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A Study of Niclosamide in Patients With Resectable Colon Cancer

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ClinicalTrials.gov Identifier: NCT02687009
Recruitment Status : Recruiting
First Posted : February 22, 2016
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Morse, MD, Duke University

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).

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: Niclosamide Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Arm Intervention/treatment
Experimental: Niclosamide Drug: Niclosamide
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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Niclosamide blood levels [ Time Frame: 1 DAY ]
  2. Niclosamide blood levels [ Time Frame: 2 days ]
  3. Niclosamide blood levels [ Time Frame: 8 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of colon adenocarcinoma with a plan to undergo surgical resection no sooner than 7 days from the projected date of study drug initiation. Patients with rectal cancer not receiving pre-operative chemoradiotherapy are also eligible.
  • Karnofsky performance status greater than or equal to 70%
  • Age ≥ 18 years.
  • Adequate hematologic function, with ANC > 1500/microliter, hemoglobin ≥ 9 g/dL (may transfuse or use erythropoietin to achieve this level), platelets ≥ 100,000/microliter; INR <1.5, PTT <1.5X ULN
  • Adequate renal and hepatic function, with serum creatinine < 1.5 mg/dL, bilirubin < 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT and AST ≤ 2.5 x upper limit of normal.
  • Ability to understand and provide signed informed consent that fulfills Institutional Review Board's guidelines.
  • Ability to return to Duke University Medical Center for adequate follow-up, as required by this protocol.

Exclusion Criteria:

  • Patients with concurrent cytotoxic chemotherapy or radiation therapy are excluded
  • Known active brain or leptomeningeal metastases (defined as symptomatic metastases) or continued requirement for glucocorticoids for brain or leptomeningeal metastases. Treated, asymptomatic metastases are permitted provided the patient has been off steroids for at least 1 month prior to day 1 of study drug.
  • Patients with serious intercurrent chronic or acute illness, such as cardiac disease (NYHA class III or IV), hepatic disease, or other illness considered by the Principal Investigator as unwarranted high risk for investigational drug treatment.
  • Patients with a medical or psychological impediment to probable compliance with the protocol should be excluded.
  • Concurrent (or within the last 5 years) second malignancy other than non melanoma skin cancer, cervical carcinoma in situ, controlled superficial bladder cancer, or other carcinoma in situ that has been treated.
  • Presence of a known active acute or chronic infection including: a urinary tract infection, HIV or viral hepatitis.
  • Patients with prior use of niclosamide or allergies to niclosamide will be excluded from the protocol.
  • Concomitant use of strong CYP3A4, CYP 1A2 , or CYP2C9 substrates (See http://medicine.iupui.edu/clinpharm/ddis/main-table).
  • Pregnant and nursing women should be excluded from the protocol since this research may have unknown and harmful effects on an unborn child or on young children. If the patient is sexually active, the patient must agree to use a medically acceptable form of birth control while receiving treatment and for a period of 12 months following the last dose of niclosamide. It is not known whether the treatment used in this study could affect the sperm and could potentially harm a child that may be fathered while on this study.
  • Patients with complete bowel obstruction or who are at high risk for GI perforation or severe hemorrhage. Patients with inflammatory bowel disease.

Information from the National Library of Medicine

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


Contacts
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Contact: Michael A Morse, MD 919-684-5705 michael.morse@dm.duke.edu
Contact: Wanda Honeycutt, RN BSN CCRP 919-668-1861 wanda.honeycutt@dm.duke.edu

Locations
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United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Michael Morse, MD    919-684-5705    michael.morse@duke.edu   
Sponsors and Collaborators
Michael Morse, MD

Publications:
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Responsible Party: Michael Morse, MD, Professor, Duke University
ClinicalTrials.gov Identifier: NCT02687009     History of Changes
Other Study ID Numbers: Pro00066964
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Morse, MD, Duke University:
colon cancer
Wnt pathway
Frizzled
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Niclosamide
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antinematodal Agents