Effectiveness:
• effectiveness is measured by progression-free survival evaluated by RECIST (Response Evaluation Criteria In Solid tumor).
Overall survival For overall survival, the curves are estimated using the Kaplan-Meier method
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patient with metachronous or synchronous metastases of a colorectal cancer progression under standard therapy
no proven brain metastases
no curative option
no standard therapy available
Age \> 18 years
At least one metastases measurable according to Response Evaluation Criteria In Solid Tumors V 1.1 in CT or MRI scan not older than 2 weeks before inclusion into the trial
Lab values within the usual borders for these patient group e.g.
Neutrophil ≥ 1.5x109/ •Platelets ≥ 100x109/L
Leukocytes ≥ 1.0x109/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
Aspartate Aminotransferase ≤ 2.5x Upper Limit of Normal in patients without liver metastases or ≤ 5.0x Upper Limit of Normal in patients with liver metastases
Alanine aminotransferase ≤ 2.5x Upper Limit of Normal in patients without liver metastases \< 5.0 x Upper Limit of Normal in patients with liver metastases
adequate renal function (creatinin ≤ 1.5x Upper Limit of Normal)
Eastern Cooperative Oncology Group 0 - 1
EKG without clinical significant abnormalities
No 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.
No clinical significant heart disease like e.g.
Uncontrolled blood pressure
Heart failure New York Heart Association grade \> 2
Cardiac infarction within the last 12 months
No known uncontrolled concomitant disease despite treatment like e.g.
Chronic obstructive pulmonary disease (COPD)
Serious infections
No known alcohol or drug abuses
Absence of any psychological, familial, sociological or geographical condition, potentially hampering compliance with the study protocol and follow-up schedule
Patients should use adequate birth control measures, during the study treatment period and for at least 3 months after the last study treatment.
For women of childbearing potential (WOCBP):negative pregnancy test 72 hours before the application of the first dose if the study drug
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.
Written informed consent before inclusion according to the International Conference on Harmonisation good clinical practice (ICH GCP) and national/local regulations
You may not be if
Life expectancy \< 3 months
Participation in another interventional study within the last 30 days
Known hypersensitivity against a part of the study drug
Pregnancy or breastfeeding
HIV infection oder active hepatitis B/C
Clareo Health | Drug Trial to Investigate the Safety and Efficacy of Niclosamide Tablets in Patients With Metastases of a Colorectal Cancer Progressing After Therapy
