Drug Trial to Investigate the Safety and Efficacy of Niclosamide Tablets in Patients With Metastases of a Colorectal Cancer Progressing After Therapy (Nikolo)

Charité University Medicine Berlin

Status and phase

Unknown

Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: Niclosamide

Study type

Interventional

Funder types

Other

Identifiers

NCT02519582

CCCC-mCRC-01

Details and patient eligibility

About

Phase II trial evaluating the safety and efficacy of oral appliqued niclosamide in patients who are progressive with metachronous or synchronous metastases of colorectal cancer among the previous therapy (Nikolo). Monocentric open-label clinical trial of phase II. All patients received 2 g p.o. niclosamide daily until progression (according to RECIST) or unacceptable toxicity or discontinuation of study for other reasons.

Full description

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

Enrollment

37 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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