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Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors

NCT ID: NCT00427583

Last Updated: 2012-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Brief Summary

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

Detailed Description

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Conditions

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Malignant Peripheral Nerve Sheath Tumors

Keywords

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Malignant, peripheral, nerve sheath tumors, MPNST, neurofibromatosis, NF1, Imatinib mesylate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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STI571

Group Type EXPERIMENTAL

imatinib mesylate

Intervention Type DRUG

Interventions

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imatinib mesylate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmeceuticals

Locations

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Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CSTI571BDE57

Identifier Type: -

Identifier Source: org_study_id