AZD2014 In NF2 Patients With Progressive or Symptomatic Meningiomas (NCT02831257) | Clinical Trial Compass
CompletedPhase 2
AZD2014 In NF2 Patients With Progressive or Symptomatic Meningiomas
United States18 participantsStarted 2016-08-31
Plain-language summary
The goal of this clinical research study is to learn if the study drug AZD2014 can shrink growing or symptomatic meningiomas.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have a confirmed diagnosis of neurofibromatosis 2 by fulfilling National Institute of Health (NIH) criteria or Manchester criteria, or by detection of a causative mutation in the NF2 gene.
* Participants must have progressive or symptomatic meningioma. NOTE 1: Histologic confirmation of meningioma is not required in the setting of compatible radiographic appearance, NOTE2: progression is defined as an increase in target meningioma volume ≥ 20% OR ≥ 3 mm during the past 2 years.
\-- Subjects must have a target meningioma that is not amenable to surgery due to patient preference or high risk for surgical complications
* Participants must be willing and able to undergo regular MRI scans of the brain
* Patients must have measurable disease, defined as at least one meningioma ≥ 1.0 ml that can be accurately measured by contrast-enhanced cranial MRI scan, performed within 28 days of study registration.
* Prior surgical resection and radiation therapy for the progressive meningioma are not required for study enrollment.
* Patients must have received less than 3 prior chemotherapy regimens for progressive meningioma.
* Patients receiving dexamethasone must be able to be treated with alternative corticosteroids such as prednisone, prednisolone, or methylprednisolone in the opinion of the treating physician.
* Patients must have available an archival paraffin tumor block sufficient to generate at least 20 unstained slides; or, if a paraffin tumor…