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

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ClinicalTrials.gov Identifier: NCT02519582
Recruitment Status : Recruiting
First Posted : August 11, 2015
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
Center for Molecular Medicine
Information provided by (Responsible Party):
Susen Burock, Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Niclosamide Phase 2

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Niclosamid
Patients receive 2 g niclosamide orally per day until progression or toxicity
Drug: Niclosamide
2 g per day orally




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: At 4 months ]
    defined as the time from patient inclusion to the date of progression


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From date of randomization until the date of death, assessed up to 2 years ]
    defined as the time from patient inclusion to the date of death or date of last follow-up news (censured data)

  2. Time to progression [ Time Frame: From date of randomization until the date of first documented progression, assessed up to 2 years ]
    Progression according to RECIST

  3. Disease control rate [ Time Frame: From date of randomization, assessed up to 2 years ]
    remission + partial remission + stable disease

  4. Number of Adverse Events > grade 2 toxicities according to NCI Common Toxicity Criteria for Adverse Effects v 4.03 [ Time Frame: From date of randomization, assessed up to 1 months after end ot therapy ]
    number of adverse events > grade 2 toxicities according to NCI Common Toxicity Criteria for Adverse Effects v 4.03

  5. Number of Serious Adverse Events [ Time Frame: From date of randomization, assessed up to 1 months after end ot therapy ]
    number of serious adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Bilirubin ≤ 2 x Upper Limit of Normal (ULN) if not due to Gilbert's syndrome
  • Aspartate Aminotransferase ≤ 2.5x Upper Limit of Normal in patients without liver metastases or ≤ 5.0x Upper Limit of Normal in patients with liver metastases
  • Alanine aminotransferase ≤ 2.5x Upper Limit of Normal in patients without liver metastases < 5.0 x Upper Limit of Normal in patients with liver metastases
  • adequate renal function (creatinin ≤ 1.5x Upper Limit of Normal)
  • Eastern Cooperative Oncology Group 0 - 1
  • EKG without clinical significant abnormalities
  • No other malignant disease (except colorectal cancer) within the last 5 years before inclusion in the trial except adequately treated basal cell carcinoma of the skin or squamous cell carcinoma of the skin, in situ carcinoma of the cervix. Patients with a malignant disease in history have to be free of disease for 5 years.
  • No clinical significant heart disease like e.g.
  • Uncontrolled blood pressure
  • Heart failure New York Heart Association grade > 2
  • Cardiac infarction within the last 12 months
  • No known uncontrolled concomitant disease despite treatment like e.g.
  • Chronic obstructive pulmonary disease (COPD)
  • Serious infections
  • No known alcohol or drug abuses
  • Absence of any psychological, familial, sociological or geographical condition, potentially hampering compliance with the study protocol and follow-up schedule
  • Patients should use adequate birth control measures, during the study treatment period and for at least 3 months after the last study treatment.
  • For women of childbearing potential (WOCBP):negative pregnancy test 72 hours before the application of the first dose if the study drug
  • Patients who are breastfeeding must stop breastfeeding before the first dose of the study drug and not restart till 8 week after the last drug intake.
  • Written informed consent before inclusion according to the International Conference on Harmonisation good clinical practice (ICH GCP) and national/local regulations

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

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): NCT02519582


Contacts
Contact: Susen Burock 0049 (0)30450564648 susen.burock@charite.de

Locations
Germany
Charité Universitätsmedizin Berlin; Charité Comprehensive Cancer Center Recruiting
Berlin, Germany, 10117
Contact: Susen Burock    0049(0)30450564648    susen.burock@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Center for Molecular Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Susen Burock, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02519582     History of Changes
Other Study ID Numbers: CCCC-mCRC-01
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018

Keywords provided by Susen Burock, Charite University, Berlin, Germany:
Colorectal Cancer
S100A4

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Niclosamide
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antinematodal Agents