RX-5902 Treatment of Subjects With Triple Negative Breast Cancer

Inclusion Criteria:

Male and female who are 18 yrs or older
Histologically confirmed triple negative breast cancer that are refractory, intolerant, or ineligible to receive approved standard therapies
Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST)
Life expectancy of at least 3 months
Able to swallow capsules
Provide written informed consent

Exclusion Criteria:

Primary brain tumor or active brain metastasis
Not recovered to less than or equal to Grade 1 toxicities (except Grade 2 alopecia or neuropathy) associated with previous cancer therapies
Any other cancer treatments within 2 weeks of planned study treatment
History of any medical or psychiatric condition or addictive disorder, or lab abnormality that in the opinion of the investigator, may increase risks or may interfere with study participation or interpretation of study results
History of clinically significant GI bleed, intestinal obstruction, or GI perforation within 6 months of study dose
Uncontrolled diabetes
History of long QT syndrome or clinically significant cardiac arrhythmias (except stable atrial fibrillation)
Myocardial infarction within 6 months of study dose
Active infection requiring IV antibiotics within 2 weeks of study dose
History of Hepatitis B, C, or HIV
Use of potent inhibitor or inducer of CYP3A4/3A5 within 14 days of planned study treatment or expected requirement for use of such a drug during study
Use of a potent inhibitor or inducer of drug transporters or conjugating enzymes within 14 days prior to planned study treatment or expected requirement for use of such a drug during study
Receiving other investigational agents or not yet completed 30 days since completion of an investigational study
Pregnant, planning a pregnancy, or breast feeding
Male or female not willing to use adequate contraceptive precautions during the study period. Females must either be surgically sterile, post-menopausal for 12 months, or use a contraceptive approved by sponsor.
Unwilling or unable to provide written informed consent, comply with study requirements, or be available for follow-up assessments