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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Malignant Peripheral Nerve Sheath Tumors

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Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Every 36 weeks

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmeceuticals

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CSTI571BDE57

NCT ID:

NCT00427583

Start Date:

May 2006

Completion Date:

Related Keywords:

  • Malignant Peripheral Nerve Sheath Tumors
  • Malignant,
  • peripheral,
  • nerve sheath tumors,
  • MPNST,
  • neurofibromatosis,
  • NF1,
  • Imatinib mesylate
  • Nerve Sheath Neoplasms
  • Neurofibrosarcoma
  • Neurilemmoma

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