Clinical Trial: Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: An Open-label Multicenter Phase II Study of Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors
Brief Summary: This study assesses the safety and efficacy of imatinib mesylate treatment of patients with malignant peripheral nerve sheath tumors
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Response rate assessed by a Tumor MRI scan every 6 weeks or if clinically indicated. [ Time Frame: Every 36 weeks ]
Original Primary Outcome: Response rate assessed by a Tumor MRI scan every 6 weeks or if clinically indicated.
Current Secondary Outcome:
- Time to progression assessed by an MRI scan. [ Time Frame: Every 36 weeks ]
- Overall survival [ Time Frame: Every 36 weeks ]
- Safety and tolerability assessed by abnormal lab values (hematology, biochemistry, urinalysis), by physical examination and vital signs [ Time Frame: Every 36 weeks ]
Original Secondary Outcome:
- Time to progression assessed by a MRI scan.
- Overall survival
- Safety and tolerability
Information By: Novartis
Dates:
Date Received: January 25, 2007
Date Started: May 2006
Date Completion:
Last Updated: August 6, 2012
Last Verified: August 2012