Study of Selinexor and Doxorubicin in Advanced Soft Tissue Sarcomas

Inclusion Criteria:

• Written informed consent
• Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
• Age ≥ 18 years.
• Patients must have histologically confirmed locally advanced/unresectable or metastatic soft tissue sarcoma.
• Patients must have not received prior doxorubicin.
• Patient must show evidence of progressive disease on study entry or newly diagnosed patients with de novo metastatic measurable disease
• Patient must have measureable disease as defined by RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Adequate hematopoietic function
• Adequate hepatic function:
• Adequate renal function
• Adequate cardiac function13
• Patients must agree to use methods of contraception as a agreed upon by the patient and study doctor

Exclusion Criteria:

• Patient is pregnant or lactating
• Radiation, chemotherapy, immunotherapy, any other systemic anticancer therapy, or participation in an investigational anti-cancer study ≤3 weeks prior to initiation of therapy.
• Major surgery within 4 weeks before initiation of therapy
• Unstable cardiovascular function
• Active, ongoing or uncontrolled active infection within one week prior to first dose.
• Malignancies other than disease under study within 2 years prior to Cycle 1, Day 1.
• Known to be HIV seropositive
• Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV) RNA or hepatitis B virus (HBV) surface antigen (HBsAg)
• Patients with active CNS malignancy.
• Patients with any gastrointestinal dysfunctions that could interfere with the absorption of Selinexor or patients with significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea.
• Inability or unwillingness to take supportive medications such as anti-nausea and anti anorexia agents.
• In the opinion of the Investigator, patients who are significantly below their ideal body weight
• Serious psychiatric or medical conditions that could interfere with treatment
• Concurrent therapy with approved or investigational anticancer therapeutic agents
• Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study regimen or interpretation of patient safety or study results