Selinexor in Combination With Irinotecan in Adenocarcinoma of Stomach and Distal Esophagus

Exclusion Criteria

• •Have had chemotherapy, biologic therapy or radiotherapy within 3 weeks prior to entering the study
• •Are receiving any other investigational agents for anti-cancer treatment within 3 weeks of starting study medication
• •Symptomatic central nervous system (CNS) metastases
• •Progression on irinotecan containing regimen
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to irinotecan
• •Major surgery within 2 weeks before cycle 1 Day 1 (C1D1)
• •Unstable cardiovascular function
• •Patients who are pregnant or lactating
• •Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study.
• •Known active hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen)
• •Any underlying condition that would significantly interfere with the absorption of an oral medication
• •\> Grade 2 peripheral neuropathy at baseline
• •Serious psychiatric or medical conditions that could interfere with treatment
• •Concurrent therapy with approved or investigational anticancer therapeutic other than steroids
• •History of gastrointestinal perforation and/or fistulae within 6 months prior to C1D1
• •Use of strong CYP3A4 inducers or inhibitors within 2 weeks of starting study medication