Colorectal CancerPhase 2NikoloNCT02519582
Drug Trial to Investigate the Safety and Efficacy of Niclosamide Tablets in Patients With Metastases of a Colorectal Cancer Progressing After Therapy
A Phase 2 study testing Niclosamide in people with Colorectal Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Niclosamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2015to Aug 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 30Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité Universitätsmedizin Berlin; Charité Comprehensive Cancer Center
Berlin, 10117
Susen Burock, 0049(0)30450564648, susen.burock@charite.de
About this study
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
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.
Read the 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
- Conditions
- Colorectal Cancer
- Being tested
- Niclosamide
- Keywords
- Colorectal Cancer, S100A4
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiclosamideDrug
2 g per day orally
| Study group | Role | What they receive |
|---|---|---|
| Niclosamid | Experimental | Patients receive 2 g niclosamide orally per day until progression or toxicity Receives: Drug: Niclosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
defined as the time from patient inclusion to the date of progression
Measured: At 4 months
Secondary outcomes (5)
Overall survival
defined as the time from patient inclusion to the date of death or date of last follow-up news (censured data)
Measured: From date of randomization until the date of death, assessed up to 2 years
Time to progression
Progression according to RECIST
Measured: From date of randomization until the date of first documented progression, assessed up to 2 years
Disease control rate
remission + partial remission + stable disease
Measured: 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
number of adverse events > grade 2 toxicities according to NCI Common Toxicity Criteria for Adverse Effects v 4.03
Measured: From date of randomization, assessed up to 1 months after end ot therapy
Number of Serious Adverse Events
number of serious adverse events
Measured: From date of randomization, assessed up to 1 months after end ot therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2019 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Molecular Medicine
- Responsible party
- Principal investigator, Susen Burock, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519582
- Sponsor's protocol ID
- CCCC-mCRC-01
- Acronym
- Nikolo
- Status last verified
- Sep 2018
- First submitted
- 30 Jul 2015
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29544454
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02519582
- Acronym / sponsor ID
- Nikolo / CCCC-mCRC-01
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, S100A4
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Center for Molecular Medicine
- Study start
- Aug 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 11 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Niclosamid | Experimental | Drug: NiclosamidePatients receive 2 g niclosamide orally per day until progression or toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niclosamide2 g per day orally | Drug | Niclosamid |
Primary outcome
Progression free survival
Time frame: At 4 months
defined as the time from patient inclusion to the date of progression
5 secondary outcomes
Overall survival
Time frame: From date of randomization until the date of death, assessed up to 2 years
Time to progression
Time frame: From date of randomization until the date of first documented progression, assessed up to 2 years
Disease control rate
Time frame: 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
Time frame: From date of randomization, assessed up to 1 months after end ot therapy
Number of Serious Adverse Events
Time frame: From date of randomization, assessed up to 1 months after end ot therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Derived from this study: PubMed 29544454Burock 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Niclosamide in people with Colorectal Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susen Burock (0049 (0)30450564648, susen.burock@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: At 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02519582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.