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Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors

Primary Purpose

Malignant Peripheral Nerve Sheath Tumors

Status

Terminated

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

imatinib mesylate

About this trial

This is an interventional treatment trial for Malignant Peripheral Nerve Sheath Tumors focused on measuring Malignant,, peripheral,, nerve sheath tumors,, MPNST,, neurofibromatosis,, NF1,, Imatinib mesylate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

STI571

Arm Description

Outcomes

Primary Outcome Measures

Response rate assessed by a Tumor MRI scan every 6 weeks or if clinically indicated.

Secondary Outcome Measures

Time to progression assessed by an MRI scan.

Overall survival

Safety and tolerability assessed by abnormal lab values (hematology, biochemistry, urinalysis), by physical examination and vital signs

Full Information

NCT ID

NCT00427583

First Posted

January 25, 2007

Last Updated

August 6, 2012

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00427583

Brief Title

Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Terminated

Why Stopped

stopped due to slow recruitment and no effect

Study Start Date

May 2006 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Peripheral Nerve Sheath Tumors

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

STI571

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

imatinib mesylate

Primary Outcome Measure Information:

Title

Response rate assessed by a Tumor MRI scan every 6 weeks or if clinically indicated.

Time Frame

Every 36 weeks

Secondary Outcome Measure Information:

Title

Time to progression assessed by an MRI scan.

Time Frame

Every 36 weeks

Title

Overall survival

Time Frame

Every 36 weeks

Title

Safety and tolerability assessed by abnormal lab values (hematology, biochemistry, urinalysis), by physical examination and vital signs

Time Frame

Every 36 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmeceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Berlin

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

Country

Germany

12. IPD Sharing Statement

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Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors

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