Evaluation of the efficacy of nilotinib in the treatment of patients with pigmented villo-nodular synovitis / tenosynovial giant cell tumour
Phase II study of nilotinib efficacy in pigmented villo-nodular synovitis / tenosynovial giant cell tumour (PVNS/TGCT)
Centre Leon Berard
50 participants
Apr 1, 2012
Interventional
Conditions
Summary
The purpose of this study is to explore the efficacy of nilotinib as a treatment of patients with progressive or relapsing pigmented villo-nodular synovitis / tenosynovial giant cell tumour (PVNS /TGCT) who cannot be treated by surgery. This study is an international, multicentre, non-randomised, open-label phase II clinical trial with a Bayesian design. Who is it for? You may be eligible for this study if you are aged 18 years and over, have a histologically confirmed diagnosis of inoperable progressive or relapsing PVNS/TGCT OR resectable tumour requesting mutilating surgery, and give your consent to take part. The full inclusion criteria details can be found in the relevant section of this form. Trial details: In this study, you will receive the drug nilotinib in the form of 2 x 200mg capsules twice daily, taken orally over a total period of 12 months. You will also be required to regularly attend clinic for routine tests and assessments.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Nilotinib; 2 x 200mg capsule twice daily, orally, for 12 months
Locations(5)
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ACTRN12612000019808