Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Malignancies

Inclusion Criteria:

• Karnofsky Performance Status (KPS) > 70%.
• Histologically-confirmed advanced malignancy for which a standard, approved therapy is not available.
• Adequate renal, liver, pancreatic and hematologic function
• Signed informed consent (sample IC form is provided in Appendix A).

Exclusion Criteria

• Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 28 days
• Patients that require G-CSF and/or platelet support during screening and are likely to require G-CSF and/or platelet support for the duration of the clinical trial.
• Patients with ongoing coagulopathies and/or taking anticoagulants
• Patients receiving intrathecal therapy.
• Known brain metastases.
• Pre-existing adrenal insufficiency; concomitant therapy with replacement corticosteroids. Pre-existing acute or chronic pancreatitis.
• Significant cardiac disease.
• Pregnant or breast-feeding women.
• Concurrent, active secondary malignancy for which the patient is receiving therapy. (Lymphoma patients with a diagnosis of a potentially hormone-sensitive tumor who are without evidence of disease for this second malignancy may continue to receive hormonal therapy).
• Patients with proteinuria Grade 2 or greater
• Active uncontrolled bacterial or fungal infection requiring systemic therapy; infection requiring parenteral antibiotics.
• Patients who are known to be HIV positive or have active Hepatitis A, B, or C infection.