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.