Selinexor Combination Ph 1 Study

Who cannot join

• Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study, or those who have not recovered from AEs due to agents administered more than 2 weeks earlier. Patients must be >/= 2 weeks since any investigational agent was administered as part of an exploratory IND study and should have recovered to eligibility levels from any toxicity.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrythmia, prolonged QTc interval (>500 msec), or psychiatric illness/social situations that would limit compliance with study requirements.
• In the Food and Drug Administration (FDA) Use-in-Pregnancy Ratings for Drugs, Irinotecan is classified as category D drugs, indicating that investigational or postmarketing data show risk to the fetus. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after completion of study. Should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician immediately. Because there is a risk for AEs in nursing infants secondary to treatment of the mother with these drugs, breastfeeding should be discontinued while the patient is on this trial and for 30 days after completion of treatment on this trial.
• Patients with known brain metastases are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status is stable with or without treatment without steroids (except for maintenance replacement doses of steroids).
• Patients with clinically significant illnesses which could compromise participation in the study, including, but not limited to, active or uncontrolled infection, immune deficiencies or confirmed diagnosis of HIV infection, Hepatitis B, Hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements are excluded from this trial.
• Grade >/= 3 toxicity related to irinotecan for patients who have received prior irinotecan.
• Both men and women of all races and ethnic groups are eligible for this trial.