A Study of BBI608 in Adult Patients With Advanced Malignancies

Inclusion Criteria

• •1. Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures
• •2. For solid tumors or lymphoma, a histologically or cytologically confirmed solid tumor that is metastatic, unresectable, or recurrent and for which standard curative or palliative therapies do not exist or are no longer effective.
• •3. ≥ 18 years of age
• •4. For solid tumors, measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
• •5. For lymphoma, measurable disease as defined by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma
• •6. For multiple myeloma, measurable disease as defined by the International Uniform Response Criteria for Multiple Myeloma
• •7. Karnofsky performance status greater than or equal to 70%
• •8. Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last BBI608 dose
• •9. Females of childbearing potential must have a negative serum pregnancy test
• •10. Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 1.5 × upper limit of normal(ULN)
• •11. Hemoglobin (Hgb) greater than or equal to 10 g/dl
• •12. Total bilirubin less than or equal to 1.5 × ULN
• •13. Creatinine less than or equal to 1.5 x ULN or creatinine clearance greater than 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. Creatinine \< 2.5 x ULN for multiple myeloma patients.
• •14. Absolute neutrophil count greater than or equal to 1.5 x 109/L
• •15. Platelets greater than or equal to 100 x 109/L
• •16. Life expectancy greater than or equal to 3 months