Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287846
Status:
COMPLETED
Last Update Posted:
2016-08-30
First Post:
2006-02-06
Brief Title:
Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Multicentric Phase III Study Evaluating the Efficacy and Toxicity of Imatinib in Adult Patients With Aggressive Fibromatosis That Cannot be Treated by Surgery or Curative Radiotherapy
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
PURPOSE This phase III trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with recurrent or refractory aggressive fibromatosis
PURPOSE This phase III trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with recurrent or refractory aggressive fibromatosis
Detailed Description:
OBJECTIVES
Primary
Determine the non-progression rate in patients with recurrent or refractory aggressive fibromatosis after 3 months of treatment with imatinib mesylate
Secondary
Determine the non-progression rate in patients after being treated with this drug for 12 months
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
Primary
Determine the non-progression rate in patients with recurrent or refractory aggressive fibromatosis after 3 months of treatment with imatinib mesylate
Secondary
Determine the non-progression rate in patients after being treated with this drug for 12 months
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20515 | None | None | None |
| FRE-FNCLCC-SARCOME-050401 | None | None | None |