Clinical Trial: Study of Nilotinib Efficacy in Pigmented Villo-Nodular Synovitis/ Tenosynovial Giant Cell Tumour (PVNS/TGCT)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Study of Nilotinib Efficacy in Pigmented Villo-Nodular Synovitis/ Tenosynovial Giant Cell Tumour (PVNS/TGCT)

Brief 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


Detailed Summary:

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 r
Sponsor: Centre Leon Berard

Current Primary Outcome: 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. [ Time Frame: after 12 weeks (3 months) of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Non progression rate after 24 weeks (6 months) of treatment, based on the response evaluated by CT scan or MRI according to RECIST criteria (RECIST version 1.1). [ Time Frame: after 24 weeks (6 months) of treatment ]
  • Objective tumour response according to RECIST version 1.1 (CR and PR) after 12 weeks of treatment [ Time Frame: after 12 weeks of treatment ]
  • Duration of response [ Time Frame: during the study ]
  • Best overall response [ Time Frame: during the study ]
  • Progression-free survival [ Time Frame: during the study ]
  • Time to progression [ Time Frame: during the study ]
  • Time to treatment failure [ Time Frame: during the study ]
  • Non progression rate after 12 weeks of treatment, based on the response evaluated locally by the investigator in charge using CT scan or MRI and according to RECIST criteria (RECIST version 1.1) [ Time Frame: after 12 weeks of treatment ]
  • Proportion of patients with an operable tumour after nilotinib exposure according to investigator evaluation [ Time Frame: at the end of the study (last visit) ]
  • Concomitant treatment use during the study [ Time Frame: during the study ]
  • Correlation between trough level of nilotinib at 6 weeks and 12 weeks and objective tumour response [ Time Frame: at the end of the study ]
  • Safety evaluation will be based on overall safety profile characterized by type, frequency and severity (as graded using NCI-CTCAE V3.0) of adverse events. [ Time Frame: at the end of the study ]


Original Secondary Outcome: Same as current

Information By: Centre Leon Berard

Dates:
Date Received: December 15, 2010
Date Started: December 2010
Date Completion:
Last Updated: April 15, 2013
Last Verified: April 2013