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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)

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Niclosamide
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer, S100A4

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité Universitätsmedizin Berlin; Charité Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Niclosamid

Arm Description

Patients receive 2 g niclosamide orally per day until progression or toxicity

Outcomes

Primary Outcome Measures

Progression free survival
defined as the time from patient inclusion to the date of progression

Secondary Outcome Measures

Overall survival
defined as the time from patient inclusion to the date of death or date of last follow-up news (censured data)
Time to progression
Progression according to RECIST
Disease control rate
remission + partial remission + stable disease
Number of Adverse Events > grade 2 toxicities according to NCI Common Toxicity Criteria for Adverse Effects v 4.03
number of adverse events > grade 2 toxicities according to NCI Common Toxicity Criteria for Adverse Effects v 4.03
Number of Serious Adverse Events
number of serious adverse events

Full Information

First Posted
July 30, 2015
Last Updated
September 11, 2018
Sponsor
Charite University, Berlin, Germany
Collaborators
Center for Molecular Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02519582
Brief Title
Drug Trial to Investigate the Safety and Efficacy of Niclosamide Tablets in Patients With Metastases of a Colorectal Cancer Progressing After Therapy
Acronym
Nikolo
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 Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Center for Molecular Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Cancer, S100A4

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Niclosamid
Arm Type
Experimental
Arm Description
Patients receive 2 g niclosamide orally per day until progression or toxicity
Intervention Type
Drug
Intervention Name(s)
Niclosamide
Intervention Description
2 g per day orally
Primary Outcome Measure Information:
Title
Progression free survival
Description
defined as the time from patient inclusion to the date of progression
Time Frame
At 4 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
defined as the time from patient inclusion to the date of death or date of last follow-up news (censured data)
Time Frame
From date of randomization until the date of death, assessed up to 2 years
Title
Time to progression
Description
Progression according to RECIST
Time Frame
From date of randomization until the date of first documented progression, assessed up to 2 years
Title
Disease control rate
Description
remission + partial remission + stable disease
Time Frame
From date of randomization, assessed up to 2 years
Title
Number of Adverse Events > grade 2 toxicities according to NCI Common Toxicity Criteria for Adverse Effects v 4.03
Description
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
Title
Number of Serious Adverse Events
Description
number of serious adverse events
Time Frame
From date of randomization, assessed up to 1 months after end ot therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susen Burock
Phone
0049 (0)30450564648
Email
susen.burock@charite.de
Facility Information:
Facility Name
Charité Universitätsmedizin Berlin; Charité Comprehensive Cancer Center
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susen Burock
Phone
0049(0)30450564648
Email
susen.burock@charite.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
29544454
Citation
Burock S, Daum S, Keilholz U, Neumann K, Walther W, Stein U. Phase II trial to investigate the safety and efficacy of orally applied niclosamide in patients with metachronous or sychronous metastases of a colorectal cancer progressing after therapy: the NIKOLO trial. BMC Cancer. 2018 Mar 15;18(1):297. doi: 10.1186/s12885-018-4197-9.
Results Reference
derived

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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

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