General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT07428616

Background Information

The objective of the study is to evaluate efficacy and safety of zanzalintinib in participants with recurrent or progressive meningioma refractory to standard therapies.

For more information, visit: https://clinicaltrials.gov/study/NCT07428616

Offered At

Inova Schar Cancer Institute
A division of Inova Fairfax Hospital
8081 Innovation Park Drive 
Fairfax, VA 22031
Principal Investigator

Meaghan Roy-O'Reilly, MD

Eligibility Information

  • Histologically confirmed World Health Organization (WHO) grade 1, 2, or 3 meningioma.
  • Developed recurrent disease or progressive disease (PD) after receiving standard therapy (for example, surgery and/or radiation) or have been deemed ineligible to receive these therapies. At least 1 prior course of meningioma-directed radiotherapy is required, if not contraindicated.
  • Radiologically documented progression of any existing tumor (growth > 15% of the bidimensional enhancing tumor within the prior 6 months or appearance of new lesions (including intra and extracranial manifestations).
  • For participants treated with external beam radiation, interstitial brachytherapy, or radiosurgery, an interval ≥ 24 weeks must have elapsed from completion of therapy to initiation of treatment.
  • Measurable disease by RANO meningioma criteria as determined by the investigator, obtained ≤ 14 days prior to initiation of treatment.
  • Karnofsky performance status (KPS) ≥ 60%.
  • Demonstrate adequate organ and marrow function within 14 days of treatment initiation

Ineligibility Information

  • Prior history of hypertensive encephalopathy at any time.
  • Extracranial lesions invading major blood vessels including, but not limited to, inferior vena cava, pulmonary artery, or aorta.
  • Contraindication to magnetic resonance imaging (MRI).
  • Local therapy (surgery and/or radiation therapy) is indicated per investigator
  • Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks or 5 half-lives, whichever is shorter, before initiation of treatment. There is no limit on prior systemic therapies
  • Prior Surgery - completed wound healing must occur prior to initiation of treatment; ≥ 8 weeks for major surgery, ≥ 7 days for minor surgery, including stereotactic biopsies.
  • Requirement for hemodialysis or peritoneal dialysis.
  • History of solid organ or allogeneic stem cell transplant.