A Study of Niclosamide in Patients With Resectable Colon Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02687009|
Recruitment Status : Recruiting
First Posted : February 22, 2016
Last Update Posted : May 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Drug: Niclosamide||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Niclosamide in Patients With Resectable Colon Cancer|
|Actual Study Start Date :||November 7, 2017|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2022|
Niclosamide will be taken orally in the morning of each day from day 1-7 prior to surgery for resection of primary tumor. Niclosamide tablets must be chewed well prior to swallowing.
Other Name: Yomensan
- Dose limiting toxicity [ Time Frame: 5 DAYS ]The NCI Common Toxicity Criteria version 4.0 will be used to grade adverse events to determine dose limiting toxicity for safety measure
- Dose limiting toxicity [ Time Frame: 30 DAYS ]he NCI Common Toxicity Criteria version 4.0 will be used to grade adverse events to determine dose limiting toxicity for safety measure
- Niclosamide blood levels [ Time Frame: 1 DAY ]
- Niclosamide blood levels [ Time Frame: 2 days ]
- Niclosamide blood levels [ Time Frame: 8 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687009
|Contact: Michael A Morse, MDfirstname.lastname@example.org|
|Contact: Wanda Honeycutt, RN BSN CCRPemail@example.com|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Contact: Michael Morse, MD 919-684-5705 firstname.lastname@example.org|