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New treatment option for Meningioma
Official title A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma
ClinicalTrials.gov ID: NCT07428616
What this study is testing
What is Zanzalintinib?
Zanzalintinib is an investigational medicine, being studied as a potential treatment for meningioma.
Also referred to as XL092.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objective of the study is to evaluate efficacy and safety of zanzalintinib in participants with recurrent or progressive meningioma refractory to standard therapies.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Radiologically documented progression of any existing tumor (growth \> 15% of the bidimensional enhancing tumor within the prior 6 months or...
- For participants treated with external beam radiation, interstitial brachytherapy, or radiosurgery, an interval ≥ 24 weeks must have elapsed from...
- Measurable disease by RANO meningioma criteria as determined by the investigator, obtained ≤ 14 days prior to initiation of treatment.
You likely can't join if
- 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...
- Prior Surgery - completed wound healing must occur prior to initiation of treatment; ≥ 8 weeks for major surgery, ≥ 7 days for minor surgery...
See the full eligibility criteria
- 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...
- 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 Key
- 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 Surgery - completed wound healing must occur prior to initiation of treatment; ≥ 8 weeks for major surgery, ≥ 7 days for minor surgery, including stereotactic biopsies.
- The participant has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
- Cardiovascular disorders, including uncontrolled hypertension,
- Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation,
- Clinically significant hematuria, hematemesis, or hemoptysis of \> 0.5 teaspoon (2.5 milliliters [mL]) of red blood within 12 weeks before initiation of treatment or other history of significant bleeding (eg...
- Other clinically significant disorders.
- Requirement for hemodialysis or peritoneal dialysis.
- History of solid organ or allogeneic stem cell transplant. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Bay Saint Louis, Mississippi, United States
- New York, New York, United States
- Rochester, New York, United States
- Durham, North Carolina, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Jacksonville, Florida, United States; Miami, Florida, United States; Bay Saint Louis, Mississippi, United States; New York, New York, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.