Phase II Study of Nilotinib Efficacy in Pigmented Villo-Nodular Synovitis/ Tenosynovial Giant Cell Tumour (PVNS/TGCT)
A key secondary objective of the study will be to determine the efficacy of 24 weeks (6
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 key secondary objective was defined for the purpose of a further analysis (not
described in this protocol) which will pool the data of the PVNS study with those of a
similar concomitant study conducted in the US and Australia.
The other secondary objectives will be:
To evaluate the efficacy of nilotinib according to:
- The objective tumour response rate (Complete response + Partial Response according to
RECIST version 1.1) after 12 weeks of treatment
- The duration of treatment response
- The best overall response obtained during the study
- The progression-free survival (PFS)
- The time to progression (TTP)
- The time to treatment failure (TTF)
- The proportion of patients with an operable tumour after nilotinib exposure according
to investigator evaluation
- The description of concomitant treatments use
- The correlation between trough levels of nilotinib and objective tumour response To
assess the safety of nilotinib for PVNS/TGCT patients
An exploratory objective of the study will be to study the relationship between the
objective tumour response and the following tumour characteristics (tissues collected in a
prior surgery, or by biopsy, upon specific acceptance by the patient; if no tissue is
available in the prior surgery, a biopsy will be done at visit 2):
Presence of COL6A3/CSF1 fusion gene Presence of M-CSF, CSF1R, KIT, PDGFRA and B on
immunohistochemistry Presence of phosphorylated c-fms on tumour samples Activation of the
PI3K/Akt/mTor pathway, presence of activating mutations of ras, and other potential
molecular alterations
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
the non progression rate after 12 weeks (3 months) of treatment, based on the response evaluated by CT scan or MRI according to RECIST criteria (RECIST version 1.1) and validated by a central review committee.
after 12 weeks (3 months) of treatment
No
Jean Yves Blay, PR
Principal Investigator
Centre Léon Bérard, Lyon
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
PVNS
NCT01261429
December 2010
April 2013
Name | Location |
---|