Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors

Novartis

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Malignant Peripheral Nerve Sheath Tumors

Treatments: Drug: imatinib mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00427583

CSTI571BDE57

Details and patient eligibility

About

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

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

STI571

Experimental group

Treatment:

Drug: imatinib mesylate