Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis
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ClinicalTrials.gov Identifier: NCT00287846 |
Recruitment Status :
Completed
First Posted : February 7, 2006
Last Update Posted : August 30, 2016
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Tracking Information | |||||
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First Submitted Date ICMJE | February 6, 2006 | ||||
First Posted Date ICMJE | February 7, 2006 | ||||
Last Update Posted Date | August 30, 2016 | ||||
Study Start Date ICMJE | September 2004 | ||||
Actual Primary Completion Date | February 2006 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Non-progression rate [ Time Frame: 3 months ] | ||||
Original Primary Outcome Measures ICMJE | Not Provided | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis | ||||
Official Title ICMJE | 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 | ||||
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 I/II 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. |
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Detailed Description | OBJECTIVES: Primary
Secondary
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Desmoid Tumor | ||||
Intervention ICMJE | Drug: imatinib mesylate | ||||
Study Arms ICMJE | Experimental: Imatinib
400 to 800 mg/day for a maximal 12 months study duration.
Intervention: Drug: imatinib mesylate
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
40 | ||||
Original Enrollment ICMJE | Not Provided | ||||
Actual Study Completion Date ICMJE | June 2010 | ||||
Actual Primary Completion Date | February 2006 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 120 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00287846 | ||||
Other Study ID Numbers ICMJE | CDR0000441039 FRE-FNCLCC-SARCOME-05/0401 EU-20515 |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | UNICANCER | ||||
Study Sponsor ICMJE | UNICANCER | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | UNICANCER | ||||
Verification Date | August 2016 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |