Phase II Trial to Investigate the Safety and Efficacy of Orally Applied Niclosamide in Patients With Metachronous or Synchronous Metastases of a Colorectal Cancer Progressing After Therapy
Overview
- Phase
- Phase 2
- Intervention
- Niclosamide
- Conditions
- Colorectal Cancer
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Progression free survival
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed 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
Investigators
Susen Burock
MD
Charite University, Berlin, Germany
Eligibility Criteria
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
Exclusion Criteria
- •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
Arms & Interventions
Niclosamid
Patients receive 2 g niclosamide orally per day until progression or toxicity
Intervention: Niclosamide
Outcomes
Primary Outcomes
Progression free survival
Time Frame: At 4 months
defined as the time from patient inclusion to the date of progression
Secondary Outcomes
- Time to progression(From date of randomization until the date of first documented progression, assessed up to 2 years)
- Disease control rate(From date of randomization, assessed up to 2 years)
- Overall survival(From date of randomization until the date of death, assessed up to 2 years)
- Number of Adverse Events > grade 2 toxicities according to NCI Common Toxicity Criteria for Adverse Effects v 4.03(From date of randomization, assessed up to 1 months after end ot therapy)
- Number of Serious Adverse Events(From date of randomization, assessed up to 1 months after end ot therapy)