Not Yet RecruitingPhase 2ACTRN12612000019808

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)


Sponsor

Centre Leon Berard

Enrollment

50 participants

Start Date

Apr 1, 2012

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study evaluates nilotinib (a targeted cancer drug) for treating pigmented villonodular synovitis (PVNS), also called tenosynovial giant cell tumour, a rare condition causing joint swelling and damage in adults aged 18+. Participants must have progressive disease that cannot be operated on or would require mutilating surgery. Those who are pregnant, have serious heart conditions, liver or kidney disease, or are taking certain medications that interact with nilotinib are excluded.

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

Nilotinib; 2 x 200mg capsule twice daily, orally, for 12 months


Locations(5)

United Kingdom

Netherlands

Italy

Poland

France

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ACTRN12612000019808