Efficacy and Safety of Duloxetine in Chinese Solid Tumor Patients with Taxanes-induced Painful Peripheral Neuropathy

Inclusion criteria

• Patients must sign an informed consent form (ICF) voluntarily and be able to understand and comply with the requirements of the study;
• Patients must be 18 to 75 years of age (including cut-offs) on the date of signing the informed consent form, regardless of gender;
• Patients must be diagnosed with malignant solid tumors by pathological histology or cytology in the central laboratory or study center;
• Patients must received treatment with a chemotherapy regimen containing taxanes;
• Patients must have ≥ grade 1 sensory chemotherapy-induced peripheral neuropathy (CIPN) with NRS ≥ 4/10 according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v.5.0 grading scale
• Eastern Cooperative Oncology Group performance status (ECOG PS): 0-2;
• Expected survival of ≥ 3 months;
• Screening values at screening meet the following requirements: (no blood components, cell growth factors, leukocyte-lifting drugs, platelet-lifting drugs, anemia-correcting drugs, etc. are allowed within 14 days prior to obtaining laboratory tests); Complete blood count: neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 90 × 109/L, hemoglobin (Hb) ≥ 90 g/L; Liver function: glutamic aminotransferase (AST), alanine aminotransferase (ALT) and total serum bilirubin (TBIL) ≤ 2 times the upper limit of normal range (ULN) Renal function: serum creatinine (Cr) ≤ ULN or creatinine clearance (CCr) ≥ 80 mL/min (applying the standard Cockcroft -Gault formula);
• Female patients who are non-lactating and must have a negative pregnancy test result;
• Patients of childbearing potential must agree to use effective contraception for at least 30 days after signing the informed consent to the last dose.

Note: Concomitant use of selected analgesics (e.g., opioids, acetaminophen, aspirin, and other NSAIDs) is permitted, but only patients receiving a stable dose during the two weeks prior to enrollment may participate.

Exclusion criteria

• Patients with known hypersensitivity to duloxetine or any of the inactive ingredients in the product;
• Patients on other concomitant medications known to affect 5-hydroxytryptamine (5-HT) levels;
• Patients who must take monoamine oxidase inhibitors for antidepressant treatment；
• Patients with the presence of active brain or meningeal metastases；
• Patients with the presence of uncontrolled closed-angle glaucoma；
• Patients with the presence of neuropathy caused by any type of nerve compression；
• The presence of mental illness, epilepsy, mania, suicidal depression, dementia or alcohol or drug abuse that may have an impact on compliance with trial requirements;
• The presence of comorbid cardiovascular disease, including but not limited to: (1) New York Heart Association (NYHA) criteria ≥ grade 2 heart failure; (2) severe/unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months prior to first dose; (4) atrial fibrillation and supraventricular or ventricular arrhythmias requiring treatment; (5) pre-existing symptomatic superior vena cava syndrome; (6) corrected QT interval (QTc) > 450 ms (men); QTc > 470 ms (women); (7) hypertensive disease not controlled by antihypertensive medication: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg;
• Patients with other medical history or evidence of disease that has the potential to confound trial results are excluded from the study；
• Patients are excluded from the study if investigator/sponsor believes that participation in the study is not in the subject's best interest.