NCT02519582

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Niclosamide	2 g per day orally

Timeline

• Start date: 2015-08-01
• Primary completion: 2019-12-01
• Completion: 2020-08-01
• First posted: 2015-08-11
• Last updated: 2018-09-12

Locations

1 site across 1 country: Germany