recovered after prior surgery. (Patients who have had prior surgery and have fully recovered and patients who may have surgery in the future are eligible.)
✕. Unstabilized or symptomatic brain metastasis (History of brain metastases allowed if disease has stabilized or improved after radiation and/or craniotomy).