A CLINICAL TRIAL OF THE INTRA-TUMOURAL CONCENTRATION AND ACTIVITY OF NILOTINIB IN INTRA-CUTANEOUS SCHWANNOMAS - PHNT NilotinibNF2

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023508-28-GB

Enrollment

Registered

2010-11-30

Start date

2011-04-14

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In vivo investigation of the intra-tumoural concentration and activity of nilotinib in cutaneous schwannomas (CS) in patienst with Neurofibromatosis 2

Interventions

Trade Name: Tasigna Pharmaceutical Form: Capsule INN or Proposed INN: NILOTINIB CAS Number: 641571-10-0 Concentration unit: mg milligram

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. ; 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 ;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)	—

Measure

Time frame

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. ; 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 ;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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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026