A CLINICAL TRIAL OF THE INTRA-TUMOURAL CONCENTRATION AND ACTIVITY OF NILOTINIB IN INTRA-CUTANEOUS SCHWANNOMAS - PHNT NilotinibNF2
- Conditions
- In vivo investigation of the intra-tumoural concentration and activity of nilotinib in cutaneous schwannomas (CS) in patienst with Neurofibromatosis 2
- Registration Number
- EUCTR2010-023508-28-GB
- Lead Sponsor
- Plymouth Hospital NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 5
oMale and female patients who fulfil diagnostic criteria for NF2
oMinimum age 18 years
oPresence of at least one CS accessible for biopsy
oKarnofski performance status above 60%.
oAdequate organ function.
oAble to swallow tablets
oAcceptable birth control methods
oNegative 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
oHypersensitivity to nilotinib or any of its excipients
oPregnant or lactating females
oPatients taking concomitant warfarin
oSerious uncontrolled concomitant medical or psychiatric illness.
oImpaired cardiac function
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method