Phase I Study of LB-100 With Docetaxel in Solid Tumors

Exclusion Criteria

• •1. Patients may not have had prior chemotherapy, radiotherapy, hormonal therapy, or biologic therapy in the 4 weeks prior to study entry with the exception of mitomycin C or nitrosoureas, for which patients must be 6 weeks from prior treatment. For patients who have been treated with targeted therapy, 5 half-lives of that therapy (or 28 days, whichever is shorter) must have passed prior to enrollment in the study.
• •2. Part 2 only: Patients may not have had prior treatment with docetaxel.
• •3. Part 2 only: Patients with plasma total bilirubin \> ULN; ALT and/or AST \> 1.5 X ULN concomitant with alkaline phosphatase \> 2.5 X ULN.
• •4. Patients may not have any concomitant condition that could compromise the objectives of this study and the patients' compliance and ability to tolerate this therapy and complete at least 2 cycles of therapy, including, but not limited to the following:
• •* Congestive heart failure or uncontrolled angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension, or dysrhythmias.
• •* Active infection.
• •* Unstable diabetes mellitus.
• •* Psychiatric disorder that may interfere with consent and/or protocol compliance.
• •* Uncontrolled seizure activity.
• •* Prior history of inflammatory bowel disease.
• •* Prior history of pulmonary fibrosis.
• •* Prior history of cardiomyopathy.
• •5. Patients with a history of central nervous system (CNS) malignancy.
• •6. Pregnant or breastfeeding women.
• •7. Patients with another malignancy in the past 3 years except: curatively treated non-melanoma skin cancer, or carcinoma in situ (either cervix or breast) that does not require further treatment.
• •8. Patients with known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
• •9. Part 2 only: Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 (for example, drugs formulated with polysorbate 80 include, but are not limited to: Aranesp, Eprex, Cordarone, some vaccines).
• •10. Part 2 only: Patients with \>= grade 2 peripheral neuropathy.
• •11. Patients with an underlying diagnosis or disease state associated with an increased risk of bleeding.