Combination Study Of SB-485232 (Interleukin 18) And Doxil For Advanced Stage Epithelial Ovarian Cancer

Exclusion Criteria

• •1. Significant cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal or autoimmune conditions that in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as participant in this trial;
• •2. Any severe concurrent disease or condition, including significant active autoimmune diseases such as rheumatoid arthritis, which in the judgment of the principal investigator, would make the subject inappropriate for study participation;
• •3. History of myocardial infarction, unstable angina, or acute coronary syndrome within the past six months;
• •4. The subject has a history of hypersensitivity reactions to a conventional formulation of doxorubicin HCl or the components of pegylated liposomal doxorubicin;
• •5. The subject has a history of receiving a total cumulative dosage of doxorubicin HCl exceeding the currently recommended limit of 550 mg/m\^2 or will exceed the 550 mg/m\^2 dosage limit during the course of the current study. A subject will also be excluded if they received a lower cumulative dosage of doxorubicin HCl (i.e., 400 mg/m\^2) and also had prior radiotherapy to the mediastinal area or concomitant therapy with other potentially cardiotoxic agents such as cyclophosphamide. Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative doxorubicin HCl dosage;
• •6. Women who are pregnant or are breast-feeding;
• •7. Corrected QT interval (QTc) ≥480 msec (average of three measurements to be made at screening);
• •8. The subject has diabetes mellitus with poor glycemic control;
• •9. The subject has a history of human immunodeficiency virus (HIV) or other immunodeficiency disease;
• •10. The subject has positive Hepatitis B surface antigen;
• •11. The subject has a history of a severe infusion-related reaction following treatment with pegylated liposomal doxorubicin as described in the protocol;
• •12. The subject has an acute infection or severe or uncontrolled infections requiring systemic antibiotic therapy;
• •13. Any serious medical or psychiatric disorder that would interfere with subject safety or informed consent;
• •14. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol;
• •15. Known leptomeningeal disease or evidence of prior or current metastatic brain disease. Routine screening with central nervous system (CNS) imaging studies (CT or MRI) is required only if clinically indicated;
• •16. Receiving concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy;
• •17. Oral corticosteroids within 14 days of study entry;
• •18. History of ventricular arrhythmias requiring drug or device therapy;
• •19. Any investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of SB-485232;
• •20. The subject has active signs of a bowel obstruction.