A Study to Investigate the Safety and Efficacy of TRK-750 for the Treatment of Patients With CIPN (Chopin Study)

Exclusion Criteria

• •1. Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, ability to complete the study, and study assessments.
• •2. Presence of skin conditions in the affected dermatome that, in the judgement of the Investigator, could interfere with evaluation of the neuropathic pain condition.
• •3. Presence of non-CIPN pain that may interfere with study assessments and/or self-evaluation of peripheral neuropathic pain.
• •4. Known history of significant hypersensitivity, intolerance, or allergy.
• •5. Peripheral neuropathy caused by tumour infiltration or compression of spinal nerves or surgical trauma.
• •6. Active clinically significant infection
• •7. Unstable cardiac disease or myocardial infarction within 6 months prior to study entry.
• •8. Patients with uncontrolled major psychiatric disorders, such as major depression or psychosis.
• •9. History of pre-existing symptomatic neuropathy prior to chemotherapy, including neuropathy due to alcoholism, vitamin B deficiency, diabetes, hypothyroidism, human immunodeficiency virus (HIV), congenital neuropathy, and toxic neuropathy.
• •10. Female patients who are pregnant (including a positive urine pregnancy test at Screening or on Day 1) or lactating.
• •11. Inadequate haematological function, defined as neutrophil count \< 1.0 × 10\^9/L and platelet count \< 50 × 10\^9/L with measured values of these in the clinical laboratory tests conducted at Screening. At Screening, haematology assessments may be repeated once.
• •12. Inadequate renal function, defined as estimated glomerular filtration rate (eGFR) ≤ 59 mL/min, i.e., Creatinine Clearance (CrCl) as calculated using the Cockcroft-Gault equation with measured values of these in the clinical laboratory tests conducted at Screening:
• •1. \[1.23 × (140 - age) × (weight in kg)\] ÷ (serum creatinine in μmol/L) - if male.
• •2. \[1.04 × (140 - age) × (weight in kg)\] ÷ (serum creatinine in μmol/L) - if female.
• •At Screening, clinical laboratory assessments may be repeated once.
• •13. History of alcoholism or drug/chemical abuse within 1 year prior to Day 1.
• •14. Positive test results for drugs of abuse at Screening (confirmed by repeat) or Day 1, unless consistent with use of prescription medication and approved by the Sponsor (or delegate). A repeated positive test result for cocaine, phencyclidine, methadone, or amphetamines, for nonmedical use, are unconditionally exclusionary.
• •15. Positive test for hepatitis B surface antigen (HbsAg), hepatitis C antibody (HCV), or HIV antibody at Screening.
• •16. Use of any medication in the absence of appropriate washout periods that, in the opinion of the Investigator, may influence the result of the study, or the patient's ability to participate in the study.
• •17. Has received an investigational product or has been treated with an investigational device within 90 days prior to first drug administration and will not start any other investigational product or device study within 90 days after last study drug administration.
• •18. Likely to require chemotherapy during the study period or any other treatment that may interfere with compliance with the protocol, ability to complete the study, and study assessments.
• •19. Plans to change current medications or any other intervention intended to treat or relieve CIPN signs or symptoms from Screening to end of study.
• •20. Has previously received TRK-750.