A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma

Официальное название

A Phase 2, Single-Arm, Multicenter, Open-Label Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma

Обзор

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

Вмешательства

• Препарат Zanzalintinib
  Administered as specified in the treatment arm.

Первичные конечные точки

• Objective Response Rate (ORR) per Response Assessment in Neuro-oncology (RANO) as Assessed by Blinded Independent Central Review (BICR) [Срок оценки: Up to approximately 12 months]

Вторичные конечные точки (7)

• Progression-free Survival at 6 Months (PFS-6) per RANO as Assessed by BICR and Investigator [Срок оценки: Up to 6 months]
• Duration of Response (DOR) per RANO as Assessed by BICR and Investigator [Срок оценки: Up to approximately 48 months]
• Progression-free Survival (PFS) per RANO as Assessed by BICR and Investigator [Срок оценки: Up to approximately 48 months]
• Overall Survival (OS) [Срок оценки: Up to approximately 48 months]
• Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Up to approximately 48 months]
• Change from Baseline in Neurologic Function as Measured by the Neurologic Assessment in Neuro-oncology (NANO) Scale Score [Срок оценки: Baseline up to approximately 13 months]
• Change from Baseline in Health-related Quality of Life (HRQoL) as Measured by the EuroQol 5-dimension 5-level Questionnaire (EQ-5D-5L) Score [Срок оценки: Baseline up to approximately 13 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.
• 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, intracranial hemorrhage/bleeding), or
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 12 центров

• University of Alabama — Birmingham
• Mayo Clinic_Arizona — Phoenix
• Mayo Clinic_Jacksonville — Jacksonville
• Baptist Health Miami Cancer Institute — Miami
• Washington University School of Medicine — St Louis
• Memorial Sloan-Kettering Cancer Center — New York
• Mayo Clinic_Rochester — Rochester
• Duke University — Durham
• … и ещё 4 центра

Идентификаторы

NCT: NCT07428616 · XL092-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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