Nab-sirolimus in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma

Exclusion Criteria

• •A patient will not be eligible for inclusion in this study if any of the following criteria apply:
• •1. Co-medication or concomitant therapy that may interfere with study results, including anti-coagulants and enzyme-inducing anti-epileptic drugs (EIAEDs).
• •2. History of thrombotic or hemorrhagic stroke or myocardial infarction within 6 months.
• •3. Pregnant or breast feeding.
• •4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics \& psychiatric illness/social situations that would limit compliance with study requirements, or disorders associated with significant immunocompromised state.
• •5. Active gastrointestinal bleeding.
• •6. Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥90 mm Hg.
• •7. Patients with history of intestinal perforations, fistula, hemorrhages and/or hemoptysis ≤6 months prior to first study treatment.
• •8. Uncontrolled diabetes mellitus as defined by HbA1c \>8% despite adequate therapy.
• •9. Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension.
• •10. Use of strong inhibitors and inducers of CYP3A4 within the 14 days prior to receiving the first dose of ABI-009. Additionally, use of any known CYP3A4 substrates with narrow therapeutic window (such as fentanyl, alfentanil, astemizole, cisapride, dihydroergotamine, pimozide, quinidine, terfanide) within the 14 days prior to receiving the first dose of ABI-009.
• •11. Known other previous/current malignancy requiring treatment within ≤ 3 years except for limited disease treated with curative intent, such as in situ prostate cancer, intracapsular renal cancer, cervical carcinoma in situ, squamous or basal cell skin carcinoma, and superficial bladder carcinoma.
• •12. Any comorbid condition that restricts the use of study drug and confounds the ability to interpret data from the study as judged by the Investigator or Medical Monitor.
• •13. Known Human Immunodeficiency Virus (HIV), or active Hepatitis B or Hepatitis C.