A Crossover Bioequivalence Study of Intravenously Administered ATI0918 and DOXIL/CAELYX in Patients With Ovarian Cancer

Exclusion Criteria

• •1. Have New York Heart Association (NYHA) Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Day 1, unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG) or during Cardiac Stress Testing within 14 days prior to Day 1
• •2. Have received \> 250 mg/m2 of doxorubicin or equivalent as other anthracyclines or similar compounds
• •3. Have received prior treatment with DOXIL/CAELYX
• •4. Have received radiotherapy to the mediastinal area or concomitant therapy with other potentially cardiotoxic agents
• •5. Have seizure disorders requiring anticonvulsant therapy
• •6. Have known brain metastases (unless previously treated and well controlled for a period of \>/= 3 months)
• •7. Have severe chronic obstructive pulmonary disease with hypoxemia
• •8. Have had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1
• •9. Have an active, uncontrolled bacterial, viral, fungal, or other opportunistic infections requiring systemic therapy
• •10. Are pregnant or nursing. NOTE: Nonsterile women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
• •11. Have received treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to study entry (6 weeks for nitrosoureas or Mitomycin C).
• •12. Have received radiation therapy to \>25% of her total bone marrow during her lifetime
• •13. Are unwilling or unable to comply with procedures required in this protocol
• •14. Have known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• •15. Have a serious nonmalignant disease (e.g., hydronephrosis, liver failure, significantly impaired hepatic function, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
• •16. Are currently receiving any other investigational agent
• •17. Have exhibited allergic reactions to doxorubicin or a similar structural compound