NCT02519582

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for phase_2 colorectal-cancer

Timeline
Completed

Started Aug 2015

Typical duration for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 11, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

September 12, 2018

Status Verified

September 1, 2018

Enrollment Period

4.3 years

First QC Date

July 30, 2015

Last Update Submit

September 11, 2018

Conditions

Colorectal Cancer

Keywords

Colorectal CancerS100A4

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    defined as the time from patient inclusion to the date of progression

    At 4 months

Secondary Outcomes (5)

  • Overall survival

    From date of randomization until the date of death, assessed up to 2 years

  • Time to progression

    From date of randomization until the date of first documented progression, assessed up to 2 years

  • Disease control rate

    From date of randomization, assessed up to 2 years

  • Number of Adverse Events > grade 2 toxicities according to NCI Common Toxicity Criteria for Adverse Effects v 4.03

    From date of randomization, assessed up to 1 months after end ot therapy

  • Number of Serious Adverse Events

    From date of randomization, assessed up to 1 months after end ot therapy

Study Arms (1)

Niclosamid

EXPERIMENTAL

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

Drug: Niclosamide

Interventions

NiclosamideDRUG

2 g per day orally

Niclosamid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +12 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Universitätsmedizin Berlin; Charité Comprehensive Cancer Center

Berlin, 10117, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29544454DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Niclosamide

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

SalicylanilidesAnilidesAmidesOrganic ChemicalsSalicylamidesAniline CompoundsAmines

Central Study Contacts

Susen Burock

CONTACT

0049 (0)30450564648susen.burock@charite.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 30, 2015

First Posted

August 11, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2019

Study Completion

August 1, 2020

Last Updated

September 12, 2018

Record last verified: 2018-09

Locations

DE(1)