Study of Tesevatinib Monotherapy in Patients With Recurrent Glioblastoma

Inclusion Criteria

• Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator
• Age ≥ 18 years old
• Kamofsky performance status ≥70%
• Stable or decreasing dose of corticosteroids within 5 days prior to study 5. enrollment.
• For women who are not postmenopausal (i.e., 1.5 x ULN.
• K+ or Mg+ 1.5 or PT > 1.5 xULN or aPTT > 1.5 xULN Therapeutic anticoagulation.
• Known contraindication to MRI, such as cardiac pacemaker, shrapnel or ocular foreign body.
• Used any prescription medication during the prior 2 weeks that the investigator judges is likely to interfere with the study or to pose an additional risk to the patient in participating, specifically inhibitors or inducers of cytochrome P450 (CYP)3A4 (refer to Appendix 5). A stable regimen (≥ 4 weeks) of antidepressants of the selective serotonin re-uptake inhibitor (SSRI) class is allowed (common SSRIs include escitalopram oxalate, citalopram, fluvoxamine, paroxetine, sertraline, and fluoxetine).
• Taking any drugs associated with torsades de pointes or known to moderately or severely prolong the QTc(F) interval
• History of torsades de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia ( 200 mg/dL
• New York Heart Association (NYHA) Grade II or greater congestive cardiac failure.
• Has marked prolongation of QTc(F) interval at screening or baseline (QTc[F] interval > 470 msec) using the Fridericia method of correction for heart rate.
• History of myocardial infarction (within 12 months) or unstable angina (within 6 months) prior to study enrolment.
• History of stroke or transient ischemic attacks within 6 months prior to study enrolment.
• Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to study enrolment.
• Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
• History of intracranial abscess within 6 months prior to study enrolment.
• History of another malignancy in the previous 3 years, with a disease-free interval of < 3 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
• Evidence of any active infection requiring hospitalization or IV antibiotics within 2 weeks prior to study enrolment.
• Known hypersensitivity to any excipients of tesevatinib.
• Inability to swallow or absorb orally-administered medication.