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

Inclusion Criteria

• •1. Male and female patients 18 to 75 years old (both inclusive) with a histologically or cytological confirmed diagnosis of colorectal cancer
• •2. 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.
• •3. No prior systemic treatments for cancer (chemotherapy and/or radiotherapy) 4 weeks prior to screening.
• •4. Be able to read and understand and provide a signature or thumb impression on the Informed Consent Form (ICF) before entering the study.
• •5. No other concurrent, active, invasive malignancy.
• •6. ECOG performance status of 0 to 2.
• •7. Must have a life expectancy of at least 6 months.
• •8. No active angina or uncontrolled arrhythmia.
• •9. Not pregnant or nursing. Women of childbearing potential must have a negative serum pregnancy test at screening and on the day before dosing and must use medically acceptable methods of birth control. Acceptable methods of birth control include oral or transdermal contraceptives, condoms, spermicidal foam, IUD, progestin implant or injection, abstinence, vaginal ring, or sterilization of partner. The reason for non-childbearing potential, such as bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or post-menopausal for more than or equal to 1 year, must be specified in the patient's medical history file and CRF.
• •10. Mucositis Grade less than or equal to 1 per WHO Scale and Xerostomia of Grade less than or equal to 2 per CTCAE
• •11. Adequate bone marrow function as per CTCAE V5, defined as follows:
• •i) Absolute neutrophil count more than or equal to 1500 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to randomization ii) Platelets more than or equal to 100,000 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to randomization iii) Hemoglobin more than or equal to 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to randomization (Note: The use of transfusion or other intervention to achieve Hgb more than 8.0 g/dl is acceptable).
• •12. Adequate hepatic function with bilirubin less than or equal to 1.5 x upper-normal limit (ULN), AST or ALT less than or equal to 3x ULN within 2 weeks prior to randomization
• •13. Adequate renal function with serum creatinine less than 1.5 mg/dl and creatinine clearance (CrC) more than or equal to 50 ml/min within 2 weeks prior to randomization determined by 24-hour collection or estimated by Cockcroft-Gault formula. CrC male is equal to \[(140 - age) x (wt in kg)\] / \[(Serum Cr mg/dl) x (72)\]. CrC female is equal to 0.85 x (CrCl male)
• •14. Normal serum calcium or normal corrected serum calcium within 2 weeks prior to randomization; formula for corrected calcium if albumin valued is below normal range: Corrected calcium (mg/dl) is equal to (4 - \[patients albumin (g/dl)\] x 0.8) + patient measured calcium (mg/dl).