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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2010-023508-28-GB |
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Date of registration:
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30/11/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A CLINICAL TRIAL OF THE INTRA-TUMOURAL CONCENTRATION AND ACTIVITY OF NILOTINIB IN INTRA-CUTANEOUS SCHWANNOMAS - PHNT NilotinibNF2
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Scientific title:
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A CLINICAL TRIAL OF THE INTRA-TUMOURAL CONCENTRATION AND ACTIVITY OF NILOTINIB IN INTRA-CUTANEOUS SCHWANNOMAS - PHNT NilotinibNF2 |
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Date of first enrolment:
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14/04/2011 |
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Target sample size:
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5 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023508-28 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
o Male and female patients who fulfil diagnostic criteria for NF2
o Minimum age 18 years
o Presence of at least one CS accessible for biopsy
o Karnofski performance status above 60%.
o Adequate organ function.
o Able to swallow tablets
o Acceptable birth control methods
o Negative pregnancy test
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion criteria:
o Hypersensitivity to nilotinib or any of its excipients
o Pregnant or lactating females
o Patients taking concomitant warfarin
o Serious uncontrolled concomitant medical or psychiatric illness.
o Impaired cardiac function
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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In vivo investigation of the intra-tumoural concentration and activity of nilotinib in cutaneous schwannomas (CS) in patienst with Neurofibromatosis 2
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Intervention(s)
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Trade Name: Tasigna
Pharmaceutical Form: Capsule
INN or Proposed INN: NILOTINIB
CAS Number: 641571-10-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
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Primary Outcome(s)
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Primary end point(s): OPEN LABEL PHASE 0 STUDY (after discussion with MHRA as licensed drug this is equivalent to phase IV for the purposes of this application)
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Main Objective: • To ensure molecular target inhibition occurs with oral nilotinib in NF2 patients with CS.
• To determine whether target inhibition in serum with oral nilotinib in NF2 patients with ICS can act as a biomarker
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Secondary Objective: • measure steady-state plasma concentrations and intra-tumoural concentrations of nilotinib in CS after 14 days of oral dosing with nilotinib.
• investigate PDFG, Erk phosphorylation, apoptosis, and Ki67 labelling in tumour and blood, before and after treatment with nilotinib to assess molecular activity of nilotinib in CS.
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Secondary ID(s)
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CAMN107GB05T
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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