Malignant Peripheral Nerve Sheath Tumors
Conditions
Keywords
Malignant,, peripheral,, nerve sheath tumors,, MPNST,, neurofibromatosis,, NF1,, Imatinib mesylate
Brief summary
This study assesses the safety and efficacy of imatinib mesylate treatment of patients with malignant peripheral nerve sheath tumors
Interventions
DRUGimatinib mesylate
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate assessed by a Tumor MRI scan every 6 weeks or if clinically indicated. | Every 36 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression assessed by an MRI scan. | Every 36 weeks |
| Overall survival | Every 36 weeks |
| Safety and tolerability assessed by abnormal lab values (hematology, biochemistry, urinalysis), by physical examination and vital signs | Every 36 weeks |
Countries
Germany
Outcome results
None listed