Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors

Malignant Peripheral Nerve Sheath Tumors Clinical Trial

Official title:

An Open-label Multicenter Phase II Study of Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00427583
• Other study ID #: CSTI571BDE57
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: January 25, 2007
• Last updated: August 6, 2012
• Start date: May 2006

Study information

• Verified date: August 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This study assesses the safety and efficacy of imatinib mesylate treatment of patients with malignant peripheral nerve sheath tumors

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients =18 years of age

• Histologically documented diagnosis of malignant MPNST

• Unresectable local MPNST or metastatic MPNST and therefore incurable with any conventional multimodality approach Life expectancy of at least 6 months.

Exclusion criteria:

• Patient has received any other investigational agents within 28 days of first day of study drug dosing.

• Chemotherapy and or radiotherapy in between the last 6 weeks before study entry, surgery in between the last 14 days before study entry.

• Female patients who are pregnant or breast feeding or women of child bearing potential who are not using a highly effective method of birth control.

• Known CNS metastases

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Peripheral Nerve Sheath Tumors
• Nerve Sheath Neoplasms
• Neurilemmoma
• Neurofibroma

Intervention

Drug:
• imatinib mesylate

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate assessed by a Tumor MRI scan every 6 weeks or if clinically indicated.		Every 36 weeks	No
Secondary	Time to progression assessed by an MRI scan.		Every 36 weeks	No
Secondary	Overall survival		Every 36 weeks	No
Secondary	Safety and tolerability assessed by abnormal lab values (hematology, biochemistry, urinalysis), by physical examination and vital signs		Every 36 weeks	No