Study of Nilotinib Efficacy in Pigmented Villo-Nodular Synovitis/ Tenosynovial Giant Cell Tumour (PVNS/TGCT)
Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
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.
The primary objective of the study will be to determine the efficacy of 12 weeks (3 months)
of nilotinib treatment as measured by the non progression rate (Complete response + Partial
Response + Stable disease according to Response Evaluation Criteria In Solid Tumours - RECIST
version 1.1) in patients with progressive or relapsing PVNS/TGCT who cannot be treated by
surgery.
this study is an international, multicentre, non-randomized, open-label phase II clinical
trial with a Bayesian design.
A maximum sample size of 50 patients will be included in the study