A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer
Trial Parameters
Brief Summary
This study will test an investigational drug called AZD1390 in combination with radiation therapy for the treatment of brain tumors. This is the first time AZD1390 is being given to patients. This study will test safety, tolerability and PK (how the drug is absorbed, distributed and eliminated) of ascending doses of AZD1390 in combination with distinct regimens of radiation therapy
Eligibility Criteria
Inclusion Criteria: * Provision of formalin-fixed paraffin embedded tissue sample from primary or metastatic disease * Karnofsky Performance Score of ≥60. * Additional Inclusion Criteria Specific for Arm A and Japan: * Histologically proven diagnosis of GBM. Patients who have had RT for low-grade glioma (LGG) or grade 3 glioma and have subsequently relapsed to histologically confirmed GBM can be considered * A radiological diagnosis of recurrent/relapsed or progressive disease according to RANO criteria. * Completion of first-line radiation at least 6 months prior to Cycle 1 Day 1. * Patients with tumor-induced seizures must be well controlled on a stable anti-epileptic treatment * Willing to receive anti-epileptic prophylaxis for the duration of study drug administration. * Additional Inclusion Criteria Specific for Arm B: \*\*Arm B has now closed to recruitment\*\* * Histologically proven diagnosis of solid tumor malignancy and Magnetic Resonance (MR) imaging documenting brain lesion