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ASSG Endorsed Clinical Study

ASSG13 - PVNS

Title PHASE II STUDY OF NILOTINIB IN PIGMENTED VILLO-NODULAR
SYNOVITIS/ TENOSYNOVIAL GIANT CELL TUMOUR (PVNS/TGCT)
Objective 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.
Type International, multicentre, non-randomized, open-label phase II clinical trial with a Bayesian design
Population Men and women 18 years and older with Histologically confirmed diagnosis of inoperable progressive or relapsing PVNS/TGCT OR resectable tumour requesting mutilating surgery
Treatment Nilotinib 400 mg twice a day
Phase Ph II
Drug / Intervention Nilotinib
Sponsor Centre Léon Bérard
Funding Source Novartis
Target accrual 50
Expected Completion 2016
Participating Sites RPAH
Recruitment Status Closed
Numbers Accrued AUS: 7
Publications and Presentations Pending
 
Principal Investigator Professor Jean-Yves BLAY
Contact for Further Information Linda Cowan - Trial Manager
Contact Phone Number 03 9656 3637 linda.cowan@petermac.org
Last update 01-Aug-2017 03:01 PM 

 

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