A Phase I, Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of RRx-001 in Subjects With Advanced Solid Tumors or Lymphomas For Which There Are No Currently Accepted Curative Therapies
- 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
- 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.
- 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
- 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
- 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
- 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
- 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