Safety and PK Study of RRx-001 in Cancer Subjects (DINAMIC)

Inclusion Criteria:

• Subject is male or female, aged at least 18 years.
• Subject has a histologically or cytologically confirmed diagnosis of an advanced, malignant, incurable solid tumor(s) or lymphoma that is metastatic and/or unresectable and/or for which standard curative measures either are not applicable, or do not exist, or are no longer effective. Subjects with curative treatment options are not eligible for the protocol.
• Subject is not receiving any active treatment for his/her malignancy (except for prostate cancer subjects receiving luteinizing hormone-releasing hormone (LHRH) agonists and antiandrogens such as: Flutamide, Dutasteride, and Finasteride).
• Subject's Eastern Cooperative Group (ECOG) performance status is 0, 1 or 2 at Screening.
• Subject has acceptable liver function at Screening
• Subject has a normal serum creatinine.
• Subject has acceptable hematologic status at Screening
• Female subjects of childbearing potential (i.e., women who have not been surgically sterilized or have not been post-menopausal for at least one year), and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception beginning on Study Day 1 and continuing until at least four weeks after administration of the subject's final dose of RRx-001.

Exclusion Criteria:

• Impaired cardiac function that in the opinion of the Investigator could interfere with the conduct of the study or could put the subject at unacceptable risk.
• Right-to-left, bidirectional, or transient right-to-left cardiac shunts.
• Subjects with a history of acute cerebral infarction or TIAs within 90 days prior to Study Day 1.
• Acute myocardial infarction or acute coronary syndromes less than one year prior to enrollment.
• Serious ventricular arrythmias or high risk for arrhythmias due to prolongation of the QT interval.
• Subjects who experienced a major surgery, radiotherapy, or immunotherapy within the last 21 days prior to Study Day 1 (limited palliative radiation is allowed within 14 days prior to Study Day 1).
• Chemotherapy regimens with delayed toxicity within the 28 days prior to Study Day 1 (except for nitrosourea or mitomycin C treatments within 42 days prior to Study Day 1).
• Chemotherapy regimens given continuously or on a weekly basis that Investigator believes to have a limited potential for delayed toxicity within 14 days prior to Study Day 1.
• Use of an investigational anti-cancer drug within 42 days prior to Study Day 1.
• Subject has symptomatic and/or untreated central nervous system metastases and/or intracranial hypertension.
• Subject has a known history of an active and/or an uncontrolled infection with hepatitis A or hepatitis B.
• Subject with a known history of a positive HIV status.
• Subjects with pulmonary edema.
• Subjects with respiratory failure
• Subjects with severe emphysema, pulmonary emboli, pulmonary fibrosis or other conditions that cause pulmonary hypertension due to compromised pulmonary arterial vasculature.
• Subjects with Raynaud's syndrome.
• Subjects with a serious co-morbid medical condition.
• If female, subject is pregnant and/or breastfeeding.
• Any subject with congenital or acquired methemoglobinemia.
• Any subject with a history of inherited anemia or hemoglobinopathy including but not limited to hereditary spherosytosis, hereditary elliptocytosis, hereditary ovalocytosis,