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Brief Title: A Study of Niclosamide in Patients With Resectable Colon Cancer
Official Title: A Phase I Study of Niclosamide in Patients With Resectable Colon Cancer
Study ID: NCT02687009
Brief Summary: This study evaluates the safety of Niclosamide in patients with colon cancer that are undergoing primary resection of their tumor. This is a phase I study with three dosage levels to determine the maximum tolerated dose (MTD).
Detailed Description: Niclosamide is a drug traditionally used in parasitic infections that has recently been shown to regulated the Wnt signaling pathway in cells at the level of the Frizzled receptor. The Wnt pathway is critical for embryogenesis, differentiation of progenitor cells, and supports proliferation of neoplastic tissue. In cancer, activation of the Wnt pathway leads to increased transcription of genes important for growth, proliferation, differentiation, apoptosis, genetic stability, migration, and angiogenesis. The Wnt pathway has particular importance in colorectal cancer. The purpose of this study is to obtain safety data along with pharmacokinetic data and information on the changes in the WNT pathway signalling following niclosamide administration in humans. This phase I study will support future studies in patients with more advanced cancer and other cancers with dysregulation of the Wnt pathway.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Duke University, Durham, North Carolina, United States