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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
2 g per day orally
Charité Universitätsmedizin Berlin; Charité Comprehensive Cancer Center
Berlin, Germany
RECRUITINGProgression free survival
defined as the time from patient inclusion to the date of progression
Time frame: At 4 months
Overall survival
defined as the time from patient inclusion to the date of death or date of last follow-up news (censured data)
Time frame: From date of randomization until the date of death, assessed up to 2 years
Time to progression
Progression according to RECIST
Time frame: From date of randomization until the date of first documented progression, assessed up to 2 years
Disease control rate
remission + partial remission + stable disease
Time frame: From date of randomization, assessed up to 2 years
Number of Adverse Events > grade 2 toxicities according to NCI Common Toxicity Criteria for Adverse Effects v 4.03
number of adverse events \> grade 2 toxicities according to NCI Common Toxicity Criteria for Adverse Effects v 4.03
Time frame: From date of randomization, assessed up to 1 months after end ot therapy
Number of Serious Adverse Events
number of serious adverse events
Time frame: From date of randomization, assessed up to 1 months after end ot therapy
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