| Exclusion Criteria: | 1) Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 28 days prior to receipt of study medication (6 weeks for nitrosoureas or mitomycin C; 12 weeks for radioimmunotherapy). Major surgery, other than diagnostic surgery, within 4 weeks before first study drug administration. Radiotherapy within 4 weeks.
2) Patients that require G-CSF and/or platelet support during screening or are likely to require G-CSF and/or platelet support for the duration of the clinical trial.
3) Patients with ongoing coagulopathies and/or taking anticoagulants (warfarin, heparin or low molecular weight heparin) (low dose anticoagulants for IV port maintenance or DVT prophylaxis are permitted).
4) Patients with prior bone marrow transplant therapy (autologous or allogeneic)
5) Patients receiving intrathecal therapy. Patients need to be off IT therapy at least 3 months.
6) Known brain metastases
7) Pre-existing adrenal insufficiency; concomitant therapy with replacement corticosteroids. Pre-existing acute or chronic pancreatitis.
8) Significant cardiac disease defined as: patients with congenital long QT syndrome; congestive heart failure of Class III or IV of the NYHA classification; history of myocardial infarction or active ischemia within 12 months of study enrollment; patients with mean QTcF interval >/= 500 msec identified on three screening ECGs obtained at least 5 minutes apart; interval determination will be based on the analysis performed by central ECG laboratory
9) Patients with a prior hypersensitivity reaction of CTCAE Grade >/= 3 to therapy containing propylene glycol or ethanol
10) Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile or they must agree to use acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicidal or condom with spermicide, abstinence) for the duration of the study and for one month following study completion. Female patients with child-bearing potential must have a negative serum pregnancy test within the 7 days before the first NPI-0052 administration. Male patients must be surgically sterile or agree to use an acceptable method of contraception.
11) 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).
12) Patients with proteinuria >/= Grade 2, untreated urinary tract infection, as well as any pre-exisiting kidney disease (acute or chronic) that would impose excessive risk to the patient.
13) Active uncontrolled bacterial or fungal infection requiring systemic therapy; infection requiring parenteral antibiotics
14) Known to be positive for HIV, Hepatitis A, B, or C.
15) Any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient. Examples of such conditions include infection requiring parenteral or oral anti-infective treatment, any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent.
16) Unwilling or unable to comply with procedures required in this protocol |