Health TrialsbyHealthPanel

A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma

ConditionMeningioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorExelixis

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Zanzalintinib

    Drug

    Administered as specified in the treatment arm.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: ZanzalintinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR) per Response Assessment in Neuro-oncology (RANO) as Assessed by Blinded Independent Central Review (BICR)

Time frame
Up to approximately 12 months

Secondary outcomes

1

Progression-free Survival at 6 Months (PFS-6) per RANO as Assessed by BICR and Investigator

Time frame
Up to 6 months
2

Duration of Response (DOR) per RANO as Assessed by BICR and Investigator

Time frame
Up to approximately 48 months
3

Progression-free Survival (PFS) per RANO as Assessed by BICR and Investigator

Time frame
Up to approximately 48 months
4

Overall Survival (OS)

Time frame
Up to approximately 48 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Exelixis

Lead sponsor

Source ClinicalTrials.gov
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