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Table 1 Nikolo trial inclusion and exclusion criteria

From: Phase II trial to investigate the safety and efficacy of orally applied niclosamide in patients with metachronous or sychronous metastases of a colorectal cancer progressing after therapy: the NIKOLO trial

Inclusion criteria
 Disease related
  Patients with metachronous or synchronous metastases of a colorectal cancer progressing under standard therapy
  No proven brain metastases
  No curative option available
  No standard therapy available
  At least one metastasis has to be measurable according to RECIST V 1.1 in X-ray computed tomography or magnetic resonance imaging (not older than 2 weeks before inclusion into the trial)
 Demographic
  Age > 18 years
  Eastern Cooperative Oncology Group performance status ECOG 0–1
 Laboratory
  Absolute neutrophil count ≥ 1.5 × 109/ L
  Platelet count ≥ 100 × 109/L
  Leukocytes ≥ 1.0 × 109/L
  Hemoglobin ≥ 9.0 g/dL or 5.59 mmol/l
  Bilirubin ≤ 2 x Upper Limit of Normal (ULN) if not due to Gilbert’s syndrome
  AST ≤ 2.5xULN in patients without liver metastases or ≤ 5.0xULN in patients with liver metastases
  ALT ≤ 2.5xULN in patients without liver metastases or < 5.0xULN in patients with liver metastases
  Adequate renal function (creatinine ≤ 1.5xULN)
 Ethical/Other
  Electrocardiography without clinical significant abnormalities
  Written informed consent before inclusion according to the ICH-GCP and national/local regulations
  Patients should use adequate birth control measures, during the study treatment period and for at least 3 months after the last study treatment
  Women of childbearing potential need to have a negative pregnancy test 72 h before the application of the first dose of niclosamide
  Patients who are breastfeeding must stop breastfeeding before the first dose of the study drug and not restart till 8 week after the last drug intake
Exclusion criteria
 Concurrent conditions
  Pregnant or lactating females
  Other malignant disease (except colorectal cancer) within the last 5 years before inclusion in the trial except adequately treated basal cell carcinoma of the skin or squamous cell carcinoma of the skin, in situ carcinoma of the cervix. Patients with a malignant disease in history have to be free of disease for 5 years
  Clinical significant heart disease like e.g. uncontrolled blood pressure; heart failure NYHA grade > 2; cardiac infarction within the last 12 months
  Known uncontrolled concomitant disease despite treatment like e.g. chronic obstructive pulmonary disease
  Known alcohol or drug abuse
  Serious infection
  Any psychological, familial, sociological or geographical condition, potentially hampering compliance with the study protocol and follow-up schedule
 Ethical/Other
  Participation in another interventional study within the last 30 days
  Known hypersensitivity against a part of the study drug
  Life expectancy < 3 months
  Human immunodeficiency virus infection or active hepatitis B/C
  Patients that are committed to an institution by official or judicial order
  Persons that are depending on the sponsor, investigator or deputy