Multicentric Phase I/II Study Evaluating the Efficacy and Toxicity of Imatinib in Adult Patients With Aggressive Fibromatosis That Cannot be Treated by Surgery or Curative Radiotherapy
- Determine the non-progression rate in patients with recurrent or refractory aggressive
fibromatosis after 3 months of treatment with imatinib mesylate.
- Determine the non-progression rate in patients after being treated with this drug for
- Determine the toxic effects of this drug in these patients.
- Determine the tolerance to this drug in these patients.
- Determine the response rate in patients treated with this drug
- Determine progression free and overall survival of patients treated with this drug.
- Determine the quality of life of patients treated with this drug.
- Correlate clinical, biological, and genomic markers with response and long-term stable
disease in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate once daily for up to 12 months in the absence of
disease progression or unacceptable toxicity.
Quality of life is assessed periodically.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Non-progression rate at 3 months
Jean-Yves Blay, MD, PhD
Hopital Edouard Herriot - Lyon