A Study of NM-3 Administered Orally in Patients With Advanced Solid Tumors.

Inclusion Criteria:

• Adult patients at least 18 years of age.
• All patients must have an advanced solid tumor that has failed standard therapy or for which no standard therapy exists.
• Histological or cytological diagnosis of a malignant solid tumor.
• Measurable or non-measurable disease.
• Any chemotherapy, radiotherapy, or major surgery at least 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C). Patients must have recovered from the toxic effects of any prior therapy.
• Karnofsky performance status index greater than or equal to 80.
• Must have adequate organ and immune system function according to the study design, obtained less than or equal to 7-days prior to treatment with NM-3.
• Female patients of childbearing potential must have a negative serum pregnancy test within 7 days of study enrollment. Men and women with reproductive potential must use an effective contraceptive method while enrolled in this study and for 3 months after the patient has completed study.
• Patient must be able to swallow.
• Signed, written informed consent from patient or guardian.
• Estimated life expectancy of at least 12 weeks.

Exclusion Criteria:

• Known sensitivity to study drug or its analogs.
• Treatment with any investigational therapy within the preceding 4 weeks.
• Patients with hematological malignancies including leukemia, lymphoma, or multiple myeloma.
• Active and uncontrolled infection.
• Psychiatric disorders, alcohol or chemical abuse that would interfere with consent or follow-up.
• Uncontrolled congestive heart failure or angina.
• Pregnancy or lactation.
• Any other severe concurrent disease, which as judged by the investigator, would make the patient inappropriate for entry into this study.
• Patients with active gastrointestinal bleeding or ulceration, unhealed wounds or active thrombosis.
• Patients who are on anticoagulant therapy or taking aspirin, nonsteroidal anti-inflammatory drugs, unfractionated heparin, low molecular weight heparin, danaproid, thrombolytic agents, anti-platelet antibodies, glycoprotein IIb, IIIa antagonists, H2 blockers, or proton pump inhibitors.
• Brain or leptomeningeal metastases.
• Patients known to be HIV positive or who have an AIDS-related illness.
• Patients with a history of gastrointestinal bleeding from varices, arteriovenous malformations, Osler Weber Rendu syndrome, polyps, prior surgery, or gastric ulcerations. Patients who had bleeding not associated with a coagulopathy after surgery or gastric ulceration and who have no further bleeding or recurrence of their ulcers for more than one year are eligible for this study.
• Patients with a total accumulated doxorubicin or equivalent dose over 450 mg/m2.
• Patients with more than 1 risk factor, where a risk factor is defined as any one of the following (1-7):1. prior anthracyclines larger than 300 mg/m2 doxorubicin equivalent.2.mediastinum/left breast irradiation. 3.history of arterial hypertension (systolic blood pressure greater than 140 or diastolic blood pressure greater than 90, or receiving anti-hypertensive treatment).4. obesity (body mass index (BMI)[30]).5. diabetes mellitus (fasting plasma glucose level greater than 126 mg/dL American Diabetes Association (ADA) guidelines).6. smoking (any smoking in the month prior to study entry).7. hypercholesterolemia (greater than 240 mg/dL).