Clinical Trial Finder

Inclusion Criteria:

• - Male or female patients ≥18 years old with a life expectancy of at least 8 weeks.

• - Radiographically proven recurrent (≥ first relapse), intracranial Glioblastoma (GBM) - For all patients, availability of at least 10 unstained slides (or archival tumor block sufficient to generate at least 10 unstained slides) from any previous GBM surgery.

• - Previous treatment with external beam radiation and temozolomide chemotherapy.

• - Before the first dose of PLX3397,adequate recovery from toxicity of prior therapy as follows: >28 days for cytotoxic therapy >42 days for nitrosoureas >28 days for bevacizumab >7 days for non cytotoxic therapy such as interferon, tamoxifen, thalidomide, cis-retinoic acid, or erlotinib.

• - Women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose.

Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. Men of child-bearing potential must also agree to use an acceptable method of birth control while on study drug.

• - Karnofsky performance status of ≥60.

• - Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.0 x 109/L, Hgb >9 g/dL, platelet count ≥50 x 109/L, Aspartate aminotransferase/Alanine aminotransferase (AST/ALT) ≤2.5x Upper Limit of Normal (ULN), creatinine ≤1.5x ULN) - Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements.

Exclusion Criteria:

• - Investigational drug use within 28 days of the first dose of PLX3397.

• - GBM progression within 3 months of previous radiation by Response Assessment in Neuro-Oncology (RANO) criteria.

• - History of Grade 2 Common Toxicity Criteria for Adverse Events (CTCAE v4) or greater acute intracranial hemorrhage.

• - Previous failure of bevacizumab or other vascular endothelial growth factor (VEGF) therapy except in a first line setting.

• - History of malignant glioma with co-deletion of 1p/19q.

• - A concurrent active cancer that requires non-surgical therapy (e.g. chemotherapy, radiation, adjuvant therapy).

Prior history of other cancer is allowed, as long as there was no active disease within the prior 3 years.

• - Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption.

• - Patients with serious illnesses, uncontrolled infection, medical conditions, or other medical history including abnormal laboratory results, which in the investigator's opinion would be likely to interfere with a patient's participation in the study, or with the interpretation of the results.

• - Women of child-bearing potential who are pregnant or breast feeding.

- corrected QT interval (QTc) ≥450 msec at Screening

Arms

Experimental: PLX3397-Cohort 1

10 patients with recurrent glioblastoma who require reoperation will be treated with PLX3397 for 7 days prior to surgery and their tumor tissue will be evaluated for pharmacokinetic levels and pharmacodynamic effects.

Experimental: PLX3397-Cohort 2

30 patients will be orally dosed with PLX3397 continuously on 28 day cycles.

Interventions

Drug: - PLX3397

Capsules administered once or twice daily, continuous dosing