Phase II Trial of SMO/AKT/NF2/CDK Inhibitors in Progressive Meningiomas with SMO/AKT/NF2/CDK Pathway Mutations

January 18, 2022

Protocol – Alliance A071401

Please Note: Below is partial eligibility, please contact GHCI Research Department at (810)762-8181, (810)762-8079 or (810)762-8038 for full eligibility requirements. Thank you!

SCHEMA Alliance A071401

Eligibility:

Pre-Registration:

  1. Local diagnosis of meningioma and have tissue available for central path review and integral biomarker testing.

Registration Eligibility:

  1. Presence of specific SMO/PTCH1, NF2 or AKT1/PIK3CA./CDK pathway mutations.
  2. Progressive or residual disease.
  3. Measurable disease as defined by a bi-dimensionally measurable.
  4. Target lesion on MRI brain or CT head images (MRI preferred).
  5. No chemotherapy, other investigational agents within 28 days of study treatment.
  6. No other concurrent investigational agents or other meningioma directed therapy (chemotherapy, radiation)
  7. Greater than 24 weeks must have elapsed from completion of radiation treatment (XRT, brachytherapy, radiosurgery) to registration.
  8. Steroid dosing stable for at least 4 days prior to registration.
  9. ECOG Performance Status 0-2.
  10. Stable for lesions for 6 months for patients with history of NF.
  11. No metastatic meningiomas.
  12. No history of allergic reactions attributed to compounds of similar biologic composition to assigned study drug.

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