Phase 1 Study of Oprozomib Administered Orally in Patients With Advanced Refractory or Recurrent Solid Tumors

Inclusion Criteria

• •Disease Related
• •* Histologically confirmed advanced solid tumor that is refractory or recurrent after standard treatments.
• •* At least one site of radiographically measurable disease of ≥ 2 cm in the largest dimension by traditional computed tomography (CT) scanning technique or ≥ 1 cm in the largest dimension by spiral CT scanning (per RECIST criteria); or if, in the Principal Investigator's opinion, evaluable disease can be reliably and consistently followed, the patient may be eligible upon approval by the Onyx Therapeutics, Inc., Medical Monitor.
• •Demographic
• •* Males and females ≥ 18 years of age
• •* Life expectancy of more than three months
• •* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• •Laboratory
• •* Adequate hepatic function, with bilirubin ≤ 1.5 times the upper limit of normal (ULN), and alanine aminotransferase (ALT) ≤ 3 times ULN or ≤ 5 times ULN in the presence of hepatic tumor involvement
• •* Absolute neutrophil count (ANC) ≥ 1500/mm3, hemoglobin ≥ 8 g/dL, and platelet count ≥ 100,000/ mm3
• •1. Screening platelet count must be independent of platelet transfusions for at least one week
• •2. Screening ANC must be independent of granulocyte- and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least one week and of pegylated G-CSF for at least two weeks
• •3. Patients may receive red blood cell (RBC) transfusions or receive supportive care with erythropoietin or darbepoetin in accordance with institutional guidelines
• •* Calculated or measured creatinine clearance of ≥ 30 mL/min; calculation using a generally accepted formula such as that of Cockcroft and Gault: CrCl = \[(140 - Age) × Mass (kg) / (72 × Creatinine mg/dL)\], multiply by 0.85 if female
• •Ethical / Other
• •* Written informed consent in accordance with federal, local, and institutional guidelines
• •* Female patients of childbearing potential must have a negative serum or urine pregnancy test within three days of the first dose and agree to use dual methods of contraception during the study and for one month following the last dose of study drug. Post-menopausal females (\> 45 years old and without menses for \> 1 year) and surgically sterilized females are exempt from these requirements. Male patients must use an effective barrier method of contraception during the study and for one month following the last dose if sexually active with a female of childbearing potential.