- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00427583
Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors
August 6, 2012 updated by: Novartis Pharmaceuticals
An Open-label Multicenter Phase II Study of Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors
This study assesses the safety and efficacy of imatinib mesylate treatment of patients with malignant peripheral nerve sheath tumors
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Berlin, Germany
- Novartis Investigative Site
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Hamburg, Germany
- Novartis Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: STI571
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate assessed by a Tumor MRI scan every 6 weeks or if clinically indicated.
Time Frame: Every 36 weeks
|
Every 36 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to progression assessed by an MRI scan.
Time Frame: Every 36 weeks
|
Every 36 weeks
|
Overall survival
Time Frame: Every 36 weeks
|
Every 36 weeks
|
Safety and tolerability assessed by abnormal lab values (hematology, biochemistry, urinalysis), by physical examination and vital signs
Time Frame: Every 36 weeks
|
Every 36 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
January 25, 2007
First Submitted That Met QC Criteria
January 26, 2007
First Posted (Estimate)
January 29, 2007
Study Record Updates
Last Update Posted (Estimate)
August 7, 2012
Last Update Submitted That Met QC Criteria
August 6, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Neuromuscular Diseases
- Neoplasms, Nerve Tissue
- Peripheral Nervous System Diseases
- Nervous System Neoplasms
- Neoplasms, Connective Tissue
- Sarcoma
- Peripheral Nervous System Neoplasms
- Neoplasms, Fibrous Tissue
- Fibrosarcoma
- Neurofibroma
- Nerve Sheath Neoplasms
- Neurofibrosarcoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Imatinib Mesylate
Other Study ID Numbers
- CSTI571BDE57
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Malignant Peripheral Nerve Sheath Tumors
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Memorial Sloan Kettering Cancer CenterAstex Pharmaceuticals, Inc.RecruitingMalignant Peripheral Nerve Sheath Tumors (MPNST)United States
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Oslo University HospitalMerck Sharp & Dohme LLCTerminatedMalignant Peripheral Nerve Sheath Tumour (MPNST)Norway
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National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | NF1 Mutation Positive Malignant Peripheral Nerve Sheath TumorUnited States
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Sarcoma Alliance for Research through CollaborationUnited States Department of Defense; Synta Pharmaceuticals Corp.CompletedSarcoma | Malignant Peripheral Nerve Sheath Tumors (MPNST)United States
-
Memorial Sloan Kettering Cancer CenterWashington University School of Medicine; University of California, Los Angeles and other collaboratorsTerminatedSarcoma | Leiomyosarcoma | Malignant Peripheral Nerve Sheath Tumor | Malignant Fibrous | Histiocytoma/Undifferentiated Pleomorphic SarcomaUnited States
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AdaptimmuneRecruitingOsteosarcoma | Neuroblastoma | Synovial Sarcoma | Malignant Peripheral Nerve Sheath Tumor (MPNST)United States
-
Memorial Sloan Kettering Cancer CenterBayerCompletedSarcoma | Leiomyosarcoma | Malignant Peripheral Nerve Sheath Tumor | Synovial SarcomaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingNeurofibromatosis Type 1 | Metastatic Malignant Peripheral Nerve Sheath Tumor | Recurrent Malignant Peripheral Nerve Sheath TumorUnited States
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University of FloridaEpizyme, Inc.RecruitingPeripheral Nerve Sheath TumorUnited States
-
University of Texas Southwestern Medical CenterWithdrawnPeripheral Nerve TumorsUnited States
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